RECRUITING

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

Conditions

Atopic Dermatitis AD eczema barzolvolimab CDX-0159 CDX0159-15

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-12

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06727552

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Celldex Therapeutics

CONTACT

844-723-9363

clinicaltrials@celldex.com

Study Locations (Sites)

Revival Research Institute, LLC

Troy, Michigan, 48084

United States

Collaborators and Investigators

Sponsor: Celldex Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-12

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

AD
Atopic Dermatitis
eczema
barzolvolimab
CDX-0159
CDX0159-15

Additional Relevant MeSH Terms

Atopic Dermatitis