Peresolimab for Rheumatoid Arthritis

(RESOLUTION-1 Trial)

No longer recruiting at 191 trial locations

Overseen By Tanya R Bogle

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Poorly controlled diabetes, hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests peresolimab, a new treatment, to determine its safety and effectiveness for people with moderate to severe rheumatoid arthritis (RA). Participants will receive varying doses of peresolimab or a placebo, administered by injection, to compare outcomes. Ideal candidates are adults diagnosed with RA for at least three months, experiencing frequent joint swelling and tenderness, and who have not responded well to previous RA treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective RA treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response to certain RA treatments, which might imply that some changes to your medication could be necessary. Please consult with the trial coordinators for specific guidance.

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

Research has shown that peresolimab has been tested in people with rheumatoid arthritis to assess its safety. In these studies, most patients tolerated peresolimab well. Some participants experienced side effects, usually mild, such as headaches or minor skin reactions at the injection site.

Another study tested peresolimab's safety again, yielding similar results. Most side effects were not serious, and the treatment was deemed safe enough for further testing. While some individuals might experience mild discomfort, there have been no reports of serious safety issues among those who have tried it so far.

Overall, the safety data for peresolimab in these studies suggests it is generally well-tolerated by most people. However, like any treatment, there can be risks, and discussing these with the trial team or a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for rheumatoid arthritis?

Peresolimab is unique because it targets the immune system in a novel way, offering a potential new approach for treating rheumatoid arthritis. Unlike traditional treatments like methotrexate or TNF inhibitors, which suppress the immune response broadly, peresolimab is designed to modulate specific pathways involved in inflammation. This targeted action could result in fewer side effects and potentially greater effectiveness for patients who haven't responded well to existing therapies. Researchers are excited about peresolimab because its distinct mechanism of action holds promise for improving outcomes for those with rheumatoid arthritis.

What evidence suggests that this trial's treatments could be effective for rheumatoid arthritis?

Research shows that peresolimab may help treat rheumatoid arthritis. In an earlier study, peresolimab significantly reduced disease severity in patients. It achieved its main goal by improving symptoms in those with difficult-to-treat rheumatoid arthritis. The treatment targets the PD-1 receptor in the immune system. Early trial results support its effectiveness, offering hope to those facing this challenging condition. Participants in this trial will receive one of three different doses of peresolimab or a placebo, administered by subcutaneous injection. ^{1 2 5 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with rheumatoid arthritis that's moderately-to-severely active. Participants must have had the condition for at least 3 months and not responded well to previous treatments. They should not have severe RA, poorly controlled diabetes or hypertension, serious heart issues, chronic kidney disease stage IIIb or worse, or other major inflammatory diseases.

Inclusion Criteria

I have active RA with 6 or more swollen and tender joints.

I have not responded well to at least one standard arthritis treatment.

I have been diagnosed with rheumatoid arthritis for at least 3 months.

Exclusion Criteria

My rheumatoid arthritis is severe, limiting my ability to move.

Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to poorly controlled diabetes or hypertension, chronic kidney disease stage IIIb, IV, or V, symptomatic heart failure according to New York Heart Association Class II, III, or IV, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization, severe chronic pulmonary disease requiring oxygen therapy

I have a chronic inflammatory or connective tissue disease other than rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peresolimab or placebo by subcutaneous injection

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peresolimab
• Placebo

Trial Overview The study tests Peresolimab's safety and effectiveness against a placebo in treating rheumatoid arthritis. It aims to see if Peresolimab can help those who haven't done well on standard treatments.

How Is the Trial Designed?

Group I: Placebo SC Q4W to Peresolimab 400 mg SC Q4W Experimental Treatment 2 Interventions

Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.

Group II: Placebo SC Q4W to Peresolimab 1000 mg SC Q4W Experimental Treatment 2 Interventions

Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.

Group III: Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W Experimental Treatment 1 Intervention

Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.

Group IV: Peresolimab 400 mg SC Q4W Experimental Treatment 1 Intervention

Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.

Group V: Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W Experimental Treatment 1 Intervention

Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.

Group VI: Peresolimab 1000 mg SC Q4W Experimental Treatment 1 Intervention

Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.

Group VII: Peresolimab 100 mg SC Q4W Experimental Treatment 1 Intervention

Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Anti-TNF-alpha agents like etanercept, infliximab, and adalimumab have been shown to significantly reduce disease activity in rheumatoid arthritis (RA), with long-term studies indicating sustained clinical responses for up to 5 years.

Etanercept not only matches the efficacy of methotrexate in early RA but also outperforms it in preventing radiographic progression, suggesting that it may help reduce long-term costs associated with disease outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs that block tumour necrosis factor: experience in patients with rheumatoid arthritis. Moreland, LW.[2018]

Current treatments for rheumatoid arthritis, including analgesics and immunomodulators, often have limited efficacy or cause significant side effects, leading to a need for safer alternatives.

The article reviews several new pharmaceutical agents under investigation, such as zileuton and tenidap for inflammation, and leflunomide and mycophenolic acid for immunosuppression, which may offer better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational agents for rheumatoid arthritis. Merkel, PA., Letourneau, EN., Polisson, RP.[2007]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209856

A Phase 2 Trial of Peresolimab for Adults with Rheumatoid ... Peresolimab showed efficacy in a phase 2a trial in patients with rheumatoid arthritis. These results provide evidence that stimulation of the PD-1 receptor has ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37195941/

A Phase 2 Trial of Peresolimab for Adults with Rheumatoid ... Peresolimab showed efficacy in a phase 2a trial in patients with rheumatoid arthritis. These results provide evidence that stimulation of the PD-1 receptor has ...

3. 2minutemedicine.com 2minutemedicine.com/peresolimab-reduces-disease-severity-in-adults-with-rheumatoid-arthritis/

Peresolimab reduces disease severity in adults with ... 1. In this randomized controlled trial, there was a significant reduction in the Disease Activity Score of rheumatoid arthritis patients ...

4. prnewswire.com prnewswire.com/news-releases/lillys-peresolimab-phase-2a-rheumatoid-arthritis-trial-published-in-the-new-england-journal-of-medicine-301827782.html

Lilly's peresolimab Phase 2a rheumatoid arthritis trial ... Peresolimab met the primary efficacy endpoint in patients with refractory rheumatoid arthritis (RA). Study evaluated a novel approach to treating patients with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05516758

NCT05516758 | A Study of Peresolimab (LY3462817) in ... The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis ...

6. trials.lilly.com trials.lilly.com/en-US/trial/356796

A Study of Peresolimab (LY3462817) in Participants With ... The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis ...

7. the-rheumatologist.org the-rheumatologist.org/article/peresolimab-promising-for-ra/

Peresolimab Promising for RA This randomized clinical trial (NCT04634253) evaluated the safety and efficacy of peresolimab for treating adults with moderate to severe active rheumatoid ...