A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
- Registration Number
- NCT04693195
- Lead Sponsor
- Bellus Health Inc. - a GSK company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo oral tablet Placebo Eligible participants will receive matching Placebo BID orally for 4 weeks. BLU-5937 oral tablet BLU-5937 Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score Week 4 Assessed by Worst Itch Numeric Rating Scale \[WI-NRS\]
The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
- Secondary Outcome Measures
Name Time Method Change from baseline in Itching Quality of Life Survey (ItchyQOL) Week 4 Assessed by Itching Quality of Life Survey \[ItchyQOL\]
The ItchyQOL is a 22-item questionnaire assessing the pruritus-specific disease burden on 3 domains: symptoms, functions and emotions. The responses to the frequency items are scored on a 1 (never) to 5 (all the time) scale. The recall period in ItchyQoL is the past week. Higher scores indicate a more adverse impact on quality of life.Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score Week 4 Assessed by Worst Itch Numeric Rating Scale \[WI-NRS\]
The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score Week 4 Assessed by Average Itch Numeric Rating Scale \[AI-NRS\]
The AI-NRS is a single item questionnaire assessing the patient-reported severity of itch overall (on average) during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire Week 4 Assessed by Patient Global Impression of Change \[PGIC\]
The PGIC consists of 1 self-administered item that assesses the subject's impression of change in the severity of pruritus using a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher scores indicate a worsening of the severity.
Trial Locations
- Locations (33)
Bellus Health Investigational Site #29
🇺🇸Norman, Oklahoma, United States
Bellus Health Investigational Site #25
🇺🇸Seattle, Washington, United States
Bellus Health Investigational Site #15
🇺🇸Hialeah, Florida, United States
Bellus Health Investigational Site #10
🇺🇸Scottsdale, Arizona, United States
Bellus Health Investigational Site #45
🇺🇸Covington, Louisiana, United States
Bellus Health Investigational Site #17
🇺🇸Sweetwater, Florida, United States
Bellus Health Investigational Site #20
🇨🇦Montreal, Quebec, Canada
Bellus Health Investigational Site #38
🇺🇸Baton Rouge, Louisiana, United States
Bellus Health Investigational Site #42
🇨🇦Sherbrooke, Quebec, Canada
Bellus Health Investigational Site #19
🇺🇸Miami, Florida, United States
Bellus Health Investigational Site #41
🇺🇸Rapid City, South Dakota, United States
Bellus Health Investigational Site #16
🇺🇸Miami, Florida, United States
Bellus Health Investigational Site #22
🇺🇸Portsmouth, New Hampshire, United States
Bellus Health Investigational Site #43
🇨🇦Quebec City, Quebec, Canada
Bellus Health Investigational Site #39
🇨🇦Quebec city, Quebec, Canada
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 #32
🇺🇸Margate, Florida, United States
Bellus Health Investigational Site #13
🇺🇸Owensboro, Kentucky, United States
Bellus Health Investigational Site #24
🇺🇸Savannah, Georgia, United States
Bellus Health Investigational Site #34
🇺🇸New York, New York, United States
Bellus Health Investigational Site #37
🇺🇸Newtown Square, Pennsylvania, United States
Bellus Health Investigational Site #14
🇺🇸High Point, North Carolina, United States
Bellus Health Investigational Site #31
🇺🇸College Station, Texas, United States
Bellus Health Investigational Site #44
🇨🇦Chicoutimi, Quebec, Canada
Bellus Health Investigational Site #28
🇺🇸Phoenix, Arizona, United States
Bellus Health Investigational Site #35
🇺🇸San Diego, California, 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 #12
🇺🇸Austin, Texas, United States
Bellus Health Investigational Site #40
🇺🇸San Antonio, Texas, United States
Bellus Health Investigational Site #11
🇺🇸San Antonio, Texas, United States