Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Phase 3 Completed 336 enrolled Reistone Biopharma Company Limited

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.

Timeline

Start: 2021-04-30
Primary completion: 2022-08-12
Completion: 2023-05-23

Outcome

Met primary endpoint

paper significantly more patients in the 4-mg ivarmacitinib group (41 of 113 [36.3%]; 95% CI, 27.5%-45.9%; P < .001) PMID 40305055 ↗

paper EASI-75 responses were also significantly higher in the ivarmacitinib groups: 61 patients (54.0%; 95% CI, 44.4%-63.4%; P < .001) PMID 40305055 ↗

Publications

Zhao Y, Gooderham M, Yang B, Wu J, Wu L, Loo WJ, Toth D, Sauder M, Li J, Chen A, Tao X, Lu J, Song Z, Han J, Li H, Li Y, Xu L, Zhang J. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):688-697. doi: 10.1001/jamadermatol.2025.0982.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHR0302	Unknown	4 mg	Oral
Subject	SHR0302	Unknown	8 mg	Oral