A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis (ADmIRe)

Lilly

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: LY3375880

Study type: Interventional

Funder types: Industry

Identifiers

NCT03831191

2018-002401-56 (EudraCT Number)

I9N-MC-FCAB (Other Identifier)

17104

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD).

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have diagnosis of AD >= 12 months according to the American Academy of Dermatology criteria.
• Participants must have moderate to severe AD at screening and randomization.
• Participants must have inadequate response to topical medications within 6 months of screening (or history of intolerance).

Exclusion criteria

• Participants must not have concurrent treatment with topical or systemic treatments for AD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 4 patient groups, including a placebo group

50 mg LY3375880

Experimental group

Description:

Induction Period: Participants received 50 mg LY3375880 administered SC Q4W.

Treatment:

Drug: LY3375880

150 mg LY3375880

Experimental group

Description:

Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.

Treatment:

Drug: LY3375880

600 mg LY3375880

Experimental group

Description:

Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.

Treatment:

Drug: LY3375880

Placebo

Placebo Comparator group

Description:

Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Treatment:

Drug: Placebo