Atopic Dermatitis
Conditions
Keywords
AD, Atopic Dermatitis, eczema, barzolvolimab, CDX-0159, CDX0159-15
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.
Interventions
BIOLOGICALBarzolvolimab
Subcutaneous Administration
DRUGMatching placebo
Subcutaneous Administration
Sponsors
Celldex Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16 | From Day 1 (first dose) to Day 113 (week 16) | Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16. | From Day 1 (first dose) to Day 113 (week 16) | A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD. * 0 = clear * 0.1-1.0 = almost clear * 1.1-7.0 = mild * 7.1-21.0 = moderate * 21.1-50.0 = severe * 50.1-72.0 = very severe |
| Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16. | From Day 1 (first dose) to Day 113 (week 16) | The IGA determines severity of AD and clinical response to treatment on a static 5-point scale based on erythema and papulation/infiltration * 0 = Clear * 1 = Almost clear * 2 = Mild * 3 = Moderate * 4 = Severe |
Countries
United States
Outcome results
None listed