A Study of Barzolvolimab in Patients With Atopic Dermatitis

Celldex Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: Barzolvolimab; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06727552

CDX0159-15

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis

Full description

This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis.

There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, 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 [Arm 1], 300 mg Q4W after an initial loading dose of 450 mg [Arm 2], or placebo Q4W [Arm 3]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab 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. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 18 years of age

2. Diagnosis of chronic atopic dermatitis (AD) for at least 1 year

3. Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:

   1. EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
   2. Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
   3. IGA score ≥ 3 at Visit 1 and Visit 2
   4. Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment

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

5. 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

1. Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
2. Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
3. Planned or anticipated use of any prohibited medications at any time during the study.
4. Prior receipt of barzolvolimab or other anti-KIT therapy. 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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120 participants in 4 patient groups

Barzolvolimab 150 mg

Experimental group

Description:

Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks

Treatment:

Biological: Barzolvolimab

Barzolvolimab 300 mg

Experimental group

Description:

Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks

Treatment:

Biological: Barzolvolimab

Placebo then barzolvolimab 150 mg

Experimental group

Description:

Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks.

Treatment:

Drug: Matching placebo

Biological: Barzolvolimab

Placebo then barzolvolimab 300 mg

Experimental group

Description:

Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks.

Treatment:

Drug: Matching placebo

Biological: Barzolvolimab