A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants with Allergic Asthma

Last updated: March 24, 2025
Sponsor: Jasper Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Allergy (Pediatric)

Asthma

Treatment

Briquilimab

Placebo Comparator

Clinical Study ID

NCT06592768
JSP-CP-012
2024-516164-28-00
  • Ages 18-65
  • All Genders

Study Summary

Study JSP-CP-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. A single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women 18 to 65 years of age; stable, allergic asthma; history of episodicwheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) atbaseline at least 70% of the predicted value; able to comprehend and follow allrequired study procedures; willing and able to sign an informed consent form;positive methacholine challenge at baseline (concentration of methacholine causing 20% decrease in FEV1 [PC20] PC20 ≤ 16 mg/mL or PD20 equivalent to ≤400µg); andpositive skin-prick test and positive allergen-induced early and late airwaybronchoconstriction to common aeroallergens.

Exclusion

Exclusion Criteria:

  • Worsening of asthma or respiratory infection in the preceding 6 weeks; lung diseaseother than allergic asthma; prior treatment with a c-Kit inhibiting therapy;anaphylaxis to any parenterally administered biologics; use of asthma medications (note: intermittent doses of short-acting β2-agonist are allowed once weekly forrelief of symptoms but prophylactic use for exercise is allowed as-needed); pregnantor lactating women; and women actively seeking pregnancy or who are not usingadequate contraception.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Briquilimab
Phase: 1
Study Start date:
November 26, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 1N4
    Canada

    Active - Recruiting

  • University of Alberta

    Edmonton, Alberta T6G 2R3
    Canada

    Active - Recruiting

  • University of British Columbia

    Vancouver, British Columbia V6T 1Z4
    Canada

    Active - Recruiting

  • McMaster University

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • University of Laval

    Quebec City, Quebec G1V 0A6
    Canada

    Active - Recruiting

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N 5A2
    Canada

    Active - Recruiting

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