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

A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma

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.

Study Overview

• Status: Terminated
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: Briquilimab; Other: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2R3
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • University of British Columbia
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University
  • Quebec
    • Québec, Quebec, Canada, G1V 0A6
      • University of Laval
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5A2
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo Comparator; Subcutaneous Administration
Experimental: Briquilimab	Drug: Briquilimab; Subcutaneous Administration; Other Names: JSP191

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants	Incidence and/or severity of AEs, treatmentemergent adverse events (TEAEs), SAEs, AEIs, and AEs leading to discontinuation. Incidence of clinically significant abnormal laboratory values and vital signs.	From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)
To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR	Allergen-induced LAR will be measured by maximum percentage fall in FEV1 during the period 3-7 hours after the allergen challenge and compared between briquilimab and placebo at week 6.	3-7 hours after allergen challenge between Briquilimab and Placebo at week 6
To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR	Allergen-induced LAR will be measured by area under the FEV1 time-response curve [AUC] during the period 3-7 hours after the allergen challenge and compared between briquilimab and placebo at week 6.	3-7 hours after allergen challenge between Briquilimab and Placebo at week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.	Allergen-induced EAR will be measured by maximum percentage fall in FEV1 during the period 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6.	0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6
To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.	Allergen-induced EAR will be measured by area under the FEV1 time-response curve [AUC] during the period 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6.	0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6
Comparison of allergen-induced inflammatory mediators at 7h and 24h post allergen, between briquilimab and placebo	Changes from pre-allergen challenge sputum inflammatory mediators to 7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6.	7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6.
Comparison of the allergen-induced shift in AHR to methacholine at 24 hours after the allergen challenge, between briquilimab and placebo.	Changes from pre-allergen challenge AHR to 24 hours after the allergen challenge assessed by methacholine PD20, and compared between briquilimab and placebo at week 6.	24 hours after the allergen challenge compared between briquilimab and placebo at week 6.
Comparison of the allergen-induced changes in sputum leukocytes at 7h and 24h post allergen challenge, between the briquilimab and placebo.	Changes from pre-allergen challenge sputum leukocytes to 7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6.	7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.

Collaborators and Investigators

• Sponsor: Jasper Therapeutics, Inc.
• Investigators: Study Director: Medical Director, Jasper Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Actual): August 11, 2025
• Study Completion (Actual): August 11, 2025

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Allergy; Lung Diseases; Exacerbation; Chronic Disease; Lung Function; Respiratory Hypersensitivity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Lung Diseases, Obstructive; Asthma; Hypersensitivity; Respiratory Tract Diseases; Immune System Diseases; Chronic Disease; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: JSP-CP-012; 2024-516164-28-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No