A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

Celldex Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Inducible Urticaria

Treatments: Drug: Matching Placebo; Biological: barzolvolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05405660

2021-006447-95 (EudraCT Number)

CDX0159-07

Details and patient eligibility

About

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Full description

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria [ColdU] or Symptomatic Dermographism [SD]) who remain symptomatic despite the use of H1-antihistamines.

There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Enrollment: 196 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 chronic ColdU or SD >/= 3 months.

3. Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

   1. Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment and agree to stay on through trial.
   3. UCT < 12 during the 14 days prior to treatment.

4. Positive provocation test

   1. for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3)
   2. for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)

5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.

6. Willing and able to complete a daily symptom electronic diary and comply with study visits.

Key exclusion criteria:

1. Women who are pregnant or nursing.
2. Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments.
3. Active, pruritic skin condition in addition to CIndU.
4. Medical condition that would cause additional risk or interfere with study procedures.
5. Known active HIV, hepatitis B or hepatitis C infection.
6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
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: Quadruple Blind

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196 participants in 6 patient groups, including a placebo group

barzolvolimab 150 mg in patients with Symptomatic Dermographism

Experimental group

Description:

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

Treatment:

Biological: barzolvolimab

barzolvolimab 300 mg in patients with Symptomatic Dermographism

Experimental group

Description:

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Treatment:

Biological: barzolvolimab

Placebo Comparator in patients with Symptomatic Dermographism

Placebo Comparator group

Description:

Placebo injection subcutaneous every 4 weeks for 20 weeks

Treatment:

Drug: Matching Placebo

barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria

Experimental group

Description:

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

Treatment:

Biological: barzolvolimab

barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria

Experimental group

Description:

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Treatment:

Biological: barzolvolimab

Placebo Comparator in patients with Chronic Inducible Cold Urticaria

Placebo Comparator group

Description:

Placebo injection subcutaneous every 4 weeks for 20 weeks

Treatment:

Drug: Matching Placebo