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A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

NCT06972446 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-22

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Lutikizumab

Subcutaneous (SC) injection

DRUG

Placebo

Subcutaneous (SC) injection

DRUG

Ravagalimab

Subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2027-02-28
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Puerto Rico
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06972446 on ClinicalTrials.gov