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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516164-28-00 | EU Trial (CTIS) Number |
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Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Briquilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Briquilimab | Drug | Subcutaneous Administration |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Jasper Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada | ||
| University of Alberta |
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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.
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| Placebo Comparator | Other | Subcutaneous Administration |
|
| 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. |
| Edmonton |
| Alberta |
| T6G 2R3 |
| Canada |
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada |
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
| University of Laval | Québec | Quebec | G1V 0A6 | Canada |
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 5A2 | Canada |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| D002908 | Chronic Disease |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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