LY3454738 for Atopic Dermatitis

Recruiting at 92 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 not be taking: Topical therapy, Systemic therapy

Disqualifiers: Skin conditions, Infections, Medical conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

236 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called LY3454738 to see if it helps adults with serious cases of atopic dermatitis. The goal is to find out if it can safely reduce symptoms like itching and inflammation.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking any current topical or systemic therapy to participate in the trial.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current topical or systemic therapy before joining this trial.

What data supports the idea that the drug LY3454738 for Atopic Dermatitis is an effective treatment?

The available research does not provide specific data on LY3454738 for Atopic Dermatitis. Instead, it focuses on another drug, Dupilumab, which has shown effectiveness in treating moderate-to-severe Atopic Dermatitis. Dupilumab has been proven to improve clinical signs, symptoms, and quality of life for patients with this condition. Without specific data on LY3454738, we cannot compare its effectiveness to Dupilumab or confirm its success in treating Atopic Dermatitis. ^{1 2 3 4 5}

What safety data exists for LY3454738 (Ucenprubart) in treating atopic dermatitis?

The provided research does not contain any safety data for LY3454738 (Ucenprubart) or its other names. The studies focus on the safety and efficacy of Dupilumab, a different treatment for atopic dermatitis. ^{1 2 4 6 7}

Is the drug LY3454738 a promising treatment for Atopic Dermatitis?

The information provided does not mention LY3454738 or its effectiveness for Atopic Dermatitis. Therefore, we cannot determine if LY3454738 is a promising treatment based on the given data. ^{1 2 6 8 9}

How is the drug LY3454738 different from other treatments for atopic dermatitis?

LY3454738, also known as Ucenprubart, is unique because it targets the CD200R pathway, which is different from other treatments like dupilumab that target the IL-4/IL-13 pathway. This novel mechanism may offer an alternative for patients who do not respond to existing therapies. ^{1 2 6 8 9}

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 adults with moderate-to-severe atopic dermatitis (AD), who need systemic therapy. Participants should have an EASI score of 16 or more, a vIGA-AD score of at least 3, and AD affecting 10% or more of their body. They must use emollients daily for two weeks before and throughout the study. Those with certain skin conditions, infections, medical issues, or recent treatments are excluded.

Inclusion Criteria

I am a candidate for treatment that affects my whole body.

I have severe eczema with a high EASI score, vIGA-AD score, and it covers more than 10% of my body.

I have used a moisturizer daily for at least 2 weeks and will continue to do so during the study.

Exclusion Criteria

I am currently on medication applied to my skin or taken by mouth/injection.

I do not have any listed skin conditions, infections, or serious health issues.

I have recently been treated with experimental drugs, but it's required for some participants.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3454738 or placebo subcutaneously for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3454738

Trial Overview The trial is testing LY3454738's effectiveness and safety in treating AD compared to a placebo. Participants will be randomly assigned to receive either the investigational drug LY3454738 or a placebo without knowing which one they're getting.

Participant Groups

Group I: LY3454738 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY3454738 SC.

Group II: LY3454738 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY3454738 SC.

Group III: LY3454738 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY3454738 subcutaneously (SC).

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

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 study of 109 adults with moderate-to-severe atopic dermatitis treated with dupilumab, significant improvements were observed in disease severity and quality of life after 4 and 16 weeks, with 87.2% of patients achieving a 50% reduction in severity by week 16.

The treatment was generally safe, with only 19.2% of patients experiencing mild adverse events, the most common being conjunctivitis, indicating a favorable safety profile for dupilumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis. Fargnoli, MC., Esposito, M., Ferrucci, S., et al.[2022]

Dupilumab is an effective treatment for moderate-to-severe atopic dermatitis (AD), showing significant improvements in clinical signs, patient-reported symptoms, and quality of life, leading to its approval in 2017.

The drug works by targeting the IL-4 receptor alpha subunit, which is involved in the Th-2-mediated immune response that drives the inflammation in AD, making it a targeted therapy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab use in atopic dermatitis and beyond in skin diseases. Fourzali, K., Golpanian, RS., Yosipovitch, G.[2021]

Dupilumab significantly improved the SCORing Atopic Dermatitis (SCORAD) scores in adults with moderate-to-severe atopic dermatitis as early as Week 1 or 2, demonstrating its rapid efficacy compared to placebo.

In a post hoc analysis of 2,444 patients from four phase 3 trials, dupilumab showed sustained improvements in SCORAD outcomes, regardless of whether it was used alone or with topical corticosteroids, indicating its effectiveness in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab provides rapid and sustained improvement in SCORAD outcomes in adults with moderate-to-severe atopic dermatitis: combined results of four randomized phase 3 trials. Barbarot, S., Wollenberg, A., Silverberg, JI., et al.[2022]

Dupilumab, a monoclonal antibody targeting the IL-4 receptor, significantly improved the molecular signature of severe atopic dermatitis (AD) in a dose-dependent manner, with a 65% reduction in upregulated genes at the 300 mg dose.

The treatment led to rapid changes in gene expression related to inflammation and skin hyperplasia, indicating that IL-4 and IL-13 play a crucial role in the inflammatory processes of AD, while showing no significant effect on TH1-associated genes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. Hamilton, JD., Suárez-Fariñas, M., Dhingra, N., et al.[2022]

In a phase IIa trial involving 64 adults with moderate-to-severe atopic dermatitis, dupilumab significantly improved health-related quality of life (HRQoL) as measured by the Quality of Life Index of Atopic Dermatitis (QoLIAD) after 12 weeks compared to placebo, with a mean percentage change of -64.0% versus -11.1%.

Improvements in QoLIAD scores were strongly correlated with clinical efficacy outcomes, such as the Eczema Area and Severity Index (EASI) and various pruritus scales, indicating that dupilumab not only enhances quality of life but also effectively reduces the severity of atopic dermatitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Tsianakas, A., Luger, TA., Radin, A.[2019]

In a study of 69 patients with moderate to severe atopic dermatitis (AD) who were not responding adequately to dupilumab alone, 12 patients received additional treatments, such as methylprednisolone or phototherapy, and 11 of them showed significant improvement after 8 weeks.

The combination therapy was well-tolerated, with no adverse events reported, suggesting that adding conventional drugs or phototherapy to dupilumab can be a safe and effective option for patients struggling with treatment-resistant AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Combination of Systemic Agents for the Treatment of Atopic Dermatitis Resistant to Dupilumab Therapy. Gori, N., Chiricozzi, A., Malvaso, D., et al.[2021]

Dupilumab significantly improved clinical outcomes in Asian children and adolescents with moderate-to-severe atopic dermatitis, as evidenced by reductions in the Investigator Global Assessment (IGA) score from 4 to 2.2 and the Eczema Area and Severity Index (EASI) score from 48.2 to 19.3 after 12 to 16 weeks of treatment.

The treatment also enhanced quality of life for both patients and caregivers, with notable reductions in the Teenager's Quality of Life (T-QoL) and Dermatitis Family Impact (DFI) scores, while demonstrating a favorable safety profile with only mild adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for children and adolescents with atopic dermatitis: An Asian perspective. Chia, SY., Wee, LWY., Koh, MJA.[2021]

Dupilumab, administered either weekly or every two weeks, significantly improved symptoms of moderate-to-severe atopic dermatitis (AD) in adults after 12 weeks, including reductions in itch and sleep loss, with p-values less than 0.0001 compared to placebo.

The treatment demonstrated an acceptable safety profile, making dupilumab a promising new option for managing moderate-to-severe AD in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults: A pooled analysis of two phase 2 clinical trials. Tofte, SJ., Papp, K., Sadick, N., et al.[2021]

In a 16-week phase III trial involving 325 adults with atopic dermatitis who did not respond well to ciclosporin A, dupilumab combined with topical corticosteroids significantly improved skin condition, with over 59% of patients achieving a 75% improvement in eczema severity compared to only 29% in the placebo group.

The safety profile of dupilumab was comparable to placebo, with similar rates of adverse events, although conjunctivitis was more common in the dupilumab group, indicating it is a safe and effective alternative for patients intolerant to ciclosporin A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ). de Bruin-Weller, M., Thaçi, D., Smith, CH., et al.[2019]

References

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

Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis. [2022]

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

Dupilumab use in atopic dermatitis and beyond in skin diseases. [2021]

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

Dupilumab provides rapid and sustained improvement in SCORAD outcomes in adults with moderate-to-severe atopic dermatitis: combined results of four randomized phase 3 trials. [2022]

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

Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Combination of Systemic Agents for the Treatment of Atopic Dermatitis Resistant to Dupilumab Therapy. [2021]

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

Dupilumab for children and adolescents with atopic dermatitis: An Asian perspective. [2021]

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

Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults: A pooled analysis of two phase 2 clinical trials. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ). [2019]