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Completed

NCT Number: NCT04693195

A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated 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).

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Key information

Conditions

Chronic Pruritus Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bellus Health Investigational Site #44, Chicoutimi, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLU-5937

Drug

Oral administration of BLU-5937 tablets

Placebo

Drug

Oral administration of matching placebo for BLU-5937 tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bellus Health Inc. - a GSK company

Industry

Registry information

Official study 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

Acronym: BLUEPRINT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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