Trials / Completed
CompletedNCT04944862
A Study of CDX-0159 in Patients With Prurigo Nodularis
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Clinical Effect of CDX-0159 in Patients With Prurigo Nodularis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Celldex Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.
Detailed description
The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis. There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. Patients will receive one dose of CDX-0159 (barzolvolimab) or placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CDX-0159 | administered intravenously |
| DRUG | Normal saline | administered intravenously |
Timeline
- Start date
- 2021-11-08
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2021-06-30
- Last updated
- 2023-08-14
Locations
17 sites across 3 countries: United States, Germany, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04944862. Inclusion in this directory is not an endorsement.