LY3844583 for Atopic Dermatitis/Eczema

Recruiting at 3 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 1

Sponsor: Eli Lilly and Company

Must not be taking: Biologics, Steroids, Antibodies, others

Disqualifiers: Tuberculosis, Cancer, Viral infections, others

Compensation: Varies

Number of Visits: 37

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called LY3844583 to see if it is safe and well-tolerated. The study includes both healthy people and those with atopic dermatitis. Researchers will check how fast the drug gets into the blood and how long it stays there.

Will I have to stop taking my current medications?

The trial requires that participants with atopic dermatitis stop using certain topical medications 2 weeks before starting the study and certain oral medications or phototherapy 4 weeks before. If you are using antibody-based biologic agents or steroids, there are specific timeframes you must follow before joining the trial.

What data supports the effectiveness of the drug LY3844583 for treating atopic dermatitis?

The research indicates that upadacitinib, a drug similar to LY3844583, has shown high effectiveness in treating moderate-to-severe atopic dermatitis, with significant improvements in skin condition observed in clinical trials. ^{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 healthy adults and those with atopic dermatitis (eczema). Healthy participants can be of any gender but must not have the potential to bear children. People of Japanese descent must be first-generation with a specific body size, while Chinese participants need to be at least third-generation with certain body criteria. Participants with eczema should meet disease duration requirements and agree to use daily moisturizer.

Inclusion Criteria

Healthy participants must be male or female not of childbearing potential

If you want to join the study as a healthy Japanese participant, you need to have Japanese ancestry and meet specific body mass index requirements.

Atopic dermatitis participants must have a specific body mass index, diagnosis duration, and agree to daily moisturizer use

Exclusion Criteria

Participants must not have health problems, laboratory test results, or ECG readings that could make it unsafe to participate

Participants must not have certain viral infections or received specific treatments within defined timeframes

Participants must not be currently participating in or have completed a clinical trial within the last 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single doses of LY3844583 or placebo administered subcutaneously and/or intravenously

12 weeks

10 visits

Treatment Part B

Multiple doses of LY3844583 or placebo administered subcutaneously and/or intravenously

16 weeks

13 visits

Treatment Part C

Repeat doses of LY3844583 or placebo administered subcutaneously and/or intravenously

26 weeks

14 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3844583
• Placebo

Trial Overview The study tests LY3844583's safety and how it affects the body in both healthy individuals and those with atopic dermatitis compared to a placebo. The trial has three parts, each lasting between 88-186 days, involving up to 14 visits. It measures how quickly LY3844583 enters the blood and its elimination rate.

Participant Groups

Group I: LY3844583 (Part C) Experimental Treatment 1 Intervention

Repeat doses of LY3844583 administered SC and/or IV.

Group II: LY3844583 (Part B) Experimental Treatment 1 Intervention

Multiple doses of LY3844583 administered SC and/or IV.

Group III: LY3844583 (Part A) Experimental Treatment 1 Intervention

Single doses of LY3844583 administered subcutaneously (SC) and/or intravenously (IV).

Group IV: Placebo (Part A) Placebo Group 1 Intervention

Placebo administered SC and/or IV.

Group V: Placebo (Part B) Placebo Group 1 Intervention

Placebo administered SC and/or IV.

Group VI: Placebo (Part C) Placebo Group 1 Intervention

Placebo administered SC and/or 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

In a 52-week Phase 3 study involving 206 adolescents with moderate-to-severe atopic dermatitis, lebrikizumab demonstrated a favorable safety profile, with only 2.4% of patients experiencing serious adverse events and the same percentage discontinuing treatment due to adverse events.

Lebrikizumab significantly improved atopic dermatitis symptoms, with 62.6% of patients achieving a 2-point improvement in the Investigator's Global Assessment and 81.9% achieving at least a 75% improvement in the Eczema Area and Severity Index by Week 52.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. Paller, AS., Flohr, C., Eichenfield, LF., et al.[2023]

In a study of 901 patients with moderate-to-severe atopic dermatitis, upadacitinib combined with topical corticosteroids (TCS) showed sustained efficacy over 52 weeks, with 50.8% and 69.0% of patients achieving significant skin improvement (EASI-75) at the lower and higher doses, respectively.

The treatment was well tolerated, with no new safety risks identified over the year-long study, and serious adverse events were rare, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. Silverberg, JI., de Bruin-Weller, M., Bieber, T., et al.[2022]

In a network meta-analysis of 19 randomized controlled trials involving systemic therapies for moderate-to-severe atopic dermatitis, upadacitinib 30 mg once daily showed the highest efficacy, with 83.6% of patients achieving a significant improvement in eczema severity (EASI-50 response).

Abrocitinib and dupilumab also demonstrated strong efficacy, particularly in combination therapy, but all active treatments had a higher incidence of treatment-emergent adverse events compared to placebo, with no significant differences in safety among the active treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. Silverberg, JI., Thyssen, JP., Fahrbach, K., et al.[2021]

Recent advancements in understanding atopic dermatitis (AD) have led to new FDA-approved therapies like crisaborole and dupilumab, which target specific pathways for increased efficacy and potentially fewer side effects compared to traditional treatments.

JAK-STAT inhibitors, such as baricitinib and upadacitinib, show particularly promising results in clinical studies, indicating a shift towards more effective and targeted therapies for managing AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and Emerging Therapies for Pediatric Atopic Dermatitis. Nguyen, HL., Anderson, KR., Tollefson, MM.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. [2023]

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

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

New and Emerging Therapies for Pediatric Atopic Dermatitis. [2022]

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

Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). [2023]