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Clinical Trials in the USA / NCT06727552
Active, not recruiting Phase 2

A Study of Barzolvolimab in Patients With Atopic Dermatitis

NCT06727552 · tracked via the Priya Life Science USA tracker
Sponsor
Celldex Therapeutics
Phase
Phase 2
Started
2024-12-18
Last updated
2026-08-11

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Barzolvolimab →Matching placebo

Barzolvolimab: Subcutaneous Administration

Matching placebo: Subcutaneous Administration

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
Cahaba Dermatology & Skin Health Center, LLC Birmingham Alabama
Ohara Aivaz MD Dermatology Beverly Hills California
Advanced Dermatology Center - Burbank Burbank California
310 Clinical Research Inglewood California
Avance Trials Laguna Niguel California
LA Universal Research Center, Inc. Los Angeles California
UCLA Division of Dermatology Los Angeles California
Dynasty Dermatology Pasadena California
Acclaim Clinical Research San Diego California
FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group Ventura California
Focus Clinical Research West Hills California
Direct Helpers Research Center Hialeah Florida
International Dermatology Research Inc - Miami Miami Lakes Florida
Sarasota Clinical Research Sarasota Florida
Well Pharma Medical Research Corporation South Miami Florida
Centricity Research Columbus Dermatology Columbus Georgia
Georgia Skin and Cancer Clinic Savannah Georgia
Treasure Valley Medical Research Boise Idaho
Center for Medical Dermatology + Immunology Research Chicago Illinois
Sneeze Wheeze and Itch Associates LLC Normal Illinois
Equity Medical LLC Bowling Green Kentucky
Allergy and Asthma Specialists PSC Owensboro Kentucky
Onyx Clinical Research - Michigan Flint Michigan
Revival Research Institute, LLC Troy Michigan
Excel Clinical Research Las Vegas Nevada
Equity Medical, LLC New York New York
OptiSkin Medical New York New York
Bernstein Clinical Research Center, LLC Cincinnati Ohio
Palmetto Clinical Trial Services LLC Simpsonville South Carolina
Zenos Clinical Research Dallas Texas
Sienna Dermatology Sugar Land Texas
Center for Clinical Studies LTD.LLP Webster Texas
Jordan Valley Dermatology Center - South Jordan South Jordan Utah

More Celldex Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06727552 on ClinicalTrials.gov ↗ ← All trials in the USA