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

Last updated: October 13, 2022
Sponsor: Bellus Health Inc
Overall Status: Completed

Phase

2

Condition

Dermatitis, Atopic

Allergy

Rash

Treatment

N/A

Clinical Study ID

NCT04693195
CL-PR-5937-01
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 contraceptivemethod during the study and until at least 4 weeks after the last study drugadministration

Exclusion

Exclusion Criteria:

  • History of skin disease or presence of skin condition that would interfere with thestudy assessments
  • Clearly defined etiology for pruritus other than AD, including but not limited to:urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renaldisease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, andinfection
  • Presence of any acute skin condition other than AD which may risk inducing a pruritusflare/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 ofsuccessfully treated nonmetastatic cutaneous squamous cell or basal cell carcinomaand/or localized carcinoma in situ of the cervix
  • Known history of, or active, parasitic infection, including skin parasites such asscabies within 12 months prior to Screening
  • Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or humanimmunodeficiency virus [HIV])
  • Known history of clinically significant drug or alcohol abuse in the last year
  • Previous participation in a BLU-5937 trial

Study Design

Total Participants: 142
Study Start date:
December 09, 2020
Estimated Completion Date:
October 12, 2021

Study 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.

Connect with a study center

  • Bellus Health Investigational Site #44

    Chicoutimi, Quebec G7H 7Y8
    Canada

    Site Not Available

  • Bellus Health Investigational Site #20

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Bellus Health Investigational Site #43

    Quebec City, Quebec G1N 4V3
    Canada

    Site Not Available

  • Bellus Health Investigational Site #39

    Quebec city, Quebec G1W 4R4
    Canada

    Site Not Available

  • Bellus Health Investigational Site #42

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Bellus Health Investigational Site #28

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Bellus Health Investigational Site #10

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Bellus Health Investigational Site #23

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Bellus Health Investigational Site #33

    Encinitas, California 92024
    United States

    Site Not Available

  • Bellus Health Investigational Site #27

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Bellus Health Investigational Site #35

    San Diego, California 92123
    United States

    Site Not Available

  • Bellus Health Investigational Site #15

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Bellus Health Investigational Site #32

    Margate, Florida 33063
    United States

    Site Not Available

  • Bellus Health Investigational Site #16

    Miami, Florida 33125
    United States

    Site Not Available

  • Bellus Health Investigational Site #19

    Miami, Florida 33136
    United States

    Site Not Available

  • Bellus Health Investigational Site #17

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Bellus Health Investigational Site #24

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Bellus Health Investigational Site #13

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Bellus Health Investigational Site #38

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Bellus Health Investigational Site #45

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Bellus Health Investigational Site #18

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Bellus Health Investigational Site #36

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Bellus Health Investigational Site #22

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Bellus Health Investigational Site #34

    New York, New York 10075
    United States

    Site Not Available

  • Bellus Health Investigational Site #14

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Bellus Health Investigational Site #29

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Bellus Health Investigational Site #37

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Bellus Health Investigational Site #41

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Bellus Health Investigational Site #12

    Austin, Texas 78759
    United States

    Site Not Available

  • Bellus Health Investigational Site #31

    College Station, Texas 77845
    United States

    Site Not Available

  • Bellus Health Investigational Site #11

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Bellus Health Investigational Site #40

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Bellus Health Investigational Site #25

    Seattle, Washington 98101
    United States

    Site Not Available

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