A Study of Barzolvolimab in Patients With Atopic Dermatitis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT06727552

Run by

Celldex Therapeutics

People needed

131

Starts

2024-12-18

Expected to finish

2026-12-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 years of age
• Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
• Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:
• EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
• Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
• IGA score ≥ 3 at Visit 1 and Visit 2
• Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment
• Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
• Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.

You may not qualify if…

• Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
• Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
• Planned or anticipated use of any prohibited medications at any time during the study.
• 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.

Where it is running

• Cahaba Dermatology & Skin Health Center, LLC — Birmingham, Alabama, United States
• Ohara Aivaz MD Dermatology — Beverly Hills, California, United States
• Advanced Dermatology Center - Burbank — Burbank, California, United States
• 310 Clinical Research — Inglewood, California, United States
• Avance Trials — Laguna Niguel, California, United States
• LA Universal Research Center, Inc. — Los Angeles, California, United States
• UCLA Division of Dermatology — Los Angeles, California, United States
• Dynasty Dermatology — Pasadena, California, United States
• Acclaim Clinical Research — San Diego, California, United States
• FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group — Ventura, California, United States
• Focus Clinical Research — West Hills, California, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• International Dermatology Research Inc - Miami — Miami Lakes, Florida, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• Well Pharma Medical Research Corporation — South Miami, Florida, United States
• Centricity Research Columbus Dermatology — Columbus, Georgia, United States
• Georgia Skin and Cancer Clinic — Savannah, Georgia, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Center for Medical Dermatology + Immunology Research — Chicago, Illinois, United States
• Sneeze Wheeze and Itch Associates LLC — Normal, Illinois, United States
• Equity Medical LLC — Bowling Green, Kentucky, United States
• Allergy and Asthma Specialists PSC — Owensboro, Kentucky, United States
• Onyx Clinical Research - Michigan — Flint, Michigan, United States
• Revival Research Institute, LLC — Troy, Michigan, United States
• Excel Clinical Research — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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