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

Primary Purpose

Chronic Pruritus, Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BLU-5937
Placebo
Sponsored by
Bellus Health Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pruritus focused on measuring BLU-5937, Chronic Pruritus, Atopic Dermatitis, P2X3 receptor antagonist

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bellus Health Investigational Site #28
  • Bellus Health Investigational Site #10
  • Bellus Health Investigational Site #23
  • Bellus Health Investigational Site #33
  • Bellus Health Investigational Site #27
  • Bellus Health Investigational Site #35
  • Bellus Health Investigational Site #15
  • Bellus Health Investigational Site #32
  • Bellus Health Investigational Site #16
  • Bellus Health Investigational Site #19
  • Bellus Health Investigational Site #17
  • Bellus Health Investigational Site #24
  • Bellus Health Investigational Site #13
  • Bellus Health Investigational Site #38
  • Bellus Health Investigational Site #45
  • Bellus Health Investigational Site #18
  • Bellus Health Investigational Site #36
  • Bellus Health Investigational Site #22
  • Bellus Health Investigational Site #34
  • Bellus Health Investigational Site #14
  • Bellus Health Investigational Site #29
  • Bellus Health Investigational Site #37
  • Bellus Health Investigational Site #41
  • Bellus Health Investigational Site #12
  • Bellus Health Investigational Site #31
  • Bellus Health Investigational Site #40
  • Bellus Health Investigational Site #11
  • Bellus Health Investigational Site #25
  • Bellus Health Investigational Site #44
  • Bellus Health Investigational Site #20
  • Bellus Health Investigational Site #43
  • Bellus Health Investigational Site #39
  • Bellus Health Investigational Site #42

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BLU-5937 oral tablet

Placebo oral tablet

Arm Description

Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.

Eligible participants will receive matching Placebo BID orally for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 30, 2020
Last Updated
October 13, 2022
Sponsor
Bellus Health Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04693195
Brief Title
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellus Health Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pruritus, Atopic Dermatitis
Keywords
BLU-5937, Chronic Pruritus, Atopic Dermatitis, P2X3 receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two-arm, parallel assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLU-5937 oral tablet
Arm Type
Experimental
Arm Description
Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.
Arm Title
Placebo oral tablet
Arm Type
Placebo Comparator
Arm Description
Eligible participants will receive matching Placebo BID orally for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
BLU-5937
Intervention Description
Oral administration of BLU-5937 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration of matching placebo for BLU-5937 tablets
Primary Outcome Measure Information:
Title
Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
Description
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.
Time Frame
Week 4
Title
Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score
Description
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.
Time Frame
Week 4
Title
Change from baseline in Itching Quality of Life Survey (ItchyQOL)
Description
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.
Time Frame
Week 4
Title
Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire
Description
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.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bellus Health Investigational Site #28
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Bellus Health Investigational Site #10
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Bellus Health Investigational Site #23
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Bellus Health Investigational Site #33
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Bellus Health Investigational Site #27
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Bellus Health Investigational Site #35
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Bellus Health Investigational Site #15
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Bellus Health Investigational Site #32
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Bellus Health Investigational Site #16
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Bellus Health Investigational Site #19
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Bellus Health Investigational Site #17
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Bellus Health Investigational Site #24
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Bellus Health Investigational Site #13
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Bellus Health Investigational Site #38
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Bellus Health Investigational Site #45
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Bellus Health Investigational Site #18
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Bellus Health Investigational Site #36
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Bellus Health Investigational Site #22
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Bellus Health Investigational Site #34
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Bellus Health Investigational Site #14
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Bellus Health Investigational Site #29
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Bellus Health Investigational Site #37
City
Newtown Square
State/Province
Pennsylvania
ZIP/Postal Code
19073
Country
United States
Facility Name
Bellus Health Investigational Site #41
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Bellus Health Investigational Site #12
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Bellus Health Investigational Site #31
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Bellus Health Investigational Site #40
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Bellus Health Investigational Site #11
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Bellus Health Investigational Site #25
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Bellus Health Investigational Site #44
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7Y8
Country
Canada
Facility Name
Bellus Health Investigational Site #20
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Bellus Health Investigational Site #43
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Bellus Health Investigational Site #39
City
Quebec city
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Bellus Health Investigational Site #42
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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