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01
Overview
Phase 2, randomised, double-blind trial of CGB-500 in atopic dermatitis (AD) (3 arms), sponsored by CAGE Bio. Primary endpoints: Safety and tolerability at 8 weeks and Effectiveness at 8 weeks. Started Dec 2024; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
CGB-500 0.5%
CGB-500 Topical Ointment with 0.5% Tofacitinib BID
CGB-500 1%
CGB-500 Topical Ointment with 1% Tofacitinib BID
Vehicle
Vehicle for CGB-500 Topical Ointment BID
03
Who it enrols
Patients aged 12 and older with a clinical diagnosis of atopic dermatitis for at least 12 months, stable for >= 3 months, with an IGA score of 2-4, BSA 1% to <10%, and PPNRS >= 4. Excludes pregnant/breastfeeding women, immunocompromised individuals, and those with recent use of prohibited medications (e.g., JAK inhibitors, biologics, systemic corticosteroids).
04
Endpoints
Primary
Safety and tolerability
Effectiveness
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