A Study of Barzolvolimab in Patients With Atopic Dermatitis

Last updated: February 6, 2026
Sponsor: Celldex Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Atopic Dermatitis

Rash

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: 131
Treatment Group(s): 2
Primary Treatment: Matching placebo
Phase: 2
Study Start date:
December 18, 2024
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

    Site Not Available

  • AllerVie Clinical Research

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Site Not Available

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham 4049979, Alabama 4829764 35244
    United States

    Site Not Available

  • Ohara Aivaz MD Dermatology

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Advanced Dermatology Center

    Burbank, California 91506
    United States

    Site Not Available

  • Avance Trials

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Site Not Available

  • Dynasty Dermatology

    Pasadena, California 91105
    United States

    Site Not Available

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

    Ventura, California 93003
    United States

    Site Not Available

  • Ohara Aivaz MD Dermatology

    Beverly Hills 5328041, California 5332921 90212
    United States

    Site Not Available

  • Advanced Dermatology Center - Burbank

    Burbank 5331835, California 5332921 91506
    United States

    Site Not Available

  • 310 Clinical Research

    Inglewood 5359488, California 5332921 90301
    United States

    Site Not Available

  • Avance Trials

    Laguna Niguel 5364329, California 5332921 92677
    United States

    Site Not Available

  • LA Universal Research Center, Inc.

    Los Angeles 5368361, California 5332921 90057
    United States

    Site Not Available

  • UCLA Division of Dermatology

    Los Angeles 5368361, California 5332921 90089
    United States

    Site Not Available

  • Dynasty Dermatology

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego 5391811, California 5332921 92120
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica 5393212, California 5332921 90404
    United States

    Site Not Available

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

    Ventura 5405878, California 5332921 93003
    United States

    Site Not Available

  • Pacific Clinical Innovations Inc.

    Vista 5406602, California 5332921 92083
    United States

    Site Not Available

  • Focus Clinical Research

    West Hills 8030162, California 5332921 91307
    United States

    Site Not Available

  • International Dermatology Research Inc - Miami

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Site Not Available

  • International Dermatology Research Inc - Miami

    Miami Lakes, Florida 33144
    United States

    Site Not Available

  • Windom Allergy, Asthma & Sinus

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Well Pharma Medical Research Corporation

    South Miami, Florida 33173
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah 4158476, Florida 4155751 33012
    United States

    Site Not Available

  • University of Miami

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • International Dermatology Research Inc - Miami

    Miami Lakes 4164186, Florida 4155751 33144
    United States

    Site Not Available

  • Sarasota Clinical Research

    Sarasota 4172131, Florida 4155751 34233
    United States

    Site Not Available

  • Well Pharma Medical Research Corporation

    South Miami 4173495, Florida 4155751 33173
    United States

    Site Not Available

  • Atlanta Biomedical Clinical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Lane Dermatology Research - Centricity - PPDS

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Georgia Skin and Cancer Clinic

    Savannah, Georgia 31419
    United States

    Site Not Available

  • Atlanta Biomedical Clinical Research

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Centricity Research Columbus Dermatology

    Columbus 4188985, Georgia 4197000 31904
    United States

    Site Not Available

  • Georgia Skin and Cancer Clinic

    Savannah 4221552, Georgia 4197000 31419
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Center for Medical Dermatology and Immunology Research

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Center for Medical Dermatology + Immunology Research

    Chicago 4887398, Illinois 4896861 60657
    United States

    Site Not Available

  • Sneeze Wheeze and Itch Associates LLC

    Normal 4903780, Illinois 4896861 61761
    United States

    Site Not Available

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Equity Medical LLC

    Bowling Green 4285268, Kentucky 6254925 42104
    United States

    Site Not Available

  • Allergy and Asthma Specialists PSC

    Owensboro 4303436, Kentucky 6254925 42301
    United States

    Site Not Available

  • Onyx Clinical Research - Michigan

    Flint, Michigan 48532
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Onyx Clinical Research - Michigan

    Flint 4992982, Michigan 5001836 48532
    United States

    Site Not Available

  • Derm Center

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Site Not Available

  • OptiSkin Medical

    New York, New York 10128
    United States

    Site Not Available

  • Equity Medical, LLC

    New York 5128581, New York 5128638 10023
    United States

    Site Not Available

  • OptiSkin Medical

    New York 5128581, New York 5128638 10128
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC - 4665 E Galbraith Rd

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Site Not Available

  • Palmetto Clinical Trial Services LLC

    Simpsonville, South Carolina 29615
    United States

    Site Not Available

  • Palmetto Clinical Trial Services LLC

    Simpsonville 4595864, South Carolina 4597040 29615
    United States

    Site Not Available

  • Stride Clinical Research LLC

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • Zenos Clinical Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Epic Clinical Research

    Lewisville 4706057, Texas 4736286 75057
    United States

    Site Not Available

  • Sienna Dermatology

    Sugar Land 4734825, Texas 4736286 77479
    United States

    Site Not Available

  • Center for Clinical Studies LTD.LLP

    Webster 4740423, Texas 4736286 77598
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Jordan Valley Dermatology Center - South Jordan

    South Jordan 5781770, Utah 5549030 84095
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.