LY3361237 for Lupus

Recruiting at 75 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

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called LY3361237 to see if it helps people with moderately active systemic lupus erythematosus (SLE). The study will last several months and include multiple visits. The goal is to find out if LY3361237 can reduce the symptoms and activity of SLE.

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.

What data supports the effectiveness of the drug LY3361237 for treating lupus?

The research mentions belimumab, a drug recently approved for treating lupus, which has shown effectiveness in achieving low disease activity and remission in lupus patients. This suggests that drugs targeting similar pathways, like LY3361237, might also be effective. ^{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 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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Systemic lupus erythematosus: an update on current pharmacotherapy and future directions. [2019]

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

Real-world efficacy of belimumab in achieving remission or low-disease activity in systemic lupus erythematosus: A retrospective study. [2023]

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

Patient- and Physician-reported Satisfaction With Systemic Lupus Erythematosus Treatment in US Clinical Practice. [2018]

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

Remission and Low Disease Activity Status (LDAS) protect lupus patients from damage occurrence: data from a multiethnic, multinational Latin American Lupus Cohort (GLADEL). [2021]

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

Time to Lupus Low Disease Activity State in the Hopkins Lupus Cohort: Role of African American Ethnicity. [2022]