420 Participants Needed

Rosnilimab for Rheumatoid Arthritis

Recruiting at 147 trial locations
AC
Overseen ByAnaptysBio Clinical Trial Inbox
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AnaptysBio, Inc.
Must be taking: csDMARDs
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

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.

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.
I am 18 years old or older.

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.
See 2 more

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 OverviewThe 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
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Rosnilimab SC Dose 3Experimental Treatment1 Intervention
This arm will receive treatment SC
Group II: Rosnilimab SC Dose 2Experimental Treatment1 Intervention
This arm will receive treatment SC
Group III: Rosnilimab SC Dose 1Experimental Treatment1 Intervention
This arm will receive treatment SC
Group IV: PlaceboPlacebo Group1 Intervention
This arm will receive Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

AnaptysBio, Inc.

Lead Sponsor

Trials
17
Recruited
1,700+