A Master Protocol of Multiple Interventions for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis.

Lilly

Status and phase

Terminated

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: LY3454738

Study type

Interventional

Funder types

Industry

Identifiers

NCT07020351

18562

J4E-MC-FR01 (Other Identifier)

J4E-MC-IMMB (Other Identifier)

Details and patient eligibility

About

This platform trial is designed to enable the investigation of many interventions for AD by means of the introduction of new interventional specific addenda (ISAs) over time. At the inception of this platform trial, at least 1 ISA will be available. Additional ISAs will be added to the platform trial over time.

Enrollment

317 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Present with a diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
- Eczema Area and Severity Index (EASI) score ≥12
- Validated Investigator Global Assessment AD (vIGA-AD) score ≥3
- ≥10% of BSA involvement (per EASI BSA)
Are candidates for systemic therapy, and have a history, documented by a physician and/or the investigator, of inadequate response to existing topical medications within 6 months preceding screening.

Exclusion criteria

Have a history of eczema herpeticum:
- any episode within 12 months prior to screening, or
- 2 or more episodes during lifetime
Are currently experiencing or have a history of concomitant skin conditions other than AD, for example, psoriasis or cutaneous lupus, that, in the opinion of the investigator, would interfere with evaluations of the effect of study intervention on AD.
Are currently experiencing or have a history of erythrodermic, refractory, or unstable skin disease which requires frequent hospitalizations or IV treatment and, in the opinion of the investigator, could interfere with study participation
Are currently experiencing a skin infection that requires treatment with, or is currently being treated with, topical or systemic antibiotics.

Note: Participants who fail screening due to this criterion should not be rescreened until at least 4 weeks after screen failure and at least 2 weeks after resolution of the infection.