Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353971
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-03
Brief Title:
A Dose Escalation Trial of Safety PharmacokineticPharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria CIndU Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Sponsor:
Jasper Therapeutics Inc
Organization:
Jasper Therapeutics Inc
Study Overview
Official Title:
A Phase 1b2a Dose Escalation Trial of Safety PharmacokineticPharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria CIndU Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPOTLIGHT
Brief Summary:
This is an open-label single ascending dose Phase 1b2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria ColdU or Symptomatic Dermographism SD who remain symptomatic despite treatment with H1 antihistamines The trial will explore two ascending dose levels which will be tested in two sequential cohorts
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507534-24 | EUDRACT_NUMBER | None | None |