A Study of CDX-0159 in Patients With Prurigo Nodularis

Celldex Therapeutics

Status and phase: Completed; Phase 1

Conditions: Prurigo Nodularis

Treatments: Drug: Normal saline; Biological: CDX-0159

Study type: Interventional

Funder types: Industry

Identifiers

NCT04944862

CDX0159-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Males and females, 18 - 75 years old.

2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:

   1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
   2. An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).

3. 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.

4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.

5. Willing to apply a topical moisturizer (emollient) twice daily throughout the study.

6. 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.

7. 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:

1. PN due to neuropathy, psychiatric disorders or medications.
2. Unilateral lesions of prurigo (eg, only one arm affected)
3. Active unstable pruritic skin conditions in addition to PN.
4. Women who are pregnant or nursing.
5. Known hepatitis B or hepatitis C infection or active COVID-19 infection
6. 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.
7. History of anaphylaxis.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

CDX-0159 1.5mg/kg

Experimental group

Description:

CDX-0159 1.5mg/kg administered once

Treatment:

Biological: CDX-0159

CDX-0159 3mg/kg

Experimental group

Description:

CDX-0159 3.0 mg/kg administered once

Treatment:

Biological: CDX-0159

Placebo

Placebo Comparator group

Description:

Normal saline administered once

Treatment:

Drug: Normal saline