Atopic Dermatitis Clinical Trial
— BLUEPRINTOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety, and Tolerability of BLU-5937 for the Treatment of Chronic Pruritus in Adult Subjects With Atopic Dermatitis
Verified date | October 2022 |
Source | Bellus Health Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 142 |
Est. completion date | October 12, 2021 |
Est. primary completion date | October 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Bellus Health Investigational Site #44 | Chicoutimi | Quebec |
Canada | Bellus Health Investigational Site #20 | Montreal | Quebec |
Canada | Bellus Health Investigational Site #39 | Quebec city | Quebec |
Canada | Bellus Health Investigational Site #43 | Quebec City | Quebec |
Canada | Bellus Health Investigational Site #42 | Sherbrooke | Quebec |
United States | Bellus Health Investigational Site #12 | Austin | Texas |
United States | Bellus Health Investigational Site #38 | Baton Rouge | Louisiana |
United States | Bellus Health Investigational Site #23 | Beverly Hills | California |
United States | Bellus Health Investigational Site #31 | College Station | Texas |
United States | Bellus Health Investigational Site #45 | Covington | Louisiana |
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 #15 | Hialeah | Florida |
United States | Bellus Health Investigational Site #14 | High Point | North Carolina |
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 #36 | Minneapolis | Minnesota |
United States | Bellus Health Investigational Site #18 | New Orleans | Louisiana |
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 #29 | Norman | Oklahoma |
United States | Bellus Health Investigational Site #13 | Owensboro | Kentucky |
United States | Bellus Health Investigational Site #28 | Phoenix | Arizona |
United States | Bellus Health Investigational Site #22 | Portsmouth | New Hampshire |
United States | Bellus Health Investigational Site #41 | Rapid City | South Dakota |
United States | Bellus Health Investigational Site #11 | San Antonio | Texas |
United States | Bellus Health Investigational Site #40 | San Antonio | Texas |
United States | Bellus Health Investigational Site #35 | San Diego | California |
United States | Bellus Health Investigational Site #24 | Savannah | Georgia |
United States | Bellus Health Investigational Site #10 | Scottsdale | Arizona |
United States | Bellus Health Investigational Site #25 | Seattle | Washington |
United States | Bellus Health Investigational Site #17 | Sweetwater | Florida |
Lead Sponsor | Collaborator |
---|---|
Bellus Health Inc |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score | 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. |
Week 4 | |
Secondary | Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score | 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. |
Week 4 | |
Secondary | Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score | 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. |
Week 4 | |
Secondary | Change from baseline in Itching Quality of Life Survey (ItchyQOL) | 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. |
Week 4 | |
Secondary | Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire | 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. |
Week 4 |
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