Clinical trial NCT06972446: A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
Official title: A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab 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 (b/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.


Eligibility criteria: Inclusion Criteria:

* At any time prior to the Screening Visit, participant must have been treated for \> or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
* Participant must be on a stable dose of methotrexate (MTX)

Exclusion Criteria:

* Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: At Week 12
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately Week 22
Secondary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: At Week 12
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: At Week 12
measure: Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
timeFrame: At Week 12
measure: Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)
timeFrame: At Week 12
measure: Change from Baseline in DAS28 (CRP)
timeFrame: At Week 12
measure: Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI)
timeFrame: At Week 12
measure: Percentage Of Participants Achieving CR per CDAI
timeFrame: At Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: