A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants with Allergic Asthma
Allergic AsthmaStudy 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 to 65
Participation Criteria
Inclusion Criteria:
* Men and women 18 to 65 years of age; stable, allergic asthma; history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value; able to comprehend and follow all required 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); and positive skin-prick test and positive allergen-induced early and late airway bronchoconstriction to common aeroallergens.
Exclusion Criteria:
* Worsening of asthma or respiratory infection in the preceding 6 weeks; lung disease other 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 for relief of symptoms but prophylactic use for exercise is allowed as-needed); pregnant or lactating women; and women actively seeking pregnancy or who are not using adequate contraception.
Study Location
McMaster University
McMaster UniversityHamilton, Ontario
Canada
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University of British Columbia
University of British ColumbiaVancouver, British Columbia
Canada
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Celine Bergeron, MD
University of Calgary
University of CalgaryCalgary, Alberta
Canada
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Richard Leigh, MD
University of Laval
University of LavalQuebec City, Quebec
Canada
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Andreanne Cote, MD
University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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University of Saskatchewan
University of SaskatchewanSaskatoon, Saskatchewan
Canada
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Brianne Philipenko, MD
- Study Sponsored By
- Jasper Therapeutics, Inc.
- Participants Required
- More Information
- Study ID:
NCT06592768