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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Celldex Therapeutics
- Enrollment
- 24
- Locations
- 17
- Primary Endpoint
- Safety and tolerability as assessed by the incidence and severity of adverse events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females, 18 - 75 years old.
- •Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
- •At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
- •An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).
- •Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
- •Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
- •Willing to apply a topical moisturizer (emollient) twice daily throughout the study.
- •Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
- •Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Exclusion Criteria
- •PN due to neuropathy, psychiatric disorders or medications.
- •Unilateral lesions of prurigo (eg, only one arm affected)
- •Active unstable pruritic skin conditions in addition to PN.
- •Women who are pregnant or nursing.
- •Known hepatitis B or hepatitis C infection or active COVID-19 infection
- •Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
- •History of anaphylaxis.
- •There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Arms & Interventions
CDX-0159 1.5mg/kg
CDX-0159 1.5mg/kg administered once
Intervention: CDX-0159 (Biological)
CDX-0159 3mg/kg
CDX-0159 3.0 mg/kg administered once
Intervention: CDX-0159 (Biological)
Placebo
Normal saline administered once
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Safety and tolerability as assessed by the incidence and severity of adverse events
Time Frame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events
Secondary Outcomes
- Pharmacokinetic evaluation(From Day 1 (before first dose) to Day 169 (last follow-up visit))
- Clinical effect of CDX-0159 on pruritus(From Day 1 (first dose) to Day 57 (week 8))