A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
NCT ID: NCT04693195
Last Updated: 2022-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2020-12-09
2021-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BLU-5937 oral tablet
Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.
BLU-5937
Oral administration of BLU-5937 tablets
Placebo oral tablet
Eligible participants will receive matching Placebo BID orally for 4 weeks.
Placebo
Oral administration of matching placebo for BLU-5937 tablets
Interventions
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BLU-5937
Oral administration of BLU-5937 tablets
Placebo
Oral administration of matching placebo for BLU-5937 tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bellus Health Inc. - a GSK company
INDUSTRY
Responsible Party
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Locations
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Bellus Health Investigational Site #28
Phoenix, Arizona, United States
Bellus Health Investigational Site #10
Scottsdale, Arizona, United States
Bellus Health Investigational Site #23
Beverly Hills, California, United States
Bellus Health Investigational Site #33
Encinitas, California, United States
Bellus Health Investigational Site #27
Fountain Valley, California, United States
Bellus Health Investigational Site #35
San Diego, California, United States
Bellus Health Investigational Site #15
Hialeah, Florida, United States
Bellus Health Investigational Site #32
Margate, Florida, United States
Bellus Health Investigational Site #16
Miami, Florida, United States
Bellus Health Investigational Site #19
Miami, Florida, United States
Bellus Health Investigational Site #17
Sweetwater, Florida, United States
Bellus Health Investigational Site #24
Savannah, Georgia, United States
Bellus Health Investigational Site #13
Owensboro, Kentucky, United States
Bellus Health Investigational Site #38
Baton Rouge, Louisiana, United States
Bellus Health Investigational Site #45
Covington, Louisiana, United States
Bellus Health Investigational Site #18
New Orleans, Louisiana, United States
Bellus Health Investigational Site #36
Minneapolis, Minnesota, United States
Bellus Health Investigational Site #22
Portsmouth, New Hampshire, United States
Bellus Health Investigational Site #34
New York, New York, United States
Bellus Health Investigational Site #14
High Point, North Carolina, United States
Bellus Health Investigational Site #29
Norman, Oklahoma, United States
Bellus Health Investigational Site #37
Newtown Square, Pennsylvania, United States
Bellus Health Investigational Site #41
Rapid City, South Dakota, United States
Bellus Health Investigational Site #12
Austin, Texas, United States
Bellus Health Investigational Site #31
College Station, Texas, United States
Bellus Health Investigational Site #40
San Antonio, Texas, United States
Bellus Health Investigational Site #11
San Antonio, Texas, United States
Bellus Health Investigational Site #25
Seattle, Washington, United States
Bellus Health Investigational Site #44
Chicoutimi, Quebec, Canada
Bellus Health Investigational Site #20
Montreal, Quebec, Canada
Bellus Health Investigational Site #43
Québec, Quebec, Canada
Bellus Health Investigational Site #39
Québec, Quebec, Canada
Bellus Health Investigational Site #42
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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CL-PR-5937-01
Identifier Type: -
Identifier Source: org_study_id
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