LY3541860 for Rheumatoid Arthritis

Recruiting at 21 trial locations

Overseen By Alan Kivitz

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must not be taking: Corticosteroids, Opioids, JAK inhibitors

Disqualifiers: Malignant disease, Chronic kidney disease, 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: 24 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate the effects of LY3541860 in adult participants with moderately to severely active Rheumatoid Arthritis with inadequate response to a least one biologic disease-modifying antirheumatic drug (bDMARD)or targeted synthetic disease-modifying antirheumatic drug (tsDMARD). Study participation is approximately 50 weeks, including a 6-week screening period, 24-week treatment period, and a 20-week safety follow up period.

Will I have to stop taking my current medications?

The trial requires that you do not change the dose of corticosteroids, opioids, or conventional disease-modifying antirheumatic drugs (cDMARDs) and that you do not take Janus kinase (JAK) inhibitors within 28 days before the screening MRI or during the study.

What data supports the effectiveness of the drug LY3541860 for treating rheumatoid arthritis?

While there is no direct data on LY3541860, similar treatments like tofacitinib and filgotinib, which are also Janus kinase inhibitors, have shown effectiveness in treating rheumatoid arthritis by reducing disease activity and improving patient outcomes. ^{1 2 3 4 5}

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 moderate to severe Rheumatoid Arthritis who haven't had enough improvement with at least one biologic or synthetic disease-modifying drug. Participants should be able to commit to a 50-week study period.

Inclusion Criteria

I have active joint inflammation in my hand or wrist.

I have been diagnosed with Rheumatoid Arthritis for at least 3 months.

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

Exclusion Criteria

My kidney function is reduced, with an eGFR below 45 mL/min.

I currently have or recently had an infection.

I have received treatment targeting B-cells, like rituximab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive LY3541860 intravenously for rheumatoid arthritis treatment

24 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Treatment Details

Interventions

• LY3541860

Trial Overview The trial is testing LY3541860's effects on those with active Rheumatoid Arthritis. It includes a 6-week screening, a 24-week treatment phase, and a 20-week safety follow-up.

Participant Groups

Group I: LY3541860 Experimental Treatment 1 Intervention

LY3541860 will be administered intravenously (IV).

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

Tofacitinib has shown a consistent safety profile over 60 months in patients with moderate to severe rheumatoid arthritis, with common adverse events including nasopharyngitis and upper respiratory infections, and serious adverse events occurring in 15.4% of patients.

The drug demonstrated persistent efficacy over 48 months, as indicated by significant improvements in ACR response rates and disease activity scores, whether used alone or with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-label, longterm extension studies. Wollenhaupt, J., Silverfield, J., Lee, EB., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-label, longterm extension studies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Neutrophil-lymphocyte and platelet-lymphocyte ratios for assessing disease activity in patients with rheumatoid arthritis receiving tofacitinib treatment]. [2023]

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

LY2439821, a humanized anti-interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomized, double-blind, placebo-controlled, proof-of-concept study. [2022]

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

Association of first, second, and third-line bDMARDs and tsDMARD with drug survival among seropositive rheumatoid arthritis patients: Cohort study in A real world setting. [2021]