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NCT05368285 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
A Phase 2 study, sponsored by Celldex Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
NCT05368285: Completed Phase 2 study, sponsored by Celldex Therapeutics.
NCT05368285 is a Phase 2 study that has completed, run by Celldex Therapeutics. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05368285, a Phase 2 study, has completed, sponsored by Celldex Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
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 Spontaneous Urticaria
Primary Outcome
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None 1. = mild (present, but not annoying or troublesome) 2. = moderate (troublesome, but does not interfere with normal daily activity or sleep) 3. = intense (severe itch,
Interventions
- DRUG Matching Placebo
- BIOLOGICAL barzolvolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2024-12-20 |
| Phase | Phase 2 |
What the finished NCT05368285 record still lists
NCT05368285 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT05368285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05368285 about?
NCT05368285 is a clinical study titled "A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous 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 Spontaneous Urticaria
What is the current status of trial NCT05368285?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2022-05-19. Estimated completion is 2024-12-20.
What interventions are being tested in trial NCT05368285?
The interventions under investigation include: Matching Placebo (DRUG), barzolvolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05368285?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05368285's enrollment target sits among peer trials
208 294th of 2000 higher than 1,704 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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