A Study of Barzolvolimab in Patients With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Matching placebo
- Registration Number
- NCT06727552
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Barzolvolimab 150 mg Barzolvolimab Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks Barzolvolimab 300 mg Barzolvolimab Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks Placebo then barzolvolimab 150 mg Barzolvolimab 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. Placebo then barzolvolimab 150 mg Matching placebo 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. Placebo then barzolvolimab 300 mg Barzolvolimab 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. Placebo then barzolvolimab 300 mg Matching placebo 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.
- Primary Outcome Measures
Name Time Method Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16 From Day 1 (first dose) to Day 113 (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.
- Secondary Outcome Measures
Name Time Method Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16. From Day 1 (first dose) to Day 113 (week 16) A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD.
* 0 = clear
* 0.1-1.0 = almost clear
* 1.1-7.0 = mild
* 7.1-21.0 = moderate
* 21.1-50.0 = severe
* 50.1-72.0 = very severeProportion 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) The IGA determines severity of AD and clinical response to treatment on a static 5-point scale based on erythema and papulation/infiltration
* 0 = Clear
* 1 = Almost clear
* 2 = Mild
* 3 = Moderate
* 4 = Severe
Related Research Topics
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Trial Locations
- Locations (24)
Ohara Aivaz MD Dermatology
🇺🇸Beverly Hills, California, United States
Georgia Skin and Cancer Clinic
🇺🇸Savannah, Georgia, United States
Avance Trials
🇺🇸Laguna Niguel, California, United States
Dynasty Dermatology
🇺🇸Pasadena, California, United States
Well Pharma Medical Research Corporation
🇺🇸South Miami, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Revival Research Institute, LLC
🇺🇸Troy, Michigan, United States
Lane Dermatology Research - Centricity - PPDS
🇺🇸Columbus, Georgia, United States
Center for Medical Dermatology and Immunology Research
🇺🇸Chicago, Illinois, United States
Onyx Clinical Research - Michigan
🇺🇸Flint, Michigan, United States
Stride Clinical Research LLC
🇺🇸Sugar Land, Texas, United States
Cahaba Dermatology & Skin Health Center
🇺🇸Birmingham, Alabama, United States
FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
🇺🇸Ventura, California, United States
International Dermatology Research Inc - Miami
🇺🇸Miami Lakes, Florida, United States
Bernstein Clinical Research Center, LLC - 4665 E Galbraith Rd
🇺🇸Cincinnati, Ohio, United States
Advanced Dermatology Center
🇺🇸Burbank, California, United States
LA Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
Windom Allergy, Asthma & Sinus
🇺🇸Sarasota, Florida, United States
Atlanta Biomedical Clinical Research
🇺🇸Atlanta, Georgia, United States
Allergy and Asthma Specialists PSC
🇺🇸Owensboro, Kentucky, United States
OptiSkin Medical
🇺🇸New York, New York, United States
Palmetto Clinical Trial Services LLC
🇺🇸Simpsonville, South Carolina, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Jordan Valley Dermatology Center
🇺🇸South Jordan, Utah, United States