Rosnilimab for Rheumatoid Arthritis

Not currently recruiting at 156 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called Rosnilimab for individuals with moderate to severe Rheumatoid Arthritis (RA). Participants will receive varying doses of Rosnilimab or a placebo to evaluate the treatment's efficacy and tolerability. Ideal candidates have had RA for at least three months, are on a stable treatment plan with one or two RA medications, and have experienced inadequate results or issues with past treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to the development of potentially effective RA therapies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rosnilimab was well-tolerated in earlier studies. Few participants left the studies, and researchers found no major safety issues. Unlike some treatments for rheumatoid arthritis, such as JAK inhibitors, rosnilimab did not cause concerning side effects. This suggests that rosnilimab might be safe for those considering joining a clinical trial.12345

Why are researchers excited about this trial's treatment for RA?

Rosnilimab is unique because it targets a specific protein involved in the inflammatory process of rheumatoid arthritis, potentially offering a new mechanism of action compared to current treatments like methotrexate or biologics such as TNF inhibitors. Researchers are excited because Rosnilimab is administered subcutaneously, which might offer a more convenient and less invasive alternative to intravenous options. Additionally, Rosnilimab's ability to modulate the immune response differently could mean fewer side effects and improved outcomes for patients who don't respond well to existing therapies.

What evidence suggests that Rosnilimab could be an effective treatment for Rheumatoid Arthritis?

Research has shown that Rosnilimab, which participants in this trial may receive, may effectively treat rheumatoid arthritis (RA). In one study, patients experienced significant improvements, including symptom relief. Rosnilimab targets and reduces harmful T cells, which are part of the immune system and contribute to RA. Specifically, patients in that study demonstrated lasting improvements in their condition over time. Overall, Rosnilimab has proven effective and safe in these studies.12367

Are You a Good Fit for This Trial?

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.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Rosnilimab SC Dose 3Experimental Treatment1 Intervention
Group II: Rosnilimab SC Dose 2Experimental Treatment1 Intervention
Group III: Rosnilimab SC Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AnaptysBio, Inc.

Lead Sponsor

Trials
17
Recruited
1,700+

Citations

Anaptys Announces New Positive Phase 2b Trial Results ...New data reinforce rosnilimab's efficacy profile in rheumatoid arthritis (RA) with deepening of clinical responses, including CDAI remission ...
Rosnilimab, a Selective and Potent Depleter of Pathogenic ...Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells, Demonstrates Efficacy, Safety, and Translational Proof of Mechanism in a ...
Anaptys Announces Late-Breaking Oral Presentation of ...Anaptys Announces Late-Breaking Oral Presentation of Complete Phase 2b Data for Rosnilimab in Rheumatoid Arthritis at Upcoming ACR Convergence ...
Phase 2b data show that rosnilimab is effective in rheumatoid ...Participants who entered the extended treatment period showed sustained responses in multiple efficacy outcomes. Overall, rosnilimab was well ...
Anaptys Announces New Positive Phase 2b Trial Results ...New data reinforce rosnilimab's efficacy profile in rheumatoid arthritis (RA) with deepening of clinical responses, including CDAI remission ...
A Study to Evaluate the Efficacy and Safety of Rosnilimab ...There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...
A Study of Efficacy and Safety of Rosnilimab in Subjects With ...This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
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