A Study of CDX-0159 in Patients With Prurigo Nodularis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prurigo Nodularis

Intervention / Treatment
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* Biological: CDX-0159
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Key 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. Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDX-0159 1.5mg/kg<br>CDX-0159 1.5mg/kg administered once | Biological: CDX-0159<br>* administered intravenously<br>* Other names: barzolvolimab;|
| Experimental: CDX-0159 3mg/kg<br>CDX-0159 3.0 mg/kg administered once | Biological: CDX-0159<br>* administered intravenously<br>* Other names: barzolvolimab;|
| Placebo Comparator: Placebo<br>Normal saline administered once | Drug: Normal saline<br>* administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by the incidence and severity of adverse events | Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events | From Day 1 (first dose) to Day 169 (last follow-up visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic evaluation | CDX-0159 serum concentrations will be measured at specified visits | From Day 1 (before first dose) to Day 169 (last follow-up visit) | 
| Clinical effect of CDX-0159 on pruritus | The mean percent change from baseline to Week 8 in the weekly average score of worst intensity itch per a numeric rating scale. The Worst Itch-Numerical Rating Scale (WI-NRS) ranges from 0 = no itch to 10 =worst imaginable itch for their worst intensity prurigo nodularis itch in the preceding 24-hr period. | From Day 1 (first dose) to Day 57 (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDX-0159, barzolvolimab