Allergic AsthmaPhase 1NCT06592768
A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma
A Phase 1 study testing Briquilimab in people with Allergic Asthma, run by Jasper Therapeutics, Inc. at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Briquilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 6 sitesCanada
- Study dates
- 26 Nov 2024to 11 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Calgary
Calgary, Alberta, T2N 1N4
University of Alberta
Edmonton, Alberta, T6G 2R3
McMaster University
Hamilton, Ontario, L8N 3Z5
University of Laval
Québec, Quebec, G1V 0A6
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5A2
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: 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.
- Conditions
- Allergic Asthma
- Being tested
- Briquilimab, Placebo Comparator
- 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
- Medical subject headings
- Asthma, Hypersensitivity, Chronic Disease, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BriquilimabDrug
Also called JSP191
Subcutaneous Administration
Placebo ComparatorOther
Subcutaneous Administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator |
| Briquilimab | Experimental | Not described Receives: Drug: Briquilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Nov 2024
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Why it stopped: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Jasper Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592768
- Sponsor's protocol ID
- JSP-CP-012
- Other IDs
- 2024-516164-28-00
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma
- ClinicalTrials.gov ID
- NCT06592768
- Acronym / sponsor ID
- JSP-CP-012
- Conditions
- Allergic Asthma
- Keywords
- Asthma, Allergy, Chronic Disease, Lung Function, Exacerbation, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jasper Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo Comparator |
| Briquilimab | Experimental | Drug: Briquilimab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BriquilimabAlso: JSP191Subcutaneous Administration | Drug | Briquilimab |
| Placebo ComparatorSubcutaneous Administration | Other | Placebo |
Primary outcome
To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants
Time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)
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.
To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR
Time frame: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6
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.
To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR
Time frame: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6
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.
5 secondary outcomes
To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.
Results and safety
The study was stopped early (reason given: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Jasper Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Briquilimab in people with Allergic Asthma, run by Jasper Therapeutics, Inc. at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants (time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.