Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Briquilimab · 1 trial · 1 indication
Incidence and severity of treatment emergent AEs/SAEs
| Arm | Type | Description |
|---|---|---|
| Briquilimab | EXPERIMENTAL | This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled. |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator |
| Name | Type | Description |
|---|---|---|
| Briquilimab | DRUG | Subcutaneous Administration |
| Placebo | OTHER | Placebo Comparator |
Inclusion Criteria: 1. Written informed consent after the nature of the trial has been fully explained and before performing any trial related assessments 2. Males and females, ≥18 years old 3. i. For Cohorts 1, 2, 3, 4a, 4b, 5, 5b, 6 and 7: Diagnosis of symptomatic CSU despite treatment as defined...
Briquilimab is an investigational monoclonal antibody being developed for chronic spontaneous urticaria, a dermatologic condition marked by recurring hives without an identifiable trigger. It is also associated with orphan drug and rare pediatric disease designations. It is not yet approved for any indication and remains in clinical development.
Briquilimab is developed by Jasper Therapeutics, Inc., which trades under the ticker JSPR. The company is the sponsor of the clinical program evaluating the drug in chronic spontaneous urticaria.
Briquilimab is in Phase 1 development. The program includes one completed Phase 1 trial in chronic spontaneous urticaria, and no active trials are currently listed. It is investigational and has not been approved by the FDA for any use.
Briquilimab has been studied in a single Phase 1 trial, NCT06162728, titled a dose escalation trial of safety, pharmacokinetic and pharmacodynamic and preliminary clinical activity in adults with chronic spontaneous urticaria. The trial enrolled 87 participants across the United States and Germany and is completed.
No, Briquilimab is not FDA approved. It is an investigational monoclonal antibody still in clinical development, with one completed Phase 1 trial in chronic spontaneous urticaria. It holds orphan drug and rare pediatric disease designations, which are separate from marketing approval.
The Phase 1 trial NCT06162728 was randomized, double blind, and placebo controlled, enrolling 87 adults aged 18 years and older of all sexes. It was conducted in the United States and Germany and did not include healthy volunteers.