A Study of Barzolvolimab in Patients With Atopic Dermatitis

Last updated: April 7, 2025
Sponsor: Celldex Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Allergies & Asthma

Allergy

Treatment

Matching placebo

Barzolvolimab

Clinical Study ID

NCT06727552
CDX0159-15
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 withmoderate to severe AD as defined by:

  4. EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2

  5. Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2

  6. IGA score ≥ 3 at Visit 1 and Visit 2

  7. Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment

  8. Documented history of inadequate response to treatment with topical medications orfor whom topical medications are otherwise medically inadvisable.

  9. Willing and able to complete a daily symptom electronic diary for the duration ofthe study and adhere to the study visit schedule.

Exclusion

Exclusion Criteria:

  1. Any other active pruritic skin diseases that would confound AD assessments based onthe 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 thestudy.

  4. Prior receipt of barzolvolimab or other anti-KIT therapy. There are additionalcriteria that your study doctor will review with you to confirm you are eligible forthe study.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Matching placebo
Phase: 2
Study Start date:
January 07, 2025
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Advanced Dermatology Center

    Burbank, California 91506
    United States

    Active - Recruiting

  • Avance Trials

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Dynasty Dermatology

    Pasadena, California 91105
    United States

    Active - Recruiting

  • FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group

    Ventura, California 93003
    United States

    Active - Recruiting

  • International Dermatology Research Inc - Miami

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Windom Allergy, Asthma & Sinus

    Sarasota, Florida 34233
    United States

    Active - Recruiting

  • Atlanta Biomedical Clinical Research

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • OptiSkin Medical

    New York, New York 10128
    United States

    Active - Recruiting

  • Palmetto Clinical Trial Services LLC

    Simpsonville, South Carolina 29615
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Active - Recruiting

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