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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04693195
Other study ID # CL-PR-5937-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 9, 2020
Est. completion date October 12, 2021

Study information

Verified date October 2022
Source Bellus Health Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

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

Study Design


Intervention

Drug:
BLU-5937
Oral administration of BLU-5937 tablets
Placebo
Oral administration of matching placebo for BLU-5937 tablets

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bellus Health Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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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