Clinical trial NCT04693195: A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pruritus
Atopic Dermatitis
Keywords: BLU-5937
Chronic Pruritus
Atopic Dermatitis
P2X3 receptor antagonist
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
timeFrame: Week 4
Secondary outcomes:
measure: Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
timeFrame: Week 4
measure: Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score
timeFrame: Week 4
measure: Change from baseline in Itching Quality of Life Survey (ItchyQOL)
timeFrame: Week 4
measure: Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire
timeFrame: Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Bellus Health Investigational Site #28
state: Arizona
city: Scottsdale
country: United States
facility: Bellus Health Investigational Site #10
state: Arizona
city: Beverly Hills
country: United States
facility: Bellus Health Investigational Site #23
state: California
city: Encinitas
country: United States
facility: Bellus Health Investigational Site #33
state: California
city: Fountain Valley
country: United States
facility: Bellus Health Investigational Site #27
state: California
city: San Diego
country: United States
facility: Bellus Health Investigational Site #35
state: California
city: Hialeah
country: United States
facility: Bellus Health Investigational Site #15
state: Florida
city: Margate
country: United States
facility: Bellus Health Investigational Site #32
state: Florida
city: Miami
country: United States
facility: Bellus Health Investigational Site #16
state: Florida
city: Miami
country: United States
facility: Bellus Health Investigational Site #19
state: Florida
city: Sweetwater
country: United States
facility: Bellus Health Investigational Site #17
state: Florida
city: Savannah
country: United States
facility: Bellus Health Investigational Site #24
state: Georgia
city: Owensboro
country: United States
facility: Bellus Health Investigational Site #13
state: Kentucky
city: Baton Rouge
country: United States
facility: Bellus Health Investigational Site #38
state: Louisiana
city: Covington
country: United States
facility: Bellus Health Investigational Site #45
state: Louisiana
city: New Orleans
country: United States
facility: Bellus Health Investigational Site #18
state: Louisiana
city: Minneapolis
country: United States
facility: Bellus Health Investigational Site #36
state: Minnesota
city: Portsmouth
country: United States
facility: Bellus Health Investigational Site #22
state: New Hampshire
city: New York
country: United States
facility: Bellus Health Investigational Site #34
state: New York
city: High Point
country: United States
facility: Bellus Health Investigational Site #14
state: North Carolina
city: Norman
country: United States
facility: Bellus Health Investigational Site #29
state: Oklahoma
city: Newtown Square
country: United States
facility: Bellus Health Investigational Site #37
state: Pennsylvania
city: Rapid City
country: United States
facility: Bellus Health Investigational Site #41
state: South Dakota
city: Austin
country: United States
facility: Bellus Health Investigational Site #12
state: Texas
city: College Station
country: United States
facility: Bellus Health Investigational Site #31
state: Texas
city: San Antonio
country: United States
facility: Bellus Health Investigational Site #40
state: Texas
city: San Antonio
country: United States
facility: Bellus Health Investigational Site #11
state: Texas
city: Seattle
country: United States
facility: Bellus Health Investigational Site #25
state: Washington
city: Chicoutimi
country: Canada
facility: Bellus Health Investigational Site #44
state: Quebec
city: Montreal
country: Canada
facility: Bellus Health Investigational Site #20
state: Quebec
city: Quebec City
country: Canada
facility: Bellus Health Investigational Site #43
state: Quebec
city: Quebec city
country: Canada
facility: Bellus Health Investigational Site #39
state: Quebec
city: Sherbrooke
country: Canada
facility: Bellus Health Investigational Site #42
state: Quebec
Study officials:
References: