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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Pruritus, Atopic Dermatitis

Intervention / Treatment
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* Drug: BLU-5937
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm, parallel assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BLU-5937, Chronic Pruritus, Atopic Dermatitis, P2X3 receptor antagonist