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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
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.
Time frame: Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4
Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire
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Bellus Health Investigational Site #28
Phoenix, Arizona, United States
Bellus Health Investigational Site #10
Scottsdale, Arizona, United States
Bellus Health Investigational Site #23
Beverly Hills, California, United States
Bellus Health Investigational Site #33
Encinitas, California, United States
Bellus Health Investigational Site #27
Fountain Valley, California, United States
Bellus Health Investigational Site #35
San Diego, California, United States
Bellus Health Investigational Site #15
Hialeah, Florida, United States
Bellus Health Investigational Site #32
Margate, Florida, United States
Bellus Health Investigational Site #16
Miami, Florida, United States
Bellus Health Investigational Site #19
Miami, Florida, United States
...and 23 more locations
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.
Time frame: Week 4