This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.
This study contains two parts: Parts 1 and Part 2. Part 1 (Blinded Period): Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo. Part 2 (Extension Period): In part 2, all participants will receive camoteskimab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Drug Product
Inactive substance
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema. The EASI utilizes area assessments that rate the four involved regions on a 0% to 100% scale for each region. The scores are added up for each of the four body regions (head, arms, trunk, and legs). For each of these components, the individual scores are added together to calculate the EASI score, which ranges from 0 to 72. The higher the EASI score, the more severe the AD.
Time frame: 12 weeks
Percent change from baseline in EASI score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Time frame: 12 Weeks
Change from baseline in EASI score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Time frame: 12 weeks
Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Time frame: 12 weeks
Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12
To further assess the efficacy of camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity.
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Medical Dermatology Specialists, PC/US Dermatology Partners
Phoenix, Arizona, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology Research, Inc.
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
University of California Los Angeles Dermatology
Los Angeles, California, United States
Amicis Research Center (Northridge)
Northridge, California, United States
Cura Clinical Research
Oxnard, California, United States
VASDHS - Veterans Affairs San Diego Medical Center
San Diego, California, United States
Clinical Sciences Institute
Santa Monica, California, United States
...and 25 more locations
Time frame: 12 weeks
Change from baseline in peak pruritus score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Time frame: 12 weeks
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Time frame: 12 weeks
Change from baseline in POEM score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.
Time frame: 12 weeks
Change from baseline in DLQI score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life.
Time frame: 12 weeks
Change from baseline in AD involvement by BSA at Week 12
To further assess the efficacy of camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD.
Time frame: 12 weeks
Change from baseline in SP-NRS at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain.
Time frame: 12 weeks
Change from baseline in PROMIS-SRI-SF-8a score at Week 12 reported outcomes
To further assess the efficacy of camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being.
Time frame: 12 weeks