A Study of Barzolvolimab in Patients With Prurigo Nodularis

Celldex Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Prurigo Nodularis

Treatments: Other: Matching Placebo; Biological: barzolvolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06366750

2023-510279-80-00 (Other Identifier)

CDX0159-10

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

Full description

The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis.

There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. Participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Males and females, ≥18 years of age.

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 for stage of chronic nodular prurigo (IGA-CNPG-S) 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) once or twice a day 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 PN lesions limited to small area on one side of the body (e.g., only one arm affected).
3. Active unstable pruritic skin conditions in addition to PN.
4. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
5. Females who are pregnant or nursing.
6. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
7. 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.
8. History of anaphylaxis.
9. Prior receipt of barzolvolimab

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: Quadruple Blind

---

120 participants in 3 patient groups, including a placebo group

Barzolvolimab 450 mg, then 150 mg Q4W

Experimental group

Description:

450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Treatment:

Biological: barzolvolimab

Barzolvolimab 450 mg, then 300 mg Q4W

Experimental group

Description:

450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Treatment:

Biological: barzolvolimab

Placebo

Placebo Comparator group

Description:

Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Treatment:

Other: Matching Placebo