Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 5:50 AM
Study NCT ID:
NCT04538794
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Sponsor:
Celldex Therapeutics
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Detailed Description:
The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.
There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.
There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-005426-29 | EUDRACT_NUMBER | None | View |