Rosnilimab for Rheumatoid Arthritis

Recruiting at 147 trial locations

Overseen By AnaptysBio Clinical Trial Inbox

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AnaptysBio, Inc.

Must be taking: csDMARDs

Must not be taking: PD-1, PD-L1

Disqualifiers: Inflammatory joint disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must continue taking at least one, but not more than two, csDMARDs (a type of medication for rheumatoid arthritis) at stable dosages throughout the trial.

What is the purpose of this trial?

This trial is testing Rosnilimab, a new medication, to see if it can help people with moderate to severe rheumatoid arthritis by reducing joint pain and swelling. The study will check if the medication is safe and effective.

Eligibility Criteria

This trial is for adults with moderate to severe Rheumatoid Arthritis who have been diagnosed at least 3 months prior and are currently on stable doses of up to two conventional synthetic DMARDs. It's not open to pregnant or breastfeeding women, those with other joint diseases, previous PD-1/PD-L1 treatment, recent cancer history, or compromised immune systems.

Inclusion Criteria

I have been on 1 or 2 standard arthritis drugs for at least 3 months.

I have been diagnosed with Rheumatoid Arthritis for at least 3 months.

Exclusion Criteria

I do not have any conditions that weaken my immune system.

I have a history of an inflammatory joint disease that is not Rheumatoid Arthritis.

I have been treated with a PD-1 or PD-L1 inhibitor before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rosnilimab or placebo subcutaneously for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ANB030

Trial Overview The RENOIR study is testing the safety and effectiveness of Rosnilimab compared to a placebo in treating Rheumatoid Arthritis. Participants will randomly receive either Rosnilimab or a placebo alongside their standard treatments.

Participant Groups

Group I: Rosnilimab SC Dose 3 Experimental Treatment 1 Intervention

This arm will receive treatment SC

Group II: Rosnilimab SC Dose 2 Experimental Treatment 1 Intervention

This arm will receive treatment SC

Group III: Rosnilimab SC Dose 1 Experimental Treatment 1 Intervention

This arm will receive treatment SC

Group IV: Placebo Placebo Group 1 Intervention

This arm will receive Placebo

Who Is Running the Clinical Trial?

AnaptysBio, Inc.

Lead Sponsor

Trials

17

Recruited

1,700+