A Phase 3 interventional study of AIN457 6 mg/kg i.v. and Placebo in Psoriatic Arthritis, sponsored by Novartis Pharmaceuticals. Completed at 81 sites in 15 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.
This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening (SCR) period running up to 10 weeks before randomization was used to assess subject eligibility followed by a treatment period of 52 weeks.
At baseline, 381 patients with active psoriatic arthritis were randomized to one of the two treatment groups in a 1:1 randomization:
Group 1: Approximately 190 patients with active psoriatic arthritis; These patients received secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4.
Group 2: Approximately 190 patients with active psoriatic arthritis; These patients received i.v. placebo at BSL and at Weeks 4, 8, and 12, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 16.
Study consisted of 4 periods: a screening period (up to 10 weeks), treatment period 1 (total duration of 16 weeks) and treatment period 2 (total duration of 36 weeks) followed by a safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52).
Primary endpoint analysis will be performed with Week 16 data (last patient completing Treatment period 1 (Week 16). Long-term efficacy and safety assessments will be performed up to Week 52.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 381 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients eligible for inclusion in this study had to fulfill all of the following criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
Drug: AIN457 6 mg/kg i.v. · Drug: AIN457 3 mg/kg
Matching placebo from baseline to Week 16 and switch to AIN457 3mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).
Drug: Placebo
AIN457 6 mg/kg delivered by i.v. infusion
Also known as: secukinumab
Matching placebo to AIN457 i.v. infusion
AIN457 3 mg/kg delivered by i.v. infusion
Also known as: secukinumab
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set)
Percentage of participants with active psoriatic arthritis (PsA) who achieved an American College of Rheumatology 50 (ACR50) response The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
Time frame: Baseline up to Week 16
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)
Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.
Time frame: Baseline up to Week 16
Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)
MDA is assessed as 5 of the 7 following: ≤ 1 tender and swollen joint; entheseal count, PASI ≤ 1 or BSA ≤3%, PsA ≤ 15 and disease activity ≤ 20 (VAS) and HAQ-DI© ≤ 0.5
Time frame: Baseline up to Week 16
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set)
Change from baseline of a 90% reduction in the PASI score for patients with a \>= 3% body surface area psoriasis at baseline. Four body surface areas are evaluated (head, trunk and upper and lower limbs) for plaque, erythema, scaling and thickness. The degree of severity of each sign in each of the 4 body areas was assigned a score of 0 to 4. Scores ranged from 0 to 72 and higher scores represent worsening severity.
Time frame: Baseline up to Week 16
Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)
PASDAS is a composite measure developed to assess disease activity in Psoriatic arthritis. It is calculated by utilizing seven measures: Patient reported measures (excluding mental component) (SF-36-PCS), skin, peripheral joint counts (tender and swollen joint counts), dactylitis (LDI), enthesitis (LEI), acute phase response (CRP), and patient and physician global VAS scores. The typical score range is between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.
Time frame: Baseline up to Week 16
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
Time frame: Baseline up to Week 16
Short Form 36-Physical Component Summary (SF36-PCS) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)
The SF-36 is used to measure health-related quality of life with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Range of scoring is 0 -100, with higher scores indicating better health status.
Time frame: Baseline up to Week 16
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)
The FACIT-Fatigue is a 13 item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Response scale ranges from 0-4 and the total score range is 0 - 52. Higher scores indicate better quality of life
Time frame: Baseline up to Week 16
Modified Nail Psoriasis Severity Index (mNAPSI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)
The mNAPSI is an instrument to assess psoriatic nail involvement. Three groups of features (onycholysis and oil-drop dyshromia, pitting and crumbling) were graded on a scale from 0 to 3 for a total subscale of 0 to 9. The next 4 abnormalities (leukonychia, splinter hemorrhages, hyperkeratosis and red spots in the lunula) were graded as absent (0) or present (1) for a total subscale of 0 to 4. The total score was from 0-13 where higher scores represent worse nail disease.
Time frame: Baseline up to Week 16
Percentage of Participants With Complete Resolution of Dactylitis at Week 16 Using Non-responder Imputation (Dactylitis Subset)
Dactylitis is characterized by swelling of the entire finger or toe. The Leeds Dactylitis Index (LDI) measures the ratio of the circumference of the affected (swollen) digit. The ratio of circumference is multiplied by a tenderness score, using a modification of LDI that is a binary score (1 for tender, 0 for non-tender). The LDI requires a finger circumference gauge or a dactylometer to measure digital circumference. Scores range from 0 - 20 and lower score indicates better outcome.
Time frame: Baseline up to Week 16
Percentage of Participants With Complete Resolution of Enthesitis at Week 16 Using Non-responder Imputation (Enthesitis Subset (LEI))
Enthesitis is inflammation of the enthesis which is where a a tendon or ligament attaches to the bone. The Leeds enthesitis index (LEI) is a validated index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur L+R. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
Time frame: Baseline up to Week 16
| Milestone | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Started | 191 | 190 |
| Completed | 173 | 167 |
| Not completed | 18 | 23 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Subject decision | 10 | 10 |
| Withdrew: Progressive disease | 1 | 0 |
| Withdrew: Protocol deviation | 0 | 1 |
| Withdrew: New therapy for study indication | 1 | 0 |
| Withdrew: Adverse event - placebo not switched | 0 | 1 |
| Withdrew: Subject decision - placebo not switched | 0 | 5 |
| Withdrew: Death - placebo not switched | 0 | 1 |
Percentage of participants with active psoriatic arthritis (PsA) who achieved an American College of Rheumatology 50 (ACR50) response The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
| Percentage of participants | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Percentage of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set) | 31.35 (24.80 to 37.90) | 6.33 (2.87 to 9.79) |
Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.
| Percentage of participants | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | 59.60 (52.67 to 66.52) | 29.01 (22.57 to 35.44) |
MDA is assessed as 5 of the 7 following: ≤ 1 tender and swollen joint; entheseal count, PASI ≤ 1 or BSA ≤3%, PsA ≤ 15 and disease activity ≤ 20 (VAS) and HAQ-DI© ≤ 0.5
| Percentage of participants | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | 22.45 (16.57 to 28.33) | 5.28 (2.10 to 8.46) |
Change from baseline of a 90% reduction in the PASI score for patients with a \>= 3% body surface area psoriasis at baseline. Four body surface areas are evaluated (head, trunk and upper and lower limbs) for plaque, erythema, scaling and thickness. The degree of severity of each sign in each of the 4 body areas was assigned a score of 0 to 4. Scores ranged from 0 to 72 and higher scores represent worsening severity.
| Percentage of participants | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set) | 47.85 (38.15 to 57.54) | 6.46 (1.83 to 11.09) |
PASDAS is a composite measure developed to assess disease activity in Psoriatic arthritis. It is calculated by utilizing seven measures: Patient reported measures (excluding mental component) (SF-36-PCS), skin, peripheral joint counts (tender and swollen joint counts), dactylitis (LDI), enthesitis (LEI), acute phase response (CRP), and patient and physician global VAS scores. The typical score range is between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.
| scores on a scale | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | -2.24 ± 0.103 | -1.11 ± 0.103 |
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
| scores on a scale | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | -0.39 ± 0.035 | 0.15 ± 0.035 |
The SF-36 is used to measure health-related quality of life with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Range of scoring is 0 -100, with higher scores indicating better health status.
| scores on a scale | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Short Form 36-Physical Component Summary (SF36-PCS) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | 6.47 ± 0.558 | 2.34 ± 0.550 |
The FACIT-Fatigue is a 13 item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Response scale ranges from 0-4 and the total score range is 0 - 52. Higher scores indicate better quality of life
| scores on a scale | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | 6.15 ± 0.759 | 3.30 ± 0.750 |
The mNAPSI is an instrument to assess psoriatic nail involvement. Three groups of features (onycholysis and oil-drop dyshromia, pitting and crumbling) were graded on a scale from 0 to 3 for a total subscale of 0 to 9. The next 4 abnormalities (leukonychia, splinter hemorrhages, hyperkeratosis and red spots in the lunula) were graded as absent (0) or present (1) for a total subscale of 0 to 4. The total score was from 0-13 where higher scores represent worse nail disease.
| scores on a scale | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Modified Nail Psoriasis Severity Index (mNAPSI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | -9.25 ± 1.069 | -3.14 ± 1.084 |
Dactylitis is characterized by swelling of the entire finger or toe. The Leeds Dactylitis Index (LDI) measures the ratio of the circumference of the affected (swollen) digit. The ratio of circumference is multiplied by a tenderness score, using a modification of LDI that is a binary score (1 for tender, 0 for non-tender). The LDI requires a finger circumference gauge or a dactylometer to measure digital circumference. Scores range from 0 - 20 and lower score indicates better outcome.
| Percentage of participants | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Percentage of Participants With Complete Resolution of Dactylitis at Week 16 Using Non-responder Imputation (Dactylitis Subset) | 59.53 (48.96 to 70.11) | 32.05 (21.33 to 42.76) |
Enthesitis is inflammation of the enthesis which is where a a tendon or ligament attaches to the bone. The Leeds enthesitis index (LEI) is a validated index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur L+R. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
| Percentage of participants | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. |
|---|---|---|
| Percentage of Participants With Complete Resolution of Enthesitis at Week 16 Using Non-responder Imputation (Enthesitis Subset (LEI)) | 55.52 (46.92 to 64.12) | 39.16 (30.14 to 48.19) |
Collected over Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AIN457 6 mg/kg - 3 mg/kg i.v | 0/374 (0%) | 22/374 (5.9%) | 136/374 (36.4%) |
| Placebo up to Week 16 | 1/190 (0.5%) | 4/190 (2.1%) | 35/190 (18.4%) |
| Event | AIN457 6 mg/kg - 3 mg/kg i.v | Placebo up to Week 16 |
|---|---|---|
| COVID-19Infections and infestations | 6/374 | 0/190 |
| COVID-19 pneumoniaInfections and infestations | 2/374 | 2/190 |
| PneumoniaInfections and infestations | 2/374 | 0/190 |
| Cerebrovascular accidentNervous system disorders | 0/374 | 1/190 |
| Transient ischaemic attackNervous system disorders | 0/374 | 1/190 |
| AnaemiaBlood and lymphatic system disorders | 1/374 | 0/190 |
| Angina unstableCardiac disorders | 1/374 | 0/190 |
| Myocardial infarctionCardiac disorders | 1/374 | 0/190 |
| Ventricular tachycardiaCardiac disorders | 1/374 | 0/190 |
| VertigoEar and labyrinth disorders | 1/374 | 0/190 |
| Event | AIN457 6 mg/kg - 3 mg/kg i.v | Placebo up to Week 16 |
|---|---|---|
| COVID-19Infections and infestations | 37/374 | 7/190 |
| Urinary tract infectionInfections and infestations | 17/374 | 1/190 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 14/374 | 3/190 |
| NasopharyngitisInfections and infestations | 13/374 | 3/190 |
| Alanine aminotransferase increasedInvestigations | 12/374 | 4/190 |
| SARS-CoV-2 test positiveInvestigations | 12/374 | 2/190 |
| HeadacheNervous system disorders | 12/374 | 5/190 |
| HypertensionVascular disorders | 12/374 | 1/190 |
| Upper respiratory tract infectionInfections and infestations | 10/374 | 6/190 |
| NauseaGastrointestinal disorders | 11/374 | 2/190 |
Randomized set
| Age, Customized(Participants) | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. | Total |
|---|---|---|---|
| <65 years | 170 | 165 | 335 |
| 65-74 years | 17 | 24 | 41 |
| >= 75 years | 4 | 1 | 5 |
| Sex: Female, Male(Participants) | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. | Total |
|---|---|---|---|
| Female | 104 | 105 | 209 |
| Male | 87 | 85 | 172 |
| Race/Ethnicity, Customized(Participants) | AIN457 6 mg/kg - 3 mg/kg i.v. | Placebo to AIN457 3 mg/kg i.v. | Total |
|---|---|---|---|
| White | 148 | 153 | 301 |
| Black or African American | 5 | 1 | 6 |
| Asian | 25 | 26 | 51 |
| American Indian or Alaska Native | 10 | 9 | 19 |
| More than one race | 3 | 1 | 4 |
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Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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