Clinical trial NCT06727552: A Study of Barzolvolimab in Patients 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: AD
Atopic Dermatitis
eczema
barzolvolimab
CDX-0159
CDX0159-15
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
timeFrame: From Day 1 (first dose) to Day 113 (week 16)
Secondary outcomes:
measure: Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16.
timeFrame: From Day 1 (first dose) to Day 113 (week 16)
measure: Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16.
timeFrame: From Day 1 (first dose) to Day 113 (week 16)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center
state: Alabama
city: Beverly Hills
country: United States
facility: Ohara Aivaz MD Dermatology
state: California
city: Burbank
country: United States
facility: Advanced Dermatology Center
state: California
city: Laguna Niguel
country: United States
facility: Avance Trials
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, Inc.
state: California
city: Pasadena
country: United States
facility: Dynasty Dermatology
state: California
city: Ventura
country: United States
facility: FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
state: California
city: Miami Lakes
country: United States
facility: International Dermatology Research Inc - Miami
state: Florida
city: Sarasota
country: United States
facility: Windom Allergy, Asthma & Sinus
state: Florida
city: South Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Atlanta
country: United States
facility: Atlanta Biomedical Clinical Research
state: Georgia
city: Columbus
country: United States
facility: Lane Dermatology Research - Centricity - PPDS
state: Georgia
city: Savannah
country: United States
facility: Georgia Skin and Cancer Clinic
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Center for Medical Dermatology and Immunology Research
state: Illinois
city: Owensboro
country: United States
facility: Allergy and Asthma Specialists PSC
state: Kentucky
city: Flint
country: United States
facility: Onyx Clinical Research - Michigan
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC - 4665 E Galbraith Rd
state: Ohio
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services LLC
state: South Carolina
city: Sugar Land
country: United States
facility: Stride Clinical Research LLC
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
Study officials:
References: