A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Adult Patients With Moderate and Severe Atopic Dermatitis

NCT05526222 Phase 3 ACTIVE_NOT_RECRUITING

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis

Details

Lead sponsor	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	443
Start date	2022-07-14
Completion	2026-09

Conditions

• Atopic Dermatitis

Interventions

• Jaktinib Hydrochloride Tablet

Primary outcomes

• The efficacy in the treatment of moderate and severe atopic dermatitis — 16 weeks
  The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline
• The efficacy in the treatment of moderate and severe atopic dermatitis — 16 weeks
  The proportion of subjects with a systemic Investigator's Global Assessment (IGA) score of 0 or 1 and a decrease of ≥ 2 points from baseline

Countries

China