LY3361237 for Lupus

No longer recruiting at 82 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Standard-of-care medications

Must not be taking: Parenteral corticosteroids

Disqualifiers: Active infection, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 15

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, LY3361237, for individuals with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body, causing inflammation and pain. The trial aims to evaluate the effectiveness and safety of LY3361237. Participants will receive either the new treatment or a placebo (a harmless, inactive substance) alongside their usual care. The trial seeks individuals who have managed SLE for at least six months and are currently undergoing some form of treatment for the condition. As a Phase 2 trial, the research focuses on assessing 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 continue taking at least one standard medication for lupus. However, if you are on high doses of oral corticosteroids or have recently changed your dose, you may need to adjust your medication before joining the study.

Is there any evidence suggesting that LY3361237 is likely to be safe for humans?

Research shows that LY3361237 has been tested in people with systemic lupus erythematosus (SLE). Early results indicate that most people tolerate it well. Some participants experienced side effects, but these were usually mild and manageable. No serious safety issues have emerged so far. The treatment's progression to Phase 2 indicates sufficient evidence to move beyond initial safety tests. However, ongoing studies will provide more detailed information about its safety. ^{1 2 3 4 5}

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

Unlike the standard treatments for lupus, which often include immunosuppressive drugs and corticosteroids, LY3361237 offers a novel approach by being administered subcutaneously, which may improve patient convenience and adherence. Researchers are excited because LY3361237 targets specific pathways in the immune system, potentially offering a more precise treatment with fewer side effects. This could provide a significant advancement in managing lupus, offering hope for improved outcomes and quality of life for patients.

What evidence suggests that LY3361237 might be an effective treatment for lupus?

Research has shown that LY3361237, which participants in this trial may receive, might help manage symptoms of systemic lupus erythematosus (SLE). Early findings suggest this treatment targets specific parts of the immune system, potentially reducing inflammation and organ damage. Some patients demonstrated promising improvements in SLE symptoms compared to those who received a placebo. The treatment aims to provide better relief from the chronic symptoms of lupus by directly affecting immune activity. While more research is needed to confirm its full effectiveness, early results offer encouragement for those seeking new SLE management options. ^{1 3 4 5 6}

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 individuals with moderately active systemic lupus erythematosus (SLE) who have been diagnosed at least 24 weeks prior and are on standard SLE medication. Participants must have certain scores indicating active disease but cannot be on high doses of corticosteroids or have had recent severe infections, HIV, hepatitis, TB, or significant cardiac events.

Inclusion Criteria

Are diagnosed with SLE at least 24 weeks before Day 1 of study

Have documentation of having a score of 10 or more points on the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE

Have a SLEDAI-2K score ≥6 at screening (Day 1) and clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥4 (not including any items related to laboratory values) at randomization (Day 2)

Exclusion Criteria

Participants are excluded if they have received any of the following medications or therapies within the indicated timeframe prior to the randomization visit (Day 2).

Are currently receiving oral corticosteroids at doses >20 mg per day of prednisone (or equivalent) or have adjusted the dosage of corticosteroids within 2 weeks before starting study treatment

Have received parenteral corticosteroids within 12 weeks before starting study treatment or are expected to require parenteral corticosteroids during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3361237 or placebo subcutaneously along with standard of care

24 weeks

Up to 15 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3361237

Trial Overview The study tests the efficacy and safety of LY3361237 in managing SLE symptoms compared to a placebo. Over up to 34 weeks and possibly 15 visits, participants will receive either the investigational drug or a placebo while continuing their usual SLE treatments.

How Is the Trial Designed?

Group I: LY3361237 Experimental Treatment 1 Intervention

Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)

Group II: Placebo Placebo Group 1 Intervention

Placebo administered SC and SOC given at matching intervals

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

In a study of systemic lupus erythematosus (SLE) patients, the probability of reaching a lupus low disease activity state (LLDAS) within one year was 52% for Caucasians, but only 36% for African Americans and 33% for those with renal involvement, highlighting disparities in treatment outcomes.

Factors such as African American ethnicity, high baseline prednisone use, and renal activity were significant predictors of a longer time to achieve LLDAS, indicating the need for tailored approaches in managing SLE, especially for African American patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to Lupus Low Disease Activity State in the Hopkins Lupus Cohort: Role of African American Ethnicity. Babaoğlu, H., Li, J., Goldman, D., et al.[2022]

Belimumab has been approved for treating adult patients with mild-to-moderate seropositive lupus, marking a significant advancement in lupus therapy despite previous negative trial outcomes.

The review emphasizes that successful clinical trials for lupus depend not only on the drug's efficacy and dosing but also on careful selection of patient criteria and evidence-based outcomes, suggesting areas for improvement in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic lupus erythematosus: an update on current pharmacotherapy and future directions. Touma, Z., Urowitz, MB., Gladman, DD.[2019]

Citations

1. ctv.veeva.com ctv.veeva.com/study/a-imma-master-protocol-a-study-of-ly3361237-in-participants-with-at-least-moderately-active-systemi

A IMMA Master Protocol: A Study of LY3361237 in Participants ... The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05123586

Study Details | NCT05123586 | A IMMA Master Protocol: A ... The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03933943

A Study of LY3361237 in Participants With Systemic Lupus ... The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants ...

4. withpower.com withpower.com/trial/phase-3-lupus-erythematosus-systemic-11-2021-21a6d

LY3361237 for Lupus · Info for Participants Trial Overview The study tests the efficacy and safety of LY3361237 in managing SLE symptoms compared to a placebo. Over up to 34 weeks and possibly 15 visits, ...

5. trials.lilly.com trials.lilly.com/en-US/trial/228011

A Study of LY3361237 in Participants With Systemic Lupus ... The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT05123586

A IMMA Master Protocol: A Study of LY3361237 in Participants ... The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus ( ...