Active — Not RecruitingPhase 2

A Study of Barzolvolimab in Patients With Atopic Dermatitis

United States131 participantsStarted 2024-12-18

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16

Timeframe: From Day 1 (first dose) to Day 113 (week 16)

NCT IDNCT06727552

SponsorCelldex Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.