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

Phase 2

Completed

Conditions: Chronic Pruritus
Atopic Dermatitis

Interventions: Drug: Placebo
Drug: BLU-5937

Registration Number: NCT04693195

Lead Sponsor: Bellus Health Inc. - a GSK company

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 142

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oral tablet	Placebo	Eligible participants will receive matching Placebo BID orally for 4 weeks.
BLU-5937 oral tablet	BLU-5937	Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score	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

Name	Time	Method
Change from baseline in Itching Quality of Life Survey (ItchyQOL)	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.
Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score	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.
Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score	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.
Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire	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.

Trial Locations

Locations (33): Bellus Health Investigational Site #28
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Phoenix, Arizona, United States
Bellus Health Investigational Site #10
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Scottsdale, Arizona, United States
Bellus Health Investigational Site #23
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Beverly Hills, California, United States
Bellus Health Investigational Site #33
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Encinitas, California, United States
Bellus Health Investigational Site #27
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Fountain Valley, California, United States
Bellus Health Investigational Site #35
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San Diego, California, United States
Bellus Health Investigational Site #15
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Hialeah, Florida, United States
Bellus Health Investigational Site #32
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Margate, Florida, United States
Bellus Health Investigational Site #16
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Miami, Florida, United States
Bellus Health Investigational Site #19
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Miami, Florida, United States
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Bellus Health Investigational Site #28
🇺🇸Phoenix, Arizona, United States