A Study of Barzolvolimab in Patients With Atopic Dermatitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: Barzolvolimab; Drug: Matching placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology & Skin Health Center, LLC
  • California
    • Beverly Hills, California, United States, 90212
      • Ohara Aivaz MD Dermatology
    • Burbank, California, United States, 91506
      • Advanced Dermatology Center - Burbank
    • Inglewood, California, United States, 90301
      • 310 Clinical Research
    • Laguna Niguel, California, United States, 92677
      • Avance Trials
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center, Inc.
    • Los Angeles, California, United States, 90089
      • UCLA Division of Dermatology
    • Pasadena, California, United States, 91105
      • Dynasty Dermatology
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • Ventura, California, United States, 93003
      • FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
    • West Hills, California, United States, 91307
      • Focus Clinical Research
  • Florida
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Miami Lakes, Florida, United States, 33144
      • International Dermatology Research Inc - Miami
    • Sarasota, Florida, United States, 34233
      • Sarasota Clinical Research
    • South Miami, Florida, United States, 33173
      • Well Pharma Medical Research Corporation
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Centricity Research Columbus Dermatology
    • Savannah, Georgia, United States, 31419
      • Georgia Skin and Cancer Clinic
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Center for Medical Dermatology + Immunology Research
    • Normal, Illinois, United States, 61761
      • Sneeze Wheeze and Itch Associates LLC
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical LLC
    • Owensboro, Kentucky, United States, 42301
      • Allergy and Asthma Specialists PSC
  • Michigan
    • Flint, Michigan, United States, 48532
      • Onyx Clinical Research - Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
  • New York
    • New York, New York, United States, 10128
      • OptiSkin Medical
    • New York, New York, United States, 10023
      • Equity Medical, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC
  • South Carolina
    • Simpsonville, South Carolina, United States, 29615
      • Palmetto Clinical Trial Services LLC
  • Texas
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Sienna Dermatology
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies LTD.LLP
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center - South Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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:

1. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barzolvolimab 150 mg; Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks	Biological: Barzolvolimab; Subcutaneous Administration
Experimental: Barzolvolimab 300 mg; Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks	Biological: Barzolvolimab; Subcutaneous Administration
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.	Biological: Barzolvolimab; Subcutaneous Administration; Drug: Matching placebo; Subcutaneous Administration
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.	Biological: Barzolvolimab; Subcutaneous Administration; Drug: Matching placebo; Subcutaneous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from Baseline in Eczema Area Severity Index (EASI) score at 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 severe	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.	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	From Day 1 (first dose) to Day 113 (week 16)

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: eczema; Atopic Dermatitis; AD; CDX-0159; barzolvolimab; CDX0159-15
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema
• Other Study ID Numbers: CDX0159-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No