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TerminatedNCT04333147contRAst XUpdated Feb 7, 2024Results posted

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

A Phase 3 interventional study of Otilimab (GSK3196165) and csDMARD(s) in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline. Terminated at 377 sites in 27 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Why this study was terminated
Study is early terminated due to Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.
Phase
Phase 3
Study type
Interventional
Enrollment
2,916
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

02

Conditions studied

  • Arthritis, Rheumatoid

Keywords

  • Rheumatoid arthritis
  • GSK3196165
  • Otilimab
  • Long-term safety
  • Long-term efficacy
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 2,916 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants with rheumatoid arthritis who are aged >=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
  • Body weight >=40 kilograms (kg).
  • Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).

Exclusion criteria

Exclusion Criteria:

  • Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.

  • Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that

    • Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
    • Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
  • Current or previous active TB regardless of treatment.
  • Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
  • A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
  • Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
  • Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
  • Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
  • Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
  • Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
  • Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
  • History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,916 participants (actual)

Study arms

  • Experimental
    Otilimab 90 mg

    Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.

    Biological: Otilimab (GSK3196165) · Drug: csDMARD(s)

  • Experimental
    Otilimab 150 mg

    Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.

    Biological: Otilimab (GSK3196165) · Drug: csDMARD(s)

Interventions

  • BiologicalOtilimab (GSK3196165)

    GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

  • DrugcsDMARD(s)

    Stable dose of csDMARD(s) as standard of care (SoC).

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.

    Time frame: Up to approximately 145 Weeks

  2. Change From Baseline in Hematology Parameter of Platelet Count at Week 24

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Time frame: Baseline (Day 01) and Week 24

  3. Change From Baseline in Hematology Parameter of Platelet Count at Week 48

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Time frame: Baseline (Day 01) and Week 48

  4. Change From Baseline in Hematology Parameter of Platelet Count at Week 96

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Time frame: Baseline (Day 01) and Week 96

  5. Change From Baseline in Hematology Parameter of Platelet Count at Week 144

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Time frame: Baseline (Day 01) and Week 144

  6. Change From Baseline in Hematology Parameter of Hemoglobin at Week 24

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Time frame: Baseline (Day 01) and Week 24

  7. Change From Baseline in Hematology Parameter of Hemoglobin at Week 48

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Time frame: Baseline (Day 01) and Week 48

  8. Change From Baseline in Hematology Parameter of Hemoglobin at Week 96

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Time frame: Baseline (Day 01) and Week 96

  9. Change From Baseline in Hematology Parameter of Hemoglobin at Week 144

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Time frame: Baseline (Day 01) and Week 144

  10. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Time frame: Baseline (Day 01) and Week 24

  11. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Time frame: Baseline (Day 01) and Week 48

  12. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Time frame: Baseline (Day 01) and Week 96

  13. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Time frame: Baseline (Day 01) and Week 144

  14. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Time frame: Baseline (Day 01) and Week 24

  15. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Time frame: Baseline (Day 01) and Week 48

  16. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Time frame: Baseline (Day 01) and Week 96

  17. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Time frame: Baseline (Day 01) and Week 144

  18. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Time frame: Baseline (Day 01) and Week 24

  19. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Time frame: Baseline (Day 01) and Week 48

  20. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Time frame: Baseline (Day 01) and Week 96

  21. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Time frame: Baseline (Day 01) and Week 144

  22. Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities

    Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.

    Time frame: Up to approximately 145 Weeks

  23. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Time frame: Baseline (Day 01) and Week 24

  24. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Time frame: Baseline (Day 01) and Week 48

  25. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Time frame: Baseline (Day 01) and Week 96

  26. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Time frame: Baseline (Day 01) and Week 144

Secondary outcomes

  1. Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144

    Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Percentage values are rounded off.

    Time frame: Week 24, 48, 96 and 144

  2. Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144

    Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off.

    Time frame: Week 24, 48, 96 and 144

  3. Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144

    The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.

    Time frame: Week 24, 48, 96 and 144

  4. Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132

    The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.

    Time frame: Week 24, 48, 96 and 132

  5. Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144

    Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI \<= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.

    Time frame: Week 24, 48, 96 and 144

  6. Absolute Values for Clinical Disease Activity Index (CDAI) Total Score

    CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

    Time frame: Week 24, 48, 96 and 144

  7. Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)

    The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

    Time frame: Week 24, 48, 96 and 144

  8. Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)

    The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

    Time frame: Week 24, 48, 96 and 132

  9. Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)

    Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity.

    Time frame: Week 24 and 48

  10. Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)

    The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.

    Time frame: Week 24, 48, 96 and 144

  11. Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)

    For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement.

    Time frame: Week 24, 48, 96 and 144

  12. Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)

    SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring.

    Time frame: Week 24, 48, 96 and 144

  13. Absolute Values SF-36 Domain Scores

    Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36.

    Time frame: Week 24, 48, 96 and 144

  14. Absolute Values SF-36 Physical Component Scores (PCS)

    SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring.

    Time frame: Week 24, 48, 96 and 144

  15. Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life.

    Time frame: Week 24, 48, 96 and 144

  16. Number of Participants With Anti-GSK3196165 Antibodies

    Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA

    Time frame: Week 120

07

Results

Posted Feb 7, 2024

Participant flow

Participants who consented, were enrolled and assigned to receive Otilimab 90 milligram (mg) or 150 mg weekly. Participants who received Otilimab in their qualifying study (202018, 201790 and 201791) were enrolled into this study on the same dose. Participants who received an active comparator in their qualifying study were centrally randomized using Interactive Response Technology (IRT) in a ratio of 1:1 to receive either Otilimab 90 mg or 150 mg weekly.

Participant flow — Overall Study
MilestoneOtilimab 90 mgOtilimab 150 mg
Started14561459
Completed00
Not completed14561459
Withdrew: Adverse event4340
Withdrew: Lack of efficacy4948
Withdrew: Lost to follow-up1916
Withdrew: Physician decision1720
Withdrew: Withdrawal by subject6568
Withdrew: Investigator site closed62
Withdrew: Protocol-specified withdrawal criterion met69
Withdrew: Study terminated by sponsor12511256

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.

Time frame:
Up to approximately 145 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
ParticipantsOtilimab 90 mgOtilimab 150 mg
Participants with AEs902931
Participants with SAEs123114
Participants with AESI12095
PrimaryChange From Baseline in Hematology Parameter of Platelet Count at Week 24

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Time frame:
Baseline (Day 01) and Week 24
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in Hematology Parameter of Platelet Count at Week 24
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Platelet Count at Week 24-11.9 ± 66.86-9.7 ± 66.82
PrimaryChange From Baseline in Hematology Parameter of Platelet Count at Week 48

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Time frame:
Baseline (Day 01) and Week 48
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in Hematology Parameter of Platelet Count at Week 48
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Platelet Count at Week 48-12.5 ± 66.47-7.6 ± 71.36
PrimaryChange From Baseline in Hematology Parameter of Platelet Count at Week 96

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Time frame:
Baseline (Day 01) and Week 96
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in Hematology Parameter of Platelet Count at Week 96
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Platelet Count at Week 96-13.8 ± 60.72-5.7 ± 72.81
PrimaryChange From Baseline in Hematology Parameter of Platelet Count at Week 144

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Time frame:
Baseline (Day 01) and Week 144
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in Hematology Parameter of Platelet Count at Week 144
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Platelet Count at Week 14417.0 ± NA-37.5 ± 40.31
PrimaryChange From Baseline in Hematology Parameter of Hemoglobin at Week 24

Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

Time frame:
Baseline (Day 01) and Week 24
Reported as:
Mean · Gram Per Liter (g/L)
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24
Gram Per Liter (g/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Hemoglobin at Week 240.4 ± 10.100.3 ± 9.89
PrimaryChange From Baseline in Hematology Parameter of Hemoglobin at Week 48

Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

Time frame:
Baseline (Day 01) and Week 48
Reported as:
Mean · Gram Per Liter (g/L)
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48
Gram Per Liter (g/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48-0.5 ± 10.38-1.1 ± 10.62
PrimaryChange From Baseline in Hematology Parameter of Hemoglobin at Week 96

Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

Time frame:
Baseline (Day 01) and Week 96
Reported as:
Mean · Gram Per Liter (g/L)
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96
Gram Per Liter (g/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Hemoglobin at Week 961.0 ± 11.371.2 ± 10.24
PrimaryChange From Baseline in Hematology Parameter of Hemoglobin at Week 144

Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

Time frame:
Baseline (Day 01) and Week 144
Reported as:
Mean · Gram Per Liter (g/L)
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144
Gram Per Liter (g/L)Otilimab 90 mgOtilimab 150 mg
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144-1.0 ± NA2.0 ± 2.83
PrimaryChange From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24

Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

Time frame:
Baseline (Day 01) and Week 24
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Neutrophils-0.348 ± 2.18-0.390 ± 2.13
Lymphocytes-0.001 ± 0.55-0.012 ± 0.55
Monocytes0.003 ± 0.180.00 ± 0.194
Eosinophils0.027 ± 0.16230.022 ± 0.171
Basophils-0.001 ± 0.0405-0.001 ± 0.04
Total WBC-0.32 ± 2.212-0.38 ± 2.230
PrimaryChange From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48

Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

Time frame:
Baseline (Day 01) and Week 48
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Neutrophils-0.318 ± 2.2215-0.541 ± 2.1426
Lymphocytes-0.022 ± 0.5385-0.051 ± 0.5725
Monocytes-0.002 ± 0.1871-0.013 ± 0.2461
Eosinophils0.018 ± 0.14350.028 ± 0.1844
Basophils-0.004 ± 0.0391-0.006 ± 0.0403
Total WBC-0.33 ± 2.283-0.58 ± 2.262
PrimaryChange From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96

Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

Time frame:
Baseline (Day 01) and Week 96
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Neutrophils-0.243 ± 1.8851-0.582 ± 2.4346
Lymphocytes0.090 ± 0.64530.018 ± 0.5816
Monocytes-0.042 ± 0.2001-0.001 ± 0.2035
Eosinophils0.025 ± 0.17250.029 ± 0.1526
Basophils-0.007 ± 0.0423-0.013 ± 0.0346
Total WBC-0.18 ± 2.043-0.53 ± 2.568
PrimaryChange From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144

Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

Time frame:
Baseline (Day 01) and Week 144
Reported as:
Mean · Giga cells per liter (10^9 cells/L)
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144
Giga cells per liter (10^9 cells/L)Otilimab 90 mgOtilimab 150 mg
Neutrophils-0.360 ± NA-0.935 ± 0.6718
Lymphocytes-0.320 ± NA0.010 ± 0.3253
Monocytes-0.220 ± NA0.010 ± 0.0424
Eosinophils-0.130 ± NA—
Basophils0.000 ± NA0.000 ± 0.0141
Total WBC-1.00 ± NA-0.85 ± 1.061
PrimaryChange From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Time frame:
Baseline (Day 01) and Week 24
Reported as:
Mean · International units per liter (IU/L)
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24
International units per liter (IU/L)Otilimab 90 mgOtilimab 150 mg
Aspartate Aminotransferase (AST)1.0 ± 11.090.8 ± 9.70
Alanine Aminotransferase (ALT)0.0 ± 15.80-0.1 ± 15.20
Alkaline Phosphatase (AP)3.0 ± 18.853.1 ± 21.05
Gamma Glutamyl Transferase (GGT)-0.9 ± 20.32-0.4 ± 18.94
Creatine Kinase (CPK)5.4 ± 103.03-3.8 ± 66.66
PrimaryChange From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Time frame:
Baseline (Day 01) and Week 48
Reported as:
Mean · International units per liter (IU/L)
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48
International units per liter (IU/L)Otilimab 90 mgOtilimab 150 mg
Aspartate Aminotransferase (AST)0.4 ± 11.110.4 ± 11.32
Alanine Aminotransferase (ALT)-0.9 ± 16.35-1.2 ± 16.26
Alkaline Phosphatase (AP)5.4 ± 20.075.2 ± 21.32
Gamma Glutamyl Transferase (GGT)-0.0 ± 22.44-0.4 ± 22.14
Creatine Kinase (CPK)7.8 ± 153.24-3.7 ± 71.52
PrimaryChange From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Time frame:
Baseline (Day 01) and Week 96
Reported as:
Mean · International units per liter (IU/L)
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96
International units per liter (IU/L)Otilimab 90 mgOtilimab 150 mg
Aspartate Aminotransferase (AST)0.1 ± 11.652.0 ± 7.47
Alanine Aminotransferase (ALT)-2.4 ± 19.02-1.1 ± 9.33
Alkaline Phosphatase (AP)0.0 ± 18.988.6 ± 27.79
Gamma Glutamyl Transferase (GGT)-1.9 ± 18.52-0.1 ± 19.67
Creatine Kinase (CPK)1.4 ± 39.733.6 ± 93.29
PrimaryChange From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Time frame:
Baseline (Day 01) and Week 144
Reported as:
Mean · International units per liter (IU/L)
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144
International units per liter (IU/L)Otilimab 90 mgOtilimab 150 mg
Aspartate Aminotransferase (AST)-8.0 ± NA2.0 ± 0.0
Alanine Aminotransferase (ALT)-14.0 ± NA—
Alkaline Phosphatase (AP)39.0 ± NA-1.5 ± 6.36
Gamma Glutamyl Transferase (GGT)-21.0 ± NA5.0 ± 14.14
Creatine Kinase (CPK)-47.0 ± NA-2.5 ± 31.82
PrimaryChange From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24

Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

Time frame:
Baseline (Day 01) and Week 24
Reported as:
Mean · Millimoles per liter (mmol/L)
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24
Millimoles per liter (mmol/L)Otilimab 90 mgOtilimab 150 mg
Cholesterol-0.038 ± 0.8542-0.011 ± 0.9685
HDL Cholesterol, Direct-0.020 ± 0.2703-0.022 ± 0.2869
LDL Cholesterol-0.031 ± 0.72390.010 ± 0.7818
Triglycerides0.033 ± 0.65030.011 ± 0.7895
PrimaryChange From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48

Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

Time frame:
Baseline (Day 01) and Week 48
Reported as:
Mean · Millimoles per liter (mmol/L)
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48
Millimoles per liter (mmol/L)Otilimab 90 mgOtilimab 150 mg
Cholesterol-0.053 ± 0.9271-0.078 ± 0.9826
HDL Cholesterol, Direct-0.021 ± 0.2979-0.027 ± 0.2959
LDL Cholesterol-0.038 ± 0.7865-0.034 ± 0.7899
Triglycerides0.015 ± 0.6772-0.019 ± 0.7376
PrimaryChange From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96

Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

Time frame:
Baseline (Day 01) and Week 96
Reported as:
Mean · Millimoles per liter (mmol/L)
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96
Millimoles per liter (mmol/L)Otilimab 90 mgOtilimab 150 mg
Cholesterol-0.178 ± 1.0350-0.130 ± 1.0570
HDL Cholesterol, Direct-0.032 ± 0.2665-0.058 ± 0.3233
LDL Cholesterol-0.159 ± 0.8948-0.031 ± 0.8546
Triglycerides0.009 ± 0.8042-0.056 ± 0.7262
PrimaryChange From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144

Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

Time frame:
Baseline (Day 01) and Week 144
Reported as:
Mean · Millimoles per liter (mmol/L)
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144
Millimoles per liter (mmol/L)Otilimab 90 mgOtilimab 150 mg
Cholesterol-2.360 ± NA-2.240 ± 2.8709
HDL Cholesterol, Direct0.160 ± NA-0.095 ± 0.0212
LDL Cholesterol-2.250 ± NA-1.750 ± 2.4183
Triglycerides-0.580 ± NA-0.865 ± 0.9687
PrimaryNumber of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities

Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.

Time frame:
Up to approximately 145 Weeks
Reported as:
Count of participants · Participants
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities
ParticipantsOtilimab 90 mgOtilimab 150 mg
Hypercalcemia, Total, Grade 310
Hyperkalemia, Total, Grade 420
Hypernatremia, Total, Grade 310
Hypernatremia, Total, Grade 401
Chronic Kidney Disease, Total, Grade 301
Creatinine increased, Total, Grade 310
SecondaryPercentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Percentage values are rounded off.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144
Percentage of participantsOtilimab 90 mgOtilimab 150 mg
Week 2447.046.0
Week 4844.047.0
Week 9640.047.0
Week 144—0.0
SecondaryPercentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144
Percentage of participantsOtilimab 90 mgOtilimab 150 mg
Week 2411.010.0
Week 4812.09.0
Week 9613.09.0
Week 144—0.0
SecondaryPercentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144
Percentage of participantsOtilimab 90 mgOtilimab 150 mg
Week 2426.025.0
Week 4825.025.0
Week 9626.028.0
Week 144—0.0
SecondaryPercentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132

The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.

Time frame:
Week 24, 48, 96 and 132
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132
Percentage of participantsOtilimab 90 mgOtilimab 150 mg
Week 2415.014.0
Week 4814.013.0
Week 9616.012.0
Week 1320.033.0
SecondaryPercentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI \<= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144
Percentage of participantsOtilimab 90 mgOtilimab 150 mg
Boolean-based ACR/EULAR, Week 247.06.0
Boolean-based ACR/EULAR, Week 488.04.0
Boolean-based ACR/EULAR, Week 968.09.0
Boolean-based ACR/EULAR, Week 144—0.0
SecondaryAbsolute Values for Clinical Disease Activity Index (CDAI) Total Score

CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · Scores on a scale
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 2413.42 ± 10.66914.26 ± 11.637
Week 4813.85 ± 10.61214.07 ± 11.186
Week 9614.62 ± 11.44315.22 ± 13.997
Week 144—11.30 ± NA
SecondaryAbsolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · Scores on a scale
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 243.49 ± 1.2373.55 ± 1.269
Week 483.51 ± 1.2243.54 ± 1.232
Week 963.44 ± 1.1883.52 ± 1.389
Week 144—3.21 ± NA
SecondaryAbsolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

Time frame:
Week 24, 48, 96 and 132
Reported as:
Mean · Scores on a scale
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 243.97 ± 1.2954.01 ± 1.333
Week 484.02 ± 1.2844.05 ± 1.306
Week 963.92 ± 1.2164.04 ± 1.470
Week 1323.77 ± NA4.26 ± 1.560
SecondaryAbsolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)

Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity.

Time frame:
Week 24 and 48
Reported as:
Mean · Scores on a scale
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 2423.26 ± 34.19130.31 ± 40.236
Week 4823.27 ± 33.95330.34 ± 40.432
SecondaryAbsolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)

The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · Scores on a scale
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 241.045 ± 0.67641.060 ± 0.6849
Week 481.072 ± 0.66791.096 ± 0.6691
Week 961.074 ± 0.68521.156 ± 0.7582
Week 144—2.00 ± NA
SecondaryAbsolute Values for Arthritis Pain Visual Analogue Scale (VAS)

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · Scores on a scale
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 2434.6 ± 23.5136.6 ± 23.85
Week 4837.0 ± 23.5536.0 ± 23.88
Week 9639.3 ± 24.6238.1 ± 27.08
Week 144—26.0 ± NA
SecondaryAbsolute Values Short Form (SF)-36 Mental Component Scores (MCS)

SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · T-score
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)
T-scoreOtilimab 90 mgOtilimab 150 mg
Week 2449.14 ± 10.38649.44 ± 10.384
Week 4849.54 ± 10.57749.70 ± 10.557
Week 9648.66 ± 11.48349.75 ± 11.351
Week 144—42.55 ± NA
SecondaryAbsolute Values SF-36 Domain Scores

Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · Scores on a scale
Absolute Values SF-36 Domain Scores
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Bodily Pain at Week 2454.49 ± 21.45753.83 ± 21.158
Bodily Pain at Week 4852.22 ± 21.09952.94 ± 21.158
Bodily Pain at Week 9649.90 ± 20.94351.11 ± 21.983
Bodily Pain at Week 144—41.00 ± NA
General Health at week 2451.00 ± 18.74450.30 ± 17.980
General Health at week 4850.35 ± 18.81749.44 ± 17.645
General Health at week 9648.44 ± 20.02946.73 ± 18.543
General Health at week 144—45.00 ± NA
Mental Health at week 2467.47 ± 19.38768.05 ± 19.150
Mental Health at week 4867.64 ± 19.70167.97 ± 19.636
Mental Health at week 9666.90 ± 20.86068.49 ± 20.217
Mental Health at week 144—50.00 ± NA
Physical Function at week 2456.20 ± 25.64455.28 ± 25.615
Physical Function at week 4854.23 ± 26.22253.98 ± 25.397
Physical Function at week 9651.87 ± 25.73550.92 ± 26.175
Physical Function at week 144—35.00 ± NA
Role Emotional At week 2474.79 ± 24.65375.09 ± 24.760
Role Emotional At week 4875.31 ± 24.00876.18 ± 24.163
Role Emotional At week 9673.35 ± 25.18874.44 ± 26.324
Role Emotional At week 144—50.00 ± NA
Role Physical at week 2458.58 ± 23.15557.78 ± 23.514
Role Physical at week 4856.49 ± 23.64557.57 ± 23.463
Role Physical at week 9654.27 ± 23.81855.15 ± 24.956
Role Physical at week 144—25.00 ± NA
Social Function at week 2471.20 ± 24.00171.39 ± 23.936
Social Function at week 4870.88 ± 24.59671.29 ± 24.123
Social Function at week 9668.25 ± 24.06569.43 ± 26.526
Social Function at week 144—62.50 ± NA
Vitality at week 2455.77 ± 20.69055.18 ± 20.593
Vitality at week 4855.24 ± 20.97254.49 ± 21.262
Vitality at week 9651.04 ± 23.12754.25 ± 22.738
Vitality at week 144—50.00 ± NA
SecondaryAbsolute Values SF-36 Physical Component Scores (PCS)

SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · T-Score
Absolute Values SF-36 Physical Component Scores (PCS)
T-ScoreOtilimab 90 mgOtilimab 150 mg
Week 2441.19 ± 8.17340.67 ± 8.232
Week 4840.17 ± 8.58640.13 ± 8.271
Week 9639.18 ± 9.28038.86 ± 8.879
Week 144—35.03 ± NA
SecondaryAbsolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life.

Time frame:
Week 24, 48, 96 and 144
Reported as:
Mean · Scores on a scale
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Scores on a scaleOtilimab 90 mgOtilimab 150 mg
Week 2436.0 ± 10.3335.9 ± 10.25
Week 4835.5 ± 10.5335.4 ± 10.59
Week 9635.2 ± 10.7734.8 ± 11.87
Week 144—26.0 ± NA
SecondaryNumber of Participants With Anti-GSK3196165 Antibodies

Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA

Time frame:
Week 120
Reported as:
Count of participants · Participants
Number of Participants With Anti-GSK3196165 Antibodies
ParticipantsOtilimab 90 mgOtilimab 150 mg
Number of Participants With Anti-GSK3196165 Antibodies1110
PrimaryChange From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Time frame:
Baseline (Day 01) and Week 24
Reported as:
Mean · Micromoles per liter (umol/L)
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Micromoles per liter (umol/L)Otilimab 90 mgOtilimab 150 mg
Total Bilirubin0.3 ± 2.870.3 ± 2.92
Direct Bilirubin0.053 ± 0.7640.027 ± 0.641
PrimaryChange From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Time frame:
Baseline (Day 01) and Week 48
Reported as:
Mean · Micromoles per liter (umol/L)
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
Micromoles per liter (umol/L)Otilimab 90 mgOtilimab 150 mg
Total Bilirubin-0.0 ± 2.850.1 ± 3.04
Direct Bilirubin0.011 ± 0.7770.040 ± 0.690
PrimaryChange From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Time frame:
Baseline (Day 01) and Week 96
Reported as:
Mean · Micromoles per liter (umol/L)
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96
Micromoles per liter (umol/L)Otilimab 90 mgOtilimab 150 mg
Total Bilirubin-0.2 ± 3.220.5 ± 3.49
Direct Bilirubin0.047 ± 0.8150.041 ± 0.827
PrimaryChange From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Time frame:
Baseline (Day 01) and Week 144
Reported as:
Mean · Micromoles per liter (umol/L)
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Micromoles per liter (umol/L)Otilimab 90 mgOtilimab 150 mg
Total Bilirubin4.0 ± NA4.5 ± 6.36
Direct Bilirubin2.000 ± NA1.500 ± 0.707

Adverse events

Collected over All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Otilimab 90 mg10/1,456 (0.7%)123/1,456 (8.4%)279/1,456 (19.2%)
Otilimab 150 mg9/1,459 (0.6%)114/1,459 (7.8%)308/1,459 (21.1%)
Most frequent serious events
Showing 10 of 187
Most frequent serious events
EventOtilimab 90 mgOtilimab 150 mg
COVID-19 pneumoniaInfections and infestations8/145610/1459
OsteoarthritisMusculoskeletal and connective tissue disorders6/14568/1459
Rheumatoid arthritisMusculoskeletal and connective tissue disorders7/14564/1459
PneumoniaInfections and infestations5/14565/1459
COVID-19Infections and infestations4/14561/1459
Acute myocardial infarctionCardiac disorders3/14563/1459
Myocardial infarctionCardiac disorders3/14562/1459
CellulitisInfections and infestations3/14560/1459
Femoral neck fractureInjury, poisoning and procedural complications1/14563/1459
Femur fractureInjury, poisoning and procedural complications0/14563/1459
Most frequent other events
Most frequent other events
EventOtilimab 90 mgOtilimab 150 mg
COVID-19Infections and infestations141/1456141/1459
Rheumatoid arthritisMusculoskeletal and connective tissue disorders118/1456129/1459
Upper respiratory tract infectionInfections and infestations65/145688/1459

Baseline characteristics

One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=1459).

Age, Continuous
Age, Continuous(YEARS)Otilimab 90 mgOtilimab 150 mgTotal
Mean55.2 ± 11.3855.7 ± 10.9155.4 ± 11.15
Sex: Female, Male
Sex: Female, Male(Participants)Otilimab 90 mgOtilimab 150 mgTotal
Female115811812339
Male298278576
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Otilimab 90 mgOtilimab 150 mgTotal
AMERICAN INDIAN OR ALASKA NATIVE405393
ASIAN223206429
BLACK OR AFRICAN AMERICAN332861
WHITE114711572304
MULTIPLE131528
08

Study locations

377 sites
  • GSK Investigational Site
    Anniston, Alabama 36207, United States
  • GSK Investigational Site
    Flagstaff, Arizona 86001, United States
  • GSK Investigational Site
    Gilbert, Arizona 85297, United States
  • GSK Investigational Site
    Glendale, Arizona 85306, United States
  • GSK Investigational Site
    Mesa, Arizona 85210, United States
  • GSK Investigational Site
    Phoenix, Arizona 85032, United States
  • GSK Investigational Site
    Phoenix, Arizona 85037, United States
  • GSK Investigational Site
    Tucson, Arizona 85704, United States
  • GSK Investigational Site
    Covina, California 91722, United States
  • GSK Investigational Site
    Poway, California 92064, United States
  • GSK Investigational Site
    San Diego, California 92108, United States
  • GSK Investigational Site
    San Diego, California 92128, United States
  • GSK Investigational Site
    Upland, California 91786, United States
  • GSK Investigational Site
    Van Nuys, California 91405, United States
  • GSK Investigational Site
    Whittier, California 90602, United States
  • GSK Investigational Site
    Denver, Colorado 80230, United States
  • GSK Investigational Site
    Fort Collins, Colorado 80528, United States
  • GSK Investigational Site
    Aventura, Florida 33180, United States
  • GSK Investigational Site
    Brandon, Florida 33511, United States
  • GSK Investigational Site
    Clearwater, Florida 33765, United States
  • GSK Investigational Site
    Daytona Beach, Florida 32117, United States
  • GSK Investigational Site
    Jacksonville, Florida 32207, United States
  • GSK Investigational Site
    Miami Lakes, Florida 33014, United States
  • GSK Investigational Site
    Miami Lakes, Florida 33016, United States
  • GSK Investigational Site
    Miami, Florida 33134, United States
  • GSK Investigational Site
    Miami, Florida 33155, United States
  • GSK Investigational Site
    Miami, Florida 33165, United States
  • GSK Investigational Site
    Miami, Florida 33173, United States
  • GSK Investigational Site
    New Port Richey, Florida 34652, United States
  • GSK Investigational Site
    Orlando, Florida 32835, United States
  • GSK Investigational Site
    Palmetto Bay, Florida 33157, United States
  • GSK Investigational Site
    Tamarac, Florida 33321, United States
  • GSK Investigational Site
    Tampa, Florida 33603, United States
  • GSK Investigational Site
    Tampa, Florida 33614, United States
  • GSK Investigational Site
    Atlanta, Georgia 30318, United States
  • GSK Investigational Site
    Marietta, Georgia 30060, United States
  • GSK Investigational Site
    Idaho Falls, Idaho 83404, United States
  • GSK Investigational Site
    Skokie, Illinois 60076, United States
  • GSK Investigational Site
    Evansville, Indiana 47715, United States
  • GSK Investigational Site
    Wichita, Kansas 67207, United States
  • GSK Investigational Site
    Bowling Green, Kentucky 42101, United States
  • GSK Investigational Site
    Lake Charles, Louisiana 70601, United States
  • GSK Investigational Site
    Monroe, Louisiana 71203, United States
  • GSK Investigational Site
    Wheaton, Maryland 20902, United States
  • GSK Investigational Site
    Grand Blanc, Michigan 48439, United States
  • GSK Investigational Site
    Lansing, Michigan 48910, United States
  • GSK Investigational Site
    Novi, Michigan 48375, United States
  • GSK Investigational Site
    Saint Louis, Missouri 63141, United States
  • GSK Investigational Site
    Lincoln, Nebraska 68516, United States
  • GSK Investigational Site
    Lebanon, New Hampshire 03756, United States
  • GSK Investigational Site
    Freehold, New Jersey 07728, United States
  • GSK Investigational Site
    Brooklyn, New York 11201, United States
  • GSK Investigational Site
    Fayetteville, North Carolina 30214, United States
  • GSK Investigational Site
    Greensboro, North Carolina 27408, United States
  • GSK Investigational Site
    Minot, North Dakota 58701, United States
  • GSK Investigational Site
    Cincinnati, Ohio 45242, United States
  • GSK Investigational Site
    Vandalia, Ohio 45377, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73103, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73104, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73112, United States
  • GSK Investigational Site
    Yukon, Oklahoma 73099, United States
  • GSK Investigational Site
    Greenville, South Carolina 29601, United States
  • GSK Investigational Site
    Summerville, South Carolina 29486, United States
  • GSK Investigational Site
    Amarillo, Texas 79124, United States
  • GSK Investigational Site
    Austin, Texas 78731, United States
  • GSK Investigational Site
    Austin, Texas 78745, United States
  • GSK Investigational Site
    Baytown, Texas 77521, United States
  • GSK Investigational Site
    Colleyville, Texas 76034, United States
  • GSK Investigational Site
    Dallas, Texas 75231, United States
  • GSK Investigational Site
    Houston, Texas 77065, United States
  • GSK Investigational Site
    Houston, Texas 77084, United States
  • GSK Investigational Site
    Houston, Texas 77089, United States
  • GSK Investigational Site
    Houston, Texas 77090, United States
  • GSK Investigational Site
    Lubbock, Texas 79410, United States
  • GSK Investigational Site
    Plano, Texas 75024, United States
  • GSK Investigational Site
    The Woodlands, Texas 77382, United States
  • GSK Investigational Site
    Tomball, Texas 77375, United States
  • GSK Investigational Site
    Waco, Texas 76710, United States
  • GSK Investigational Site
    Glendale, Wisconsin 53217, United States
  • GSK Investigational Site
    Ciudad Autonoma Buenos aires, Buenos Aires C1046AAQ, Argentina
  • GSK Investigational Site
    Ciudad Autonoma Buenos Aires, Buenos Aires C1114ABH, Argentina
  • GSK Investigational Site
    Ciudad Autonoma Buenos Aires, Buenos Aires C1417, Argentina
  • GSK Investigational Site
    Ciudad Autonoma Buenos Aires, Buenos Aires C1430EGF, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires 1426, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO, Argentina
  • GSK Investigational Site
    La Palta, Buenos Aires B1900AXI, Argentina
  • GSK Investigational Site
    Mar del Plata, Buenos Aires B7600FYK, Argentina
  • GSK Investigational Site
    Quilmes, Buenos Aires B1878GEG, Argentina
  • GSK Investigational Site
    San Isidro, Buenos Aires 1643, Argentina
  • GSK Investigational Site
    San Nicolas, Buenos Aires B2900DMH, Argentina
  • GSK Investigational Site
    Cordoba, Córdova X5003DCE, Argentina
  • GSK Investigational Site
    Rosario, Santa Fe S2000DSV, Argentina
  • GSK Investigational Site
    San Miguel de Tucuman, Tucumán T4000AXL, Argentina
  • GSK Investigational Site
    San Miguel de Tucumán, Tucumán T4000BRD, Argentina
  • GSK Investigational Site
    Buenos Aires, C1430CKE, Argentina
  • GSK Investigational Site
    Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
  • GSK Investigational Site
    Ciudad Autónoma de Buenos Aires, C1426BOR, Argentina
  • GSK Investigational Site
    Cordoba, 5000, Argentina
  • GSK Investigational Site
    Nueva Cordoba, X5000AVE, Argentina

Showing the first 100 of 377 sites across 27 countries.

09

References and documents

Study documents

  • Study protocol · Oct 14, 2019
  • Statistical analysis plan · Jan 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04333147
Lead sponsor
GlaxoSmithKline
Collaborators
Iqvia Pty Ltd
Responsible party
Sponsor
First posted
Apr 3, 2020
Start date
May 12, 2020
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023
Results posted
Feb 7, 2024
Last update
Feb 7, 2024

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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