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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517830-17-00 | EU Trial (CTIS) Number |
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Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.
This is a Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial, specifically the BEACON (JSP-CP-011) and SPOTLIGHT (JSP CP-010) trials (referred to as "parent studies") and future CU trials sponsored by Jasper Therapeutics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Briquilimab | Experimental | Briquilimab via SQ injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Briquilimab | Drug | No additional details needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of briquilimab | Incidence and severity of AEs including SAEs, TEAEs and AEIs. | From signing the informed consent form through study completion (an average of one year) |
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Inclusion Criteria:
Provides informed written consent.
Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
Disease specific eligibility:
The laboratory parameters to be within the acceptable range as follows:
Participants willing to abstain from blood donations while being on the trial (Screening to end of trial [EOT]).
Male participants (who are not vasectomized) who are heterosexually active must use highly effective contraceptive methods and must abstain from sperm donation during the trial and for at least 8 months after the last dose of briquilimab. A male participant is considered vasectomized if he had a vasectomy at least 4 months prior to Screening and if he has received post-surgical medical assessment of the surgical success of the vasectomy
Female participants of childbearing potential who are heterosexually active (defined in Section 5.2.1.1) must use highly effective contraceptive methods (Section 5.2.1) during the trial and for at least 90 days after the last dose of briquilimab. Female participants of non-childbearing potential must be surgically sterile (i.e., had undergone complete hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or be in a menopausal state (at least 1 year without menses).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Jasper Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 118 | Birmingham | Alabama | 35244 | United States | ||
| Investigative Site 108 |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Investigative Site 105 | San Diego | California | 92123 | United States |
| Investigative Site 116 | Tampa | Florida | 33613 | United States |
| Investigative Site 109 | Boise | Idaho | 83706 | United States |
| Investigative Site 124 | Normal | Illinois | 61761 | United States |
| Investigative Site 110 | Indianapolis | Indiana | 46250 | United States |
| Investigative Site 123 | Lafayette | Louisiana | 70508 | United States |
| Investigative Site 101 | Baltimore | Maryland | 21224 | United States |
| Investigative Site 121 | White Marsh | Maryland | 21162 | United States |
| Investigative Site 103 | Cincinnati | Ohio | 45236 | United States |
| Investigative Site 111 | Murray | Utah | 84107 | United States |
| Investigative Site 115 | Seattle | Washington | 98101 | United States |
| Investigative Site 210 | München | Bavaria | 80802 | Germany |
| Investigative Site 202 | Marburg | Hesse | 35043 | Germany |
| Investigative Site 204 | Münster | North Rhine-Westphalia | 48149 | Germany |
| Investigative Site 209 | Dresden | Saxony | 01307 | Germany |
| Investigative Site 206 | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Investigative Site 201 | Berlin | 12203 | Germany |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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