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

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

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis; Chronic Pruritus
• Intervention / Treatment: Drug: BLU-5937; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • Bellus Health Investigational Site #44
    • Montreal, Quebec, Canada, H2X 2V1
      • Bellus Health Investigational Site #20
    • Quebec City, Quebec, Canada, G1N 4V3
      • Bellus Health Investigational Site #43
    • Quebec city, Quebec, Canada, G1W 4R4
      • Bellus Health Investigational Site #39
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Bellus Health Investigational Site #42
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Bellus Health Investigational Site #28
    • Scottsdale, Arizona, United States, 85254
      • Bellus Health Investigational Site #10
  • California
    • Beverly Hills, California, United States, 90212
      • Bellus Health Investigational Site #23
    • Encinitas, California, United States, 92024
      • Bellus Health Investigational Site #33
    • Fountain Valley, California, United States, 92708
      • Bellus Health Investigational Site #27
    • San Diego, California, United States, 92123
      • Bellus Health Investigational Site #35
  • Florida
    • Hialeah, Florida, United States, 33012
      • Bellus Health Investigational Site #15
    • Margate, Florida, United States, 33063
      • Bellus Health Investigational Site #32
    • Miami, Florida, United States, 33125
      • Bellus Health Investigational Site #16
    • Miami, Florida, United States, 33136
      • Bellus Health Investigational Site #19
    • Sweetwater, Florida, United States, 33172
      • Bellus Health Investigational Site #17
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Bellus Health Investigational Site #24
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Bellus Health Investigational Site #13
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Bellus Health Investigational Site #38
    • Covington, Louisiana, United States, 70433
      • Bellus Health Investigational Site #45
    • New Orleans, Louisiana, United States, 70115
      • Bellus Health Investigational Site #18
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Bellus Health Investigational Site #36
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Bellus Health Investigational Site #22
  • New York
    • New York, New York, United States, 10075
      • Bellus Health Investigational Site #34
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Bellus Health Investigational Site #14
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Bellus Health Investigational Site #29
  • Pennsylvania
    • Newtown Square, Pennsylvania, United States, 19073
      • Bellus Health Investigational Site #37
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Bellus Health Investigational Site #41
  • Texas
    • Austin, Texas, United States, 78759
      • Bellus Health Investigational Site #12
    • College Station, Texas, United States, 77845
      • Bellus Health Investigational Site #31
    • San Antonio, Texas, United States, 78213
      • Bellus Health Investigational Site #40
    • San Antonio, Texas, United States, 78229
      • Bellus Health Investigational Site #11
  • Washington
    • Seattle, Washington, United States, 98101
      • Bellus Health Investigational Site #25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLU-5937 oral tablet; Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.	Drug: BLU-5937; Oral administration of BLU-5937 tablets
Placebo Comparator: Placebo oral tablet; Eligible participants will receive matching Placebo BID orally for 4 weeks.	Drug: Placebo; Oral administration of matching placebo for BLU-5937 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Bellus Health Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): October 4, 2021
• Study Completion (Actual): October 12, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; BLU-5937; P2X3 receptor antagonist; Chronic Pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic
• Other Study ID Numbers: CL-PR-5937-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No