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

NCT06592768 | Terminated Phase 1

• 2 other identifiers: JSP-CP-0122024-516164-28-00
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Allergic Asthma

Keywords

Asthma; Allergy; Chronic Disease; Lung Function; Exacerbation; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.

  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.

  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

  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.

  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.

  7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo Comparator

Briquilimab

EXPERIMENTAL

Drug: Briquilimab

Interventions

Briquilimab DRUG

Subcutaneous Administration

Also known as: JSP191

Briquilimab

Placebo Comparator OTHER

Subcutaneous Administration

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jasper Therapeutics, Inc.: lead

Study Sites (6)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

University of Laval

Québec, Quebec, G1V 0A6, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5A2, Canada

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity; Chronic Disease; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Jasper Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: This study is designed as a double-blind, placebo-controlled, parallel-group, randomized, study to evaluate the safety and efficacy of briquilimab on allergen-induced asthmatic airway responses.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: November 26, 2024
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)