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

NCT04693195 | Completed Phase 2 FDA Drug

• 1 other identifier: CL-PR-5937-01
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 33

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).

Conditions

Chronic Pruritus; Atopic Dermatitis

Keywords

BLU-5937; Chronic Pruritus; Atopic Dermatitis; P2X3 receptor antagonist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score

  Week 4

• Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score

  Week 4

• Change from baseline in Itching Quality of Life Survey (ItchyQOL)

  Week 4

• Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire

  Week 4

Study Arms (2)

BLU-5937 oral tablet

EXPERIMENTAL

Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.

Drug: BLU-5937

Placebo oral tablet

PLACEBO COMPARATOR

Eligible participants will receive matching Placebo BID orally for 4 weeks.

Drug: Placebo

Interventions

BLU-5937 DRUG

Oral administration of BLU-5937 tablets

BLU-5937 oral tablet

Placebo DRUG

Oral administration of matching placebo for BLU-5937 tablets

Placebo oral tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (33)

Bellus Health Investigational Site #28

Phoenix, Arizona, 85032, United States

Location

Bellus Health Investigational Site #10

Scottsdale, Arizona, 85254, United States

Location

Bellus Health Investigational Site #23

Beverly Hills, California, 90212, United States

Location

Bellus Health Investigational Site #33

Encinitas, California, 92024, United States

Location

Bellus Health Investigational Site #27

Fountain Valley, California, 92708, United States

Location

Bellus Health Investigational Site #35

San Diego, California, 92123, United States

Location

Bellus Health Investigational Site #15

Hialeah, Florida, 33012, United States

Location

Bellus Health Investigational Site #32

Margate, Florida, 33063, United States

Location

Bellus Health Investigational Site #16

Miami, Florida, 33125, United States

Location

Bellus Health Investigational Site #19

Miami, Florida, 33136, United States

Location

Bellus Health Investigational Site #17

Sweetwater, Florida, 33172, United States

Location

Bellus Health Investigational Site #24

Savannah, Georgia, 31406, United States

Location

Bellus Health Investigational Site #13

Owensboro, Kentucky, 42301, United States

Location

Bellus Health Investigational Site #38

Baton Rouge, Louisiana, 70809, United States

Location

Bellus Health Investigational Site #45

Covington, Louisiana, 70433, United States

Location

Bellus Health Investigational Site #18

New Orleans, Louisiana, 70115, United States

Location

Bellus Health Investigational Site #36

Minneapolis, Minnesota, 55402, United States

Location

Bellus Health Investigational Site #22

Portsmouth, New Hampshire, 03801, United States

Location

Bellus Health Investigational Site #34

New York, New York, 10075, United States

Location

Bellus Health Investigational Site #14

High Point, North Carolina, 27262, United States

Location

Bellus Health Investigational Site #29

Norman, Oklahoma, 73071, United States

Location

Bellus Health Investigational Site #37

Newtown Square, Pennsylvania, 19073, United States

Location

Bellus Health Investigational Site #41

Rapid City, South Dakota, 57702, United States

Location

Bellus Health Investigational Site #12

Austin, Texas, 78759, United States

Location

Bellus Health Investigational Site #31

College Station, Texas, 77845, United States

Location

Bellus Health Investigational Site #40

San Antonio, Texas, 78213, United States

Location

Bellus Health Investigational Site #11

San Antonio, Texas, 78229, United States

Location

Bellus Health Investigational Site #25

Seattle, Washington, 98101, United States

Location

Bellus Health Investigational Site #44

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

Bellus Health Investigational Site #20

Montreal, Quebec, H2X 2V1, Canada

Location

Bellus Health Investigational Site #43

Québec, Quebec, G1N 4V3, Canada

Location

Bellus Health Investigational Site #39

Québec, Quebec, G1W 4R4, Canada

Location

Bellus Health Investigational Site #42

Sherbrooke, Quebec, J1L 0H8, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

BLU-5937

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel assignment

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: December 9, 2020
• Primary Completion: October 4, 2021
• Study Completion: October 12, 2021
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (28)