A Study of Barzolvolimab in Patients With Atopic Dermatitis

NCT06727552 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CDX0159-15
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 33

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

AD; Atopic Dermatitis; eczema; barzolvolimab; CDX-0159; CDX0159-15

Outcome Measures

Primary Outcomes (1)

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

  Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period.

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

Secondary Outcomes (2)

• Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16.

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

• Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16.

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

Study Arms (4)

Barzolvolimab 150 mg

EXPERIMENTAL

Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks

Biological: Barzolvolimab

Barzolvolimab 300 mg

EXPERIMENTAL

Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks

Biological: Barzolvolimab

Placebo then barzolvolimab 150 mg

EXPERIMENTAL

Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks.

Biological: Barzolvolimab; Drug: Matching placebo

Placebo then barzolvolimab 300 mg

EXPERIMENTAL

Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks.

Biological: Barzolvolimab; Drug: Matching placebo

Interventions

Barzolvolimab BIOLOGICAL

Subcutaneous Administration

Barzolvolimab 150 mg; Barzolvolimab 300 mg; Placebo then barzolvolimab 150 mg; Placebo then barzolvolimab 300 mg

Matching placebo DRUG

Subcutaneous Administration

Placebo then barzolvolimab 150 mg; Placebo then barzolvolimab 300 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (33)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, 35244, United States

Location

Ohara Aivaz MD Dermatology

Beverly Hills, California, 90212, United States

Location

Advanced Dermatology Center - Burbank

Burbank, California, 91506, United States

Location

310 Clinical Research

Inglewood, California, 90301, United States

Location

Avance Trials

Laguna Niguel, California, 92677, United States

Location

LA Universal Research Center, Inc.

Los Angeles, California, 90057, United States

Location

UCLA Division of Dermatology

Los Angeles, California, 90089, United States

Location

Dynasty Dermatology

Pasadena, California, 91105, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

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

Ventura, California, 93003, United States

Location

Focus Clinical Research

West Hills, California, 91307, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

International Dermatology Research Inc - Miami

Miami Lakes, Florida, 33144, United States

Location

Sarasota Clinical Research

Sarasota, Florida, 34233, United States

Location

Well Pharma Medical Research Corporation

South Miami, Florida, 33173, United States

Location

Centricity Research Columbus Dermatology

Columbus, Georgia, 31904, United States

Location

Georgia Skin and Cancer Clinic

Savannah, Georgia, 31419, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Center for Medical Dermatology + Immunology Research

Chicago, Illinois, 60657, United States

Location

Sneeze Wheeze and Itch Associates LLC

Normal, Illinois, 61761, United States

Location

Equity Medical LLC

Bowling Green, Kentucky, 42104, United States

Location

Allergy and Asthma Specialists PSC

Owensboro, Kentucky, 42301, United States

Location

Onyx Clinical Research - Michigan

Flint, Michigan, 48532, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Equity Medical, LLC

New York, New York, 10023, United States

Location

OptiSkin Medical

New York, New York, 10128, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

Palmetto Clinical Trial Services LLC

Simpsonville, South Carolina, 29615, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Sienna Dermatology

Sugar Land, Texas, 77479, United States

Location

Center for Clinical Studies LTD.LLP

Webster, Texas, 77598, United States

Location

Jordan Valley Dermatology Center - South Jordan

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 11, 2024
• Study Start: December 18, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

US (33)