A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— BLUEPRINT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693195
• Other study ID #: CL-PR-5937-01
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Chronic Pruritus
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

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