A Study of CDX-0159 in Patients With Prurigo Nodularis

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Celldex Therapeutics

Trial Summary

What is the purpose of this trial?

The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

Research Team

Eligibility Criteria

Inclusion Criteria

- An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1)

- Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule

You have at least 20 small bumps on both arms, both legs, or both sides of your trunk during the initial evaluation.

Exclusion Criteria

Women who are pregnant or nursing

Known hepatitis B or hepatitis C infection or active COVID-19 infection

You have peripheral neuropathy caused by nerve damage, psychiatric disorders, or you are taking certain medications.

Treatment Details

Interventions

• CDX-0159 (Monoclonal Antibodies)

Participant Groups

Group I: CDX-0159 3mg/kg Experimental Treatment 2 Interventions

CDX-0159 3.0 mg/kg administered once

Group II: CDX-0159 1.5mg/kg Experimental Treatment 1 Intervention

CDX-0159 1.5mg/kg administered once

Group III: Placebo Placebo Group 1 Intervention

Normal saline administered once

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Optiskin New York, NY

Desert Sky Dermatology Tempe, AZ

University of New Mexico Albuquerque, NM

Markowitz Medical/Optiskin New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

Celldex Therapeutics

Lead Sponsor

Trials

66

Patients Recruited

5,900+