Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-01 @ 2:31 PM
Study NCT ID:
NCT06592768
Status:
TERMINATED
Last Update Posted:
2025-09-16
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants', 'timeFrame': 'From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)', 'description': 'Incidence and/or severity of AEs, treatmentemergent adverse events (TEAEs), SAEs, AEIs, and AEs leading to discontinuation.\n\nIncidence of clinically significant abnormal laboratory values and vital signs.'}, {'measure': 'To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR', 'timeFrame': '3-7 hours after allergen challenge between Briquilimab and Placebo at week 6', 'description': '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.'}, {'measure': 'To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR', 'timeFrame': '3-7 hours after allergen challenge between Briquilimab and Placebo at week 6', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.', 'timeFrame': '0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6', 'description': '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.'}, {'measure': 'To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.', 'timeFrame': '0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6', 'description': '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.'}, {'measure': 'Comparison of allergen-induced inflammatory mediators at 7h and 24h post allergen, between briquilimab and placebo', 'timeFrame': '7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6.', 'description': '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.'}, {'measure': 'Comparison of the allergen-induced shift in AHR to methacholine at 24 hours after the allergen challenge, between briquilimab and placebo.', 'timeFrame': '24 hours after the allergen challenge compared between briquilimab and placebo at week 6.', 'description': '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.'}, {'measure': 'Comparison of the allergen-induced changes in sputum leukocytes at 7h and 24h post allergen challenge, between the briquilimab and placebo.', 'timeFrame': '7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Allergic Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT06592768', 'briefTitle': 'A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jasper Therapeutics, Inc.'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma', 'orgStudyIdInfo': {'id': 'JSP-CP-012'}, 'secondaryIdInfos': [{'id': '2024-516164-28-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Briquilimab', 'interventionNames': ['Drug: Briquilimab']}], 'interventions': [{'name': 'Briquilimab', 'type': 'DRUG', 'otherNames': ['JSP191'], 'description': 'Subcutaneous Administration', 'armGroupLabels': ['Briquilimab']}, {'name': 'Placebo Comparator', 'type': 'OTHER', 'description': 'Subcutaneous Administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2R3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6T 1Z4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N 5A2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jasper Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jasper Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}