A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
Male/female participants who are ≥2 years of age on the day of providing documented informed consent/assent.
Have a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (1980) at the Screening visit and a history of AD for at least 6 months (3 months for children under the age of 6).
Mild to moderate AD indicated by vIGA (Validated Investigator's Global Assessment) score of 2 (mild) or 3 (moderate) at Screening and at Day 1 prior to application of study intervention.
Have AD on the head (including face, but excluding hair-bearing scalp), neck, trunk (excluding groin and genitals), or limbs, covering at least ≥2% of total BSA (body surface area) and not more than 20% at Screening and at Day 1 (Visit 1).
Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
The presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
Other types of atopic dermatitis.
Parallel
zabalafin
DrugActive IP
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA.
Proportion of participants who achieve Validated Investigator's Global Assessment (vIGA) "clear or almost clear" with a 2-grade improvement from baseline at Day 113.
To evaluate the safety and tolerability of zabalafin hydrogel versus vehicle.
* Frequency and severity of Adverse Events (AEs) * Study intervention discontinuation due to AEs.
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by absolute change in Eczema area and severity index (EASI) score.
Absolute change in EASI score at Days 15, 29, 57, 85, and 113.
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA, where response is defined as achieving at least a 1-point decrease from baseline in vIGA score.
Proportion of participants achieving at least a 1-point decrease in vIGA score at Days 15, 29, 57, 85, and 113
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by peak pruritus numerical rating score (NRS), where response is defined as achieving at least a 4-point decrease from baseline.
Proportion of participants achieving at least a ≥4-point decrease in peak pruritus NRS at Days 15, 29, 57, 85, and 113.
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