A Phase 2 interventional study of Lutikizumab and Placebo in Rheumatoid Arthritis, sponsored by AbbVie. Recruiting at 96 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
Substudy 4: Double-Blind Treatment Period · Substudy 4: Long Term Open-Label Extension Period · Substudy 5: Double-Blind Treatment Period · Substudy 5: Long Term Open-Label Extension Period · Substudy 6: Double-Blind Treatment Period 1 · Substudy 6: Open-Label Extension Period 2
Among 46 studies in Arthritis, Rheumatoid by AbbVie — 4 open to participants now, 5 under way, 1 of them phase 3. Arthritis, Rheumatoid · AbbVie.
Among the 46 studies in Arthritis, Rheumatoid by AbbVie, this one is the 17th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2025, is one of 11 in phase 2, and was the 44th registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
Browse Arthritis, Rheumatoid studies →4 of the 46 studies in Arthritis, Rheumatoid by AbbVie are open now, in 12 countries. Recruiting first, the newest first:
AbbVie · Sites in United States, Japan
Ages 18–75
AbbVie · Sites in Germany
Ages 18+
AbbVie
Ages 18+
By country, each count listing its studies:
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 12 · Phase 3 9 · Phase 4 1
First in 2007; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 250 across the 25 interventional studies, 166 across the 20 observational. Of the 38 that completed or were terminated, 24 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
1 of the studies in Arthritis, Rheumatoid by AbbVie that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06972446AbbVieA Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis | 2027-02 |
Among the 46 studies in Arthritis, Rheumatoid by AbbVie, from their registry updates:
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Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).
This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
The criteria were revised on the registry on Oct 8, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B
Drug: Lutikizumab
Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.
Drug: Placebo
Participants will be randomized to receive Ravagalimab
Drug: Ravagalimab
Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy
Drug: Placebo
Participants will be randomized to be administered Lutikizumab and Ravagalimab doses
Drug: Lutikizumab · Drug: Ravagalimab
Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy
Drug: Placebo
Subcutaneous (SC) injection
Subcutaneous (SC) injection
Subcutaneous (SC) injection
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: At Week 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately Week 22
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: At Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: At Week 12
Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). LDA is defined as a score of \< or = to 3.2.
Time frame: At Week 12
Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). CR remission is defined as a score of less than 2.6
Time frame: At Week 12
Change from Baseline in DAS28 (CRP)
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Time frame: At Week 12
Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI)
The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. LDA is defined as a score from 2.8 to ≤ 10.
Time frame: At Week 12
Percentage Of Participants Achieving CR per CDAI
The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. CR remission is defined as a score of less than 2.8
Time frame: At Week 12
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Feb 2027, 20 months after the start.
Of 116 industry-sponsored phase 2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 24. This study's planned 20 months is above that.
Counting every sponsor, half of 158 studies reached it within 18 months; a quarter within 13 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
Substudy 4: Double-Blind Treatment Period · Substudy 4: Long Term Open-Label Extension Period · Substudy 5: Double-Blind Treatment Period · Substudy 5: Long Term Open-Label Extension Period · Substudy 6: Double-Blind Treatment Period 1 · Substudy 6: Open-Label Extension Period 2
Substudy 4: Double-Blind Treatment Period · Substudy 4: Long Term Open-Label Extension Period · Substudy 5: Double-Blind Treatment Period · Substudy 5: Long Term Open-Label Extension Period · Substudy 6: Double-Blind Treatment Period 1 · Substudy 6: Open-Label Extension Period 2
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Lutikizumab · Ravagalimab