A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis (BLUEPRINT)

Bellus Health

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Chronic Pruritus

Treatments

Drug: Placebo

Drug: BLU-5937

Study type

Interventional

Funder types

Industry

Identifiers

NCT04693195

CL-PR-5937-01

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).

Full description

The study will consist of a 37-day Screening period (including a 7-day Run-In period), a 4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last dose of study drug.

Enrollment

142 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing to participate and is capable of giving informed consent
Clinically confirmed diagnosis of active AD with at least a 6-month history of AD
Chronic pruritus related to AD for at least 3 months
Moderate to severe itch associated with mild to moderate AD
Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration

Exclusion criteria

History of skin disease or presence of skin condition that would interfere with the study assessments
Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis
Subject is >65 years of age and has developed pruritus at age of ≥50 years
History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
Known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to Screening
Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or human immunodeficiency virus [HIV])
Known history of clinically significant drug or alcohol abuse in the last year
Previous participation in a BLU-5937 trial