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Evaluating barzolvolimab for treating atopic dermatitis in adults

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

Phase 2 Interventional Celldex Therapeutics · NCT06727552

This study is testing if a new treatment called barzolvolimab can help adults with chronic atopic dermatitis feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorCelldex Therapeutics Industry-sponsored
Drugs / interventionsbarzolvolimab
Locations24 sites (Birmingham, Alabama and 23 other locations)
Trial IDNCT06727552 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial investigates the efficacy and safety of barzolvolimab (CDX-0159) in adults diagnosed with chronic atopic dermatitis. The study is designed as a multicenter, randomized, double-blind, placebo-controlled trial, involving a screening period followed by a 16-week treatment phase. Participants will receive either barzolvolimab or a placebo through subcutaneous injections, with a follow-up period of 16 weeks to assess outcomes. The trial aims to determine the effectiveness of different dosing regimens of barzolvolimab in alleviating symptoms of atopic dermatitis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic atopic dermatitis and a history of inadequate response to topical treatments.

Not a fit: Patients with other active pruritic skin diseases or those who have not had a prior inadequate response to topical medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate to severe atopic dermatitis.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for atopic dermatitis, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisADeczemabarzolvolimabCDX-0159CDX0159-15
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.