A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

Daiichi Sankyo

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: SUN13834

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

ASBI 404

Details and patient eligibility

About

The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.

Enrollment

270 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female participants between 18 and 65 years of age.
A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria
At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.

Exclusion criteria

Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
Use of phototherapy or tanning beds within 6 weeks of screening
History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).