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 Genders
- 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
Birmingham, Alabama 35244
Beverly Hills, California 90212
Burbank, California 91506
Los Angeles, California 90057
Ventura, California 93003
Miami Lakes, Florida 33144
Sarasota, Florida 34233
South Miami, Florida 33173
Atlanta, Georgia 30331
Columbus, Georgia 31904
Savannah, Georgia 31419
Boise, Idaho 83706
Chicago, Illinois 60657
Owensboro, Kentucky 42301
Flint, Michigan 48532
Cincinnati, Ohio 45236
Simpsonville, South Carolina 29615
More Details
- 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.