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NCT05405660 · ClinicalTrials.gov registry record · Phase 2
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
A Phase 2 study of Chronic Inducible Urticaria, sponsored by Celldex Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
- 20
- Study locations
NCT05405660: Completed Phase 2 study of Chronic Inducible Urticaria, sponsored by Celldex Therapeutics.
NCT05405660 is a Phase 2 study of Chronic Inducible Urticaria that has completed, run by Celldex Therapeutics. The registered enrollment target is 196 participants, roughly in line with the 185-participant average among 4 other Chronic Inducible Urticaria trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05405660, a Phase 2 study of Chronic Inducible Urticaria, has completed, sponsored by Celldex Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.
Primary Outcome
Percentage of patients with a negative provocation test for Cold Inducible Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) at week 12 * For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
Conditions Studied
Interventions
- DRUG Matching Placebo
- BIOLOGICAL barzolvolimab
Study Locations (20)
Other
- Outpatient Clinic for Individual Practice for Specialized Outpatient - Razgrad
- Medical Center Iskar- EOOD Office of Clinical Allergology - Sofia
- "Medical Center Ekselsior" OOD - Sofia
- "University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology - Sofia
Alabama
- Clinical Research Center of Alabama - Birmingham
- Allervie Clinical Research - Montgomery
California
- Kern Research, Inc - Bakersfield
- Allergy & Asthma Consultants - Redwood City
Arizona
- One of a Kind Clinical Research Center, LLC - Paradise Valley
Arkansas
- Little Rock Allergy & Asthma CRC - Little Rock
Colorado
- IMMUNOe Research Centers - Centennial
Florida
- Sarasota Clinical Research - Sarasota
Idaho
- Treasure Valley Medical Research - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2025-09-12 |
| Phase | Phase 2 |
What the finished NCT05405660 record still lists
NCT05405660 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 185-participant average among 4 other Chronic Inducible Urticaria trials with a reported enrollment target.
The record links to 1 condition, with Chronic Inducible Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.
NCT05405660 names 20 study sites across 15 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT05405660 about?
NCT05405660 is a clinical study titled "A Study of CDX-0159 in Patients With Chronic Inducible Urticaria". The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.
What is the current status of trial NCT05405660?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2022-06-28. Estimated completion is 2025-09-12.
What conditions does trial NCT05405660 study?
This clinical trial studies the following conditions: Chronic Inducible Urticaria.
What interventions are being tested in trial NCT05405660?
The interventions under investigation include: Matching Placebo (DRUG), barzolvolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05405660?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05405660 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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