A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Lilly

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: LY3454738

Study type: Interventional

Funder types: Industry

Identifiers

NCT05911841

18569

FR01 ISA (Other Identifier)

J4E-MC-FR01 (Other Identifier)

2022-502888-38-00 (Other Identifier)

J4E-MC-IMMB Master Protocol (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).

Enrollment: 234 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are candidates for systemic therapy.

ISA specific:

• Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:

  • EASI score greater than or equal to (≥)16
  • vIGA-AD score ≥3, and
  • ≥10% of BSA involvement (per EASI BSA).

• Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.

Exclusion criteria

ISA specific:

• Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
• Are currently being treated with topical or systemic therapy
• Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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234 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo administered subcutaneously (SC) every two weeks (Q2W) from baseline to Week 14. Week 16 responders entered maintenance period and received placebo SC every four weeks (Q4W) until Week 40. Week 16 non-responders entered escape arm and received 800 milligrams (mg) of LY3454738 administered SC Q4W until Week 40.

Treatment:

Drug: LY3454738

Drug: Placebo

75 mg LY3454738

Experimental group

Description:

Participants received 75 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and received 150 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.

Treatment:

Drug: LY3454738

300 mg LY3454738

Experimental group

Description:

Participants received 300 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and continued receiving 300 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.

Treatment:

Drug: LY3454738

800 mg LY3454738

Experimental group

Description:

Participants received 800 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and were re-randomized to either receive 800 mg of LY3454738 or placebo administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.

Treatment:

Drug: LY3454738