A Study of Barzolvolimab in Patients With Atopic Dermatitis
Purpose
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
Condition
- Atopic Dermatitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Barzolvolimab 150 mg |
Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks |
|
|
Experimental Barzolvolimab 300 mg |
Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks |
|
|
Experimental 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. |
|
|
Experimental 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. |
|
Recruiting Locations
AllerVie Clinical Research
Birmingham 4049979, Alabama 4829764 35209
Birmingham 4049979, Alabama 4829764 35209
Cahaba Dermatology & Skin Health Center, LLC
Birmingham 4049979, Alabama 4829764 35244
Birmingham 4049979, Alabama 4829764 35244
Ohara Aivaz MD Dermatology
Beverly Hills 5328041, California 5332921 90212
Beverly Hills 5328041, California 5332921 90212
Advanced Dermatology Center - Burbank
Burbank 5331835, California 5332921 91506
Burbank 5331835, California 5332921 91506
310 Clinical Research
Inglewood 5359488, California 5332921 90301
Inglewood 5359488, California 5332921 90301
Avance Trials
Laguna Niguel 5364329, California 5332921 92677
Laguna Niguel 5364329, California 5332921 92677
LA Universal Research Center, Inc.
Los Angeles 5368361, California 5332921 90057
Los Angeles 5368361, California 5332921 90057
UCLA Division of Dermatology
Los Angeles 5368361, California 5332921 90089
Los Angeles 5368361, California 5332921 90089
Dynasty Dermatology
Pasadena 5381396, California 5332921 91105
Pasadena 5381396, California 5332921 91105
Acclaim Clinical Research
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
Clinical Science Institute
Santa Monica 5393212, California 5332921 90404
Santa Monica 5393212, California 5332921 90404
FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
Ventura 5405878, California 5332921 93003
Ventura 5405878, California 5332921 93003
Pacific Clinical Innovations Inc.
Vista 5406602, California 5332921 92083
Vista 5406602, California 5332921 92083
Focus Clinical Research
West Hills 8030162, California 5332921 91307
West Hills 8030162, California 5332921 91307
Direct Helpers Research Center
Hialeah 4158476, Florida 4155751 33012
Hialeah 4158476, Florida 4155751 33012
University of Miami
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
International Dermatology Research Inc - Miami
Miami Lakes 4164186, Florida 4155751 33144
Miami Lakes 4164186, Florida 4155751 33144
Sarasota Clinical Research
Sarasota 4172131, Florida 4155751 34233
Sarasota 4172131, Florida 4155751 34233
Well Pharma Medical Research Corporation
South Miami 4173495, Florida 4155751 33173
South Miami 4173495, Florida 4155751 33173
Centricity Research Columbus Dermatology
Columbus 4188985, Georgia 4197000 31904
Columbus 4188985, Georgia 4197000 31904
Georgia Skin and Cancer Clinic
Savannah 4221552, Georgia 4197000 31419
Savannah 4221552, Georgia 4197000 31419
Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706
Boise 5586437, Idaho 5596512 83706
Center for Medical Dermatology + Immunology Research
Chicago 4887398, Illinois 4896861 60657
Chicago 4887398, Illinois 4896861 60657
Sneeze Wheeze and Itch Associates LLC
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
Equity Medical LLC
Bowling Green 4285268, Kentucky 6254925 42104
Bowling Green 4285268, Kentucky 6254925 42104
Allergy and Asthma Specialists PSC
Owensboro 4303436, Kentucky 6254925 42301
Owensboro 4303436, Kentucky 6254925 42301
Onyx Clinical Research - Michigan
Flint 4992982, Michigan 5001836 48532
Flint 4992982, Michigan 5001836 48532
Derm Center
Troy 5012639, Michigan 5001836 48084
Troy 5012639, Michigan 5001836 48084
Revival Research Institute, LLC
Troy 5012639, Michigan 5001836 48084
Troy 5012639, Michigan 5001836 48084
Excel Clinical Research
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89109
Equity Medical, LLC
New York 5128581, New York 5128638 10023
New York 5128581, New York 5128638 10023
OptiSkin Medical
New York 5128581, New York 5128638 10128
New York 5128581, New York 5128638 10128
Bernstein Clinical Research Center, LLC
Cincinnati 4508722, Ohio 5165418 45236
Cincinnati 4508722, Ohio 5165418 45236
Palmetto Clinical Trial Services LLC
Simpsonville 4595864, South Carolina 4597040 29615
Simpsonville 4595864, South Carolina 4597040 29615
Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230
Dallas 4684888, Texas 4736286 75230
Epic Clinical Research
Lewisville 4706057, Texas 4736286 75057
Lewisville 4706057, Texas 4736286 75057
Sienna Dermatology
Sugar Land 4734825, Texas 4736286 77479
Sugar Land 4734825, Texas 4736286 77479
Center for Clinical Studies LTD.LLP
Webster 4740423, Texas 4736286 77598
Webster 4740423, Texas 4736286 77598
Jordan Valley Dermatology Center - South Jordan
South Jordan 5781770, Utah 5549030 84095
South Jordan 5781770, Utah 5549030 84095
More Details
- NCT ID
- NCT06727552
- Status
- Recruiting
- Sponsor
- Celldex Therapeutics
Detailed Description
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis. 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.