A Study of Barzolvolimab in Patients With Atopic Dermatitis

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Beverly Hills 5328041, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by April W. Armstrong, MD, MPH
Headshot of April W. Armstrong
April W. Armstrong

Description

Summary

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

Official Title

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

Details

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.

Keywords

Atopic Dermatitis, AD, eczema, barzolvolimab, CDX-0159, CDX0159-15, Barzolvolimab 150 mg, Barzolvolimab 300 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • Ohara Aivaz MD Dermatology accepting new patients
    Beverly Hills 5328041 California 5332921 90212 United States
  • Advanced Dermatology Center accepting new patients
    Burbank 5331835 California 5332921 91506 United States
  • LA Universal Research Center, Inc. accepting new patients
    Los Angeles 5368361 California 5332921 90057 United States
  • Dynasty Dermatology accepting new patients
    Pasadena 5381396 California 5332921 91105 United States

Lead Scientist at UCLA

  • April W. Armstrong, MD, MPH
    Dr. April Armstrong is Professor and Chief of Dermatology at University of California Los Angeles (UCLA). She oversees and leads the dermatology division, including managing clinical operations and promoting research and education. She also serves as Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celldex Therapeutics
Links
Sign up for this study
ID
NCT06727552
Phase
Phase 2 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated
Contact us about this trial