40 Participants Needed

LY3541860 for Rheumatoid Arthritis

Recruiting at 22 trial locations
Tm
Tq
Pi
Alan Kivitz profile photo
Overseen ByAlan Kivitz
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 tests a new treatment, LY3541860, for individuals with Rheumatoid Arthritis (RA) who haven't responded to other RA medications. It aims to evaluate the effectiveness of LY3541860 in those with moderate to severe symptoms. Participants receive the treatment through an IV (intravenous) and undergo several weeks of monitoring. The trial suits adults diagnosed with RA for at least three months who frequently experience joint swelling and tenderness, particularly in the hands or wrists. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that LY3541860 is likely to be safe for humans?

Research shows that LY3541860 is being tested for safety in treating rheumatoid arthritis. In one study, patients experienced some common side effects, similar to those with other treatments like tofacitinib, another drug for this condition. These side effects are usually mild, but the overall safety of LY3541860 remains under investigation. As a Phase 2 trial, the treatment has already demonstrated some safety in earlier tests. However, ongoing studies will provide more information on its tolerability.12345

Why do researchers think this study treatment might be promising for Rheumatoid Arthritis?

Unlike the standard treatments for rheumatoid arthritis, which typically include oral medications like methotrexate or biologics administered subcutaneously, LY3541860 is administered intravenously. This delivery method might offer more direct and potentially faster relief from symptoms. Researchers are also excited because LY3541860 could introduce a new active ingredient that targets inflammation differently, providing an innovative approach to managing this condition.

What evidence suggests that LY3541860 might be an effective treatment for Rheumatoid Arthritis?

Research has shown that LY3541860, the investigational treatment in this trial, may help treat rheumatoid arthritis. In earlier studies, patients taking LY3541860 experienced noticeable improvements in symptoms, such as reduced joint pain and swelling. Additionally, scores measuring arthritis activity significantly decreased over 48 months. This suggests that LY3541860 could be effective for individuals with moderate to severe rheumatoid arthritis, particularly for those who haven't found success with other treatments.23467

Who Is on the Research Team?

C1

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 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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: LY3541860Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

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.
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]

Citations

LY3541860 for Rheumatoid ArthritisThe drug demonstrated persistent efficacy over 48 months, as indicated by significant improvements in ACR response rates and disease activity scores, whether ...
A Study of LY3541860 in Adult Participants With Moderately to ...The main purpose of this study is to evaluate the effects of LY3541860 in adult participants with moderately to severely active Rheumatoid Arthritis with ...
Eli Lilly's Promising New Study on Rheumatoid Arthritis ...... LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis. ... results show promise in treating rheumatoid arthritis ...
LY3541860 / Eli LillyA Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor ...
A nondepleting anti-CD19 antibody impairs B cell function ...These results indicate that LY3541860 does not induce primary human B cell apoptosis in vitro, unlike another anti-CD19 antibody obexelimab. In ...
A Study of LY3541860 in Adult Participants With ...The main purpose of this study is to evaluate the effects of LY3541860 in adult participants with moderately to severely active Rheumatoid Arthritis with ...
LY-3541860 - Drug Targets, Indications, PatentsA Phase 2a, Single-Arm Study to Investigate the Efficacy and Safety of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security