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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLU-5937 oral tablet | Experimental | Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks. |
|
| Placebo oral tablet | Placebo Comparator | Eligible participants will receive matching Placebo BID orally for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-5937 | Drug | Oral administration of BLU-5937 tablets |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellus Health Investigational Site #28 | Phoenix | Arizona | 85032 | United States | ||
| Bellus Health Investigational Site #10 |
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Two-arm, parallel assignment
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| Placebo |
| Drug |
Oral administration of matching placebo for BLU-5937 tablets |
|
| 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 |
| Scottsdale |
| Arizona |
| 85254 |
| United States |
| Bellus Health Investigational Site #23 | Beverly Hills | California | 90212 | United States |
| Bellus Health Investigational Site #33 | Encinitas | California | 92024 | United States |
| Bellus Health Investigational Site #27 | Fountain Valley | California | 92708 | United States |
| Bellus Health Investigational Site #35 | San Diego | California | 92123 | United States |
| Bellus Health Investigational Site #15 | Hialeah | Florida | 33012 | United States |
| Bellus Health Investigational Site #32 | Margate | Florida | 33063 | United States |
| Bellus Health Investigational Site #16 | Miami | Florida | 33125 | United States |
| Bellus Health Investigational Site #19 | Miami | Florida | 33136 | United States |
| Bellus Health Investigational Site #17 | Sweetwater | Florida | 33172 | United States |
| Bellus Health Investigational Site #24 | Savannah | Georgia | 31406 | United States |
| Bellus Health Investigational Site #13 | Owensboro | Kentucky | 42301 | United States |
| Bellus Health Investigational Site #38 | Baton Rouge | Louisiana | 70809 | United States |
| Bellus Health Investigational Site #45 | Covington | Louisiana | 70433 | United States |
| Bellus Health Investigational Site #18 | New Orleans | Louisiana | 70115 | United States |
| Bellus Health Investigational Site #36 | Minneapolis | Minnesota | 55402 | United States |
| Bellus Health Investigational Site #22 | Portsmouth | New Hampshire | 03801 | United States |
| Bellus Health Investigational Site #34 | New York | New York | 10075 | United States |
| Bellus Health Investigational Site #14 | High Point | North Carolina | 27262 | United States |
| Bellus Health Investigational Site #29 | Norman | Oklahoma | 73071 | United States |
| Bellus Health Investigational Site #37 | Newtown Square | Pennsylvania | 19073 | United States |
| Bellus Health Investigational Site #41 | Rapid City | South Dakota | 57702 | United States |
| Bellus Health Investigational Site #12 | Austin | Texas | 78759 | United States |
| Bellus Health Investigational Site #31 | College Station | Texas | 77845 | United States |
| Bellus Health Investigational Site #40 | San Antonio | Texas | 78213 | United States |
| Bellus Health Investigational Site #11 | San Antonio | Texas | 78229 | United States |
| Bellus Health Investigational Site #25 | Seattle | Washington | 98101 | United States |
| Bellus Health Investigational Site #44 | Chicoutimi | Quebec | G7H 7Y8 | Canada |
| Bellus Health Investigational Site #20 | Montreal | Quebec | H2X 2V1 | Canada |
| Bellus Health Investigational Site #43 | Québec | Quebec | G1N 4V3 | Canada |
| Bellus Health Investigational Site #39 | Québec | Quebec | G1W 4R4 | Canada |
| Bellus Health Investigational Site #42 | Sherbrooke | Quebec | J1L 0H8 | Canada |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000657411 | BLU-5937 |
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