LY3844583 for Atopic Dermatitis/Eczema

No longer recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called LY3844583 to determine its safety and tolerance in individuals with eczema (atopic dermatitis) and healthy participants. The study aims to understand the drug's absorption rate into the bloodstream and its duration in the body. Participants will receive either single, multiple, or repeat doses of the treatment or a placebo for comparison. Those who have had eczema for at least a year and struggle with or cannot use topical treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

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.

Is there any evidence suggesting that LY3844583 is likely to be safe for humans?

Research shows that LY3844583 is being tested for safety and tolerability in both healthy individuals and those with atopic dermatitis, a type of eczema. As this study is in its early stages (Phase 1), the primary focus is on safety, with researchers closely monitoring participants for any side effects or reactions.

Although detailed results from this study are not yet available, the testing of LY3844583 at this stage indicates it is still under careful review. This often means the treatment is just beginning to be evaluated for safety. Participants in these studies receive close monitoring to ensure their well-being, and any unwanted effects are reported and assessed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY3844583 for treating atopic dermatitis, commonly known as eczema, because it introduces a new delivery method and dosing flexibility. Unlike standard treatments, which often involve topical creams or oral medications, LY3844583 is administered either subcutaneously or intravenously, providing potentially faster or more targeted relief. This investigational treatment is also being explored in different dosing regimens, including single, multiple, and repeat doses, which could offer more personalized and effective management of the condition. By potentially working through a novel mechanism or pathway, LY3844583 could offer an alternative to existing therapies and address unmet needs for patients with eczema.

What evidence suggests that LY3844583 might be an effective treatment for atopic dermatitis?

Research has shown that upadacitinib, a drug similar to LY3844583, effectively treats moderate-to-severe atopic dermatitis, a type of eczema. Many patients experienced a 75% reduction in eczema symptoms, significantly improving their skin's appearance and feel. This improvement is measured by the Eczema Area and Severity Index (EASI-75). Upadacitinib also quickly and significantly enhanced patients' quality of life. Given its similarity to upadacitinib, LY3844583 might offer the same benefits for people with atopic dermatitis. Although LY3844583 is still under investigation in this trial, these early results are promising. Participants in this trial will receive either LY3844583 or a placebo to evaluate its effectiveness and safety. ^{1 2 4 6 7}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05486208

A Study of LY3844583 in Healthy Participants and ... The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis. The ...

2. withpower.com withpower.com/trial/phase-1-dermatitis-atopic-7-2022-a1301

LY3844583 for Atopic Dermatitis/Eczema The research indicates that upadacitinib, a drug similar to LY3844583, has shown high effectiveness in treating moderate-to-severe atopic dermatitis, with ...

3. investor.lilly.com investor.lilly.com/static-files/a3f7198b-e8be-4994-ae59-77272b5c8702

NOVEMBER 2, 2023 Atopic Dermatitis (ADorable-1). 3. 300. Percentage of Participants Achieving Eczema Area and. Severity Index-75 (EASI-75) ≥75% Reduction from ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38696027/

16-Week Results from Phase 3 Clinical Trials (Measure Up ... Upadacitinib therapy resulted in rapid, sustained improvements in PROs measuring symptom burden and QoL in adults and adolescents with moderate-to-severe AD.

5. springermedizin.de springermedizin.de/current-and-emerging-immunobiologic-therapies-for-atopic-dermati/27209478

Current and emerging immunobiologic therapies for atopic ... Two double-blind, vehicle-controlled clinical studies were performed with a total of 1249 patients over 8 weeks to assess efficacy and safety in the Topical ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly3844583-in-healthy-participants-and-participants-with-atopic-dermatitis

A Study of LY3844583 in Healthy Participants and Participants ... The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic ...

7. trial.medpath.com trial.medpath.com/clinical-trial/b2066ab98e153ed1/nct06937411-dc-853-safety-tolerability-pharmacokinetics

A Phase I Study to Evaluate the Safety, Tolerability ... - MedPath The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy ...