Peresolimab for Rheumatoid Arthritis

(RESOLUTION-1 Trial)

Recruiting at 172 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

491 Participants Needed

Trial Summary

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.

How does the drug Peresolimab differ from other treatments for rheumatoid arthritis?

The research does not provide specific information about Peresolimab, so its unique features compared to existing treatments for rheumatoid arthritis are not detailed. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medication called peresolimab to see if it is safe and effective for adults with moderate to severe rheumatoid arthritis. The medication aims to reduce inflammation and joint damage by calming the immune system.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Peresolimab Dose 3 Experimental Treatment 1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group II: Peresolimab Dose 2 Experimental Treatment 1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group III: Peresolimab Dose 1 Experimental Treatment 1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group IV: Placebo Active Control 1 Intervention

Participants will be give placebo by subcutaneous injection.

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

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. Canada pubmed.ncbi.nlm.nih.gov

A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Investigational agents for rheumatoid arthritis. [2007]