Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162728
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-21
Brief Title:
Dose Escalation Trial Of Safety PharmacokineticPharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria CSU
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 Spontaneous Urticaria CSU Who Remain Symptomatic Despite Treatment With Or Who Cannot Tolerate Omalizumab
Status:
RECRUITING
Status Verified Date:
2024-08
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:
BEACON
Brief Summary:
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
The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria CSU who remain symptomatic despite treatment with H1 antihistamines and omalizumab Additionally pharmacokinetic PK properties of briquilimab and other pharmacodynamic PD parameters such as effects on mast cells MC serum tryptase levels and on allergic skin reactivity will be investigated
The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria CSU who remain symptomatic despite treatment with H1 antihistamines and omalizumab Additionally pharmacokinetic PK properties of briquilimab and other pharmacodynamic PD parameters such as effects on mast cells MC serum tryptase levels and on allergic skin reactivity will be investigated
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505446-25 | EUDRACT_NUMBER | None | None |