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

CompletedPhase 2

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Chronic Pruritus, Atopic Dermatitis

Interventions: BLU-5937, Placebo

Countries: United States, Canada

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (33)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Beverly Hills, California, United States
Encinitas, California, United States
Fountain Valley, California, United States
San Diego, California, United States
Hialeah, Florida, United States
Margate, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Sweetwater, Florida, United States
Savannah, Georgia, United States
Owensboro, Kentucky, United States
Baton Rouge, Louisiana, United States
Covington, Louisiana, United States
New Orleans, Louisiana, United States
Minneapolis, Minnesota, United States
Portsmouth, New Hampshire, United States
New York, New York, United States
High Point, North Carolina, United States
Norman, Oklahoma, United States
Newtown Square, Pennsylvania, United States
Rapid City, South Dakota, United States
Austin, Texas, United States
College Station, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
+ 3 more on CT.gov