A Phase 2 Study of CDX-0159 in Patients With Atopic Dermatitis

Description

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

Conditions

Atopic Dermatitis

Study Overview

Study Details

Study overview

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

A Phase 2 Study of CDX-0159 in Patients With Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Troy

Revival Research Institute, LLC, Troy, Michigan, United States, 48084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celldex Therapeutics,

Study Record Dates

2027-05