A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Pruritus, Atopic Dermatitis
In brief
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).
Key facts
- Study ID
- NCT04693195
- Run by
- Bellus Health Inc. - a GSK company
- People needed
- 142
- Starts
- 2020-12-09
- Expected to finish
- 2021-10-12
- Last updated by the study team
- 2022-10-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.