LY3871801 for Rheumatoid Arthritis

Recruiting at 87 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Class IV RA, Diabetes, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called LY3871801 (also known as ocadusertib) for individuals with moderately-to-severely active rheumatoid arthritis (RA). Researchers aim to assess the safety and effectiveness of this treatment compared to a placebo. Participants will be divided into groups receiving different doses of LY3871801 or a placebo. Candidates may qualify if they have had RA for at least three months, experience frequent joint swelling and tenderness, and have tried other RA treatments without success. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that LY3871801, a treatment being tested for rheumatoid arthritis, has promising safety results from earlier studies. Most patients tolerated LY3871801 well in these studies. Some experienced mild side effects, but serious problems were rare. These findings suggest that LY3871801 could be a safe option for treating rheumatoid arthritis, although further research is needed to confirm this. ^{1 2 3 4 5}

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

Researchers are excited about LY3871801 for rheumatoid arthritis because it offers a potentially new way to tackle the condition. Unlike the standard treatments, which often include disease-modifying antirheumatic drugs (DMARDs) like methotrexate and biologics targeting specific immune system components, LY3871801 introduces a new oral formulation. This investigational drug could simplify treatment with its oral administration, providing an alternative to injections or infusions. Additionally, LY3871801 might work through a novel mechanism, giving hope for improved outcomes or reduced side effects.

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

Research has shown that LY3871801, which participants in this trial may receive, may effectively treat moderate-to-severe rheumatoid arthritis (RA). Early studies indicated that patients experienced less joint swelling and pain. This suggests the treatment might help manage RA symptoms, a condition where the immune system attacks the joints, causing pain and inflammation. These initial results are promising, but more research is needed to fully understand the benefits and safety of LY3871801. ^{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 8 AM - 8 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 active moderate-to-severe rheumatoid arthritis (RA) who have had RA for at least 3 months and haven't responded well to previous treatments. Participants should have a significant number of swollen and tender joints. Those with severe other diseases or heart, kidney, lung problems, or different inflammatory conditions are excluded.

Inclusion Criteria

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

I have active rheumatoid arthritis with at least 6 swollen and 6 tender joints.

I've had an inadequate response or intolerance to at least one standard rheumatic drug and one advanced therapy.

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 IIIa or 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 do not have chronic inflammatory diseases other than RA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 2a

Participants receive LY3871801 or placebo administered orally

12 weeks

Treatment Phase 2b

Participants receive different doses of LY3871801 or placebo administered orally

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3871801
• Placebo

Trial Overview The study tests the effectiveness and safety of LY3871801 compared to a placebo in treating RA. It's an adaptive Phase 2a/2b trial, meaning it can change based on results as the trial progresses to find the best dose and treatment response.

How Is the Trial Designed?

Group I: LY3871801 Phase 2a Experimental Treatment 1 Intervention

Participants will receive LY3871801 administered orally.

Group II: LY3871801 Dose 3 Phase 2b Experimental Treatment 1 Intervention

Participants will receive LY3871801 administered orally.

Group III: LY3871801 Dose 2 Phase 2b Experimental Treatment 1 Intervention

Participants will receive LY3871801 administered orally.

Group IV: LY3871801 Dose 1 Phase 2b Experimental Treatment 1 Intervention

Participants will receive LY3871801 administered orally.

Group V: Placebo Phase 2a Placebo Group 1 Intervention

Participants will receive placebo.

Group VI: Placebo Phase 2b Placebo Group 1 Intervention

Participants will receive placebo.

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

Rigel Pharmaceuticals

Industry Sponsor

Trials

37

Recruited

4,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05848258

An Adaptive Phase 2a/2b Study of LY3871801 in Adult ... The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT05848258

An Adaptive Phase 2a/2b Study of LY3871801 in Adult ... The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis ( ...

3. trials.lilly.com trials.lilly.com/en-US/trial/401857

An Adaptive Phase 2a/2b Study of LY3871801 in ... - Lilly Trials The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis ...

4. drugpatentwatch.com drugpatentwatch.com/p/drugs-in-development/drugname/LY3871801?srsltid=AfmBOoqLGZtH0Ar-rP9oJ52G6N8ChhNjTCekKg1hbtNRxfg2dmayYNTd

LY3871801 clinical trial progress and patents: Drug ... Phase 2: Preliminary data from ongoing phase 2 trials targeting moderate-to-severe rheumatoid arthritis shows promising efficacy signals, including reductions ...

5. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/an-adaptive-phase-2a2b-study-of-ly3871801-in-adult-participants-with-rheumatoid-arthritis/

An Adaptive Phase 2a/2b Study of LY3871801 in Adult ... In this study we are trying to understand the safety and efficacy of different doses of LY3871801 to treat moderately-to-severely active RA in patients, ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800056379

Ocadusertib - Eli Lilly and Company - AdisInsight - Springer ... Safety and pharmacokinetics data from a phase I trial in Rheumatoid arthritis presented at the ACR Convergence 2024 (ACR-2024). You need to ...

7. acrabstracts.org acrabstracts.org/abstract/early-development-of-ocadusertib-a-selective-receptor-interacting-serine-threonine-protein-kinase-1-inhibitor/

Early Development of Ocadusertib, a Selective Receptor- ... Ocadusertib (LY3871801; R552) is a potent and selective allosteric inhibitor of RIPK1 that blocks inflammatory cell death and is currently being studied in ...