Status:
COMPLETED
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
Lead Sponsor:
Bellus Health Inc. - a GSK company
Conditions:
Chronic Pruritus
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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).
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04693195
Start Date
December 9 2020
End Date
October 12 2021
Last Update
October 17 2022
Active Locations (33)
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1
Bellus Health Investigational Site #28
Phoenix, Arizona, United States, 85032
2
Bellus Health Investigational Site #10
Scottsdale, Arizona, United States, 85254
3
Bellus Health Investigational Site #23
Beverly Hills, California, United States, 90212
4
Bellus Health Investigational Site #33
Encinitas, California, United States, 92024