Chronic Pruritus, Atopic Dermatitis
Conditions
Keywords
BLU-5937, Chronic Pruritus, Atopic Dermatitis, P2X3 receptor antagonist
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.
Interventions
DRUGBLU-5937
Oral administration of BLU-5937 tablets
DRUGPlacebo
Oral administration of matching placebo for BLU-5937 tablets
Sponsors
Bellus Health Inc. - a GSK company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Two-arm, parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Countries
Canada, United States
Outcome results
None listed