A Study of Barzolvolimab in Patients With Atopic Dermatitis
NCT ID: NCT06727552
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-01-07
2027-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Barzolvolimab 150 mg
Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks
Barzolvolimab
Subcutaneous Administration
Barzolvolimab 300 mg
Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks
Barzolvolimab
Subcutaneous Administration
Placebo then barzolvolimab 150 mg
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.
Barzolvolimab
Subcutaneous Administration
Matching placebo
Subcutaneous Administration
Placebo then barzolvolimab 300 mg
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.
Barzolvolimab
Subcutaneous Administration
Matching placebo
Subcutaneous Administration
Interventions
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Barzolvolimab
Subcutaneous Administration
Matching placebo
Subcutaneous Administration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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AllerVie Clinical Research
Birmingham, Alabama, United States
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
Clinical Science Institute
Santa Monica, California, United States
FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
Ventura, California, United States
Pacific Clinical Innovations Inc.
Vista, California, United States
Focus Clinical Research
West Hills, California, United States
Direct Helpers Research Center
Hialeah, Florida, United States
University of Miami
Miami, 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
Derm Center
Troy, Michigan, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Equity Medical, LLC
New York, New York, United States
OptiSkin Medical
New York, New York, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Palmetto Clinical Trial Services LLC
Simpsonville, South Carolina, United States
Zenos Clinical Research
Dallas, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
Sienna Dermatology
Sugar Land, Texas, United States
Center for Clinical Studies LTD.LLP
Webster, Texas, United States
Jordan Valley Dermatology Center - South Jordan
South Jordan, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDX0159-15
Identifier Type: -
Identifier Source: org_study_id
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