Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    BLU-5937
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693195
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Bellus Health Inc

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).

Condition or disease Intervention/treatment Phase
Chronic Pruritus Atopic Dermatitis Drug: BLU-5937 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Experimental: BLU-5937 oral tablet
Eligible participants will receive BLU-5937 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




Primary Outcome Measures :
  1. Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score [ Time Frame: Week 4 ]

    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 :
  1. Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score [ Time Frame: Week 4 ]

    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.


  2. Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score [ Time Frame: Week 4 ]

    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.


  3. Change from baseline in Itching Quality of Life Survey (ItchyQOL) [ Time Frame: Week 4 ]

    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.


  4. Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: Week 4 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693195


Contacts
Layout table for location contacts
Contact: Roxanne Julien, M.Sc. 1-450-680-4500 ext 4561 CTgov-CL-PR-5937-01@bellushealth.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Bellus Health Inc
Layout table for additonal information
Responsible Party: Bellus Health Inc
ClinicalTrials.gov Identifier: NCT04693195    
Other Study ID Numbers: CL-PR-5937-01
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bellus Health Inc:
BLU-5937
Chronic Pruritus
Atopic Dermatitis
P2X3 receptor antagonist
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations