Targeted Therapies for Rheumatoid Arthritis

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must be taking: Methotrexate

Disqualifiers: Juvenile arthritis, Other joint diseases

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people with moderately to severely active Rheumatoid Arthritis who have tried at least one but no more than two biologic/targeted synthetic DMARD therapies without success or had to stop due to side effects. They must be on a stable dose of methotrexate.

Inclusion Criteria

I have taken 1 or 2 types of advanced RA medications for at least 3 months but still have active symptoms or had to stop due to side effects.

I am on a stable dose of methotrexate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted therapies, including lutikizumab and ravagalimab, in various substudies

12 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lutikizumab
• Placebo
• Ravagalimab

Trial Overview The study tests the effectiveness and safety of Lutikizumab and Ravagalimab, alone or combined, against a placebo. It includes three substudies: Lutikizumab vs. placebo, Ravagalimab vs. placebo, and both drugs combined vs. placebo in patients who've failed previous treatments.

How Is the Trial Designed?

Group I: Substudy 2: Ravagalimab Monotherapy Experimental Treatment 1 Intervention

Participants will be randomized to receive Ravagalimab

Group II: Substudy 1: Lutikizumab Monotherapy Experimental Treatment 1 Intervention

Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B

Group III: SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy Experimental Treatment 2 Interventions

Participants will be randomized to be administered Lutikizumab and Ravagalimab doses

Group IV: Substudy 1: Matching Placebo Monotherapy Placebo Group 1 Intervention

Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.

Group V: Substudy 2: Matching Placebo Monotherapy Placebo Group 1 Intervention

Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy

Group VI: Substudy 3: Matching Placebo Combination Therapy Placebo Group 1 Intervention

Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois