NCT05470413 is a Phase 3 clinical trial of SHR0302 in Alopecia Areata, sponsored by Reistone Biopharma Company Limited.

Who is sponsoring NCT05470413?

NCT05470413 is sponsored by Reistone Biopharma Company Limited.

What drugs are being tested in NCT05470413?

Interventions in NCT05470413: SHR0302, SHR0302, Placebo.

What condition does NCT05470413 study?

NCT05470413 studies Alopecia Areata.

Is NCT05470413 still recruiting?

NCT05470413 is currently status unknown. Last updated 5 September 2023.

Last reviewed 2023-09-05 · How we verify

NCT05470413

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata

Status unknown Phase 3 Last updated 5 September 2023

What this trial tests

Phase 3 trial testing SHR0302 in Alopecia Areata in 330 participants. Status unknown.

Timeline

18 April 2022

Primary endpoint
31 October 2023

15 February 2024

Quick facts

Lead sponsor	Reistone Biopharma Company Limited
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	330
Start date	18 April 2022
Primary completion	31 October 2023
Estimated completion	15 February 2024
Sites	31 locations across China

Drugs / interventions tested

SHR0302 — full drug profile →
SHR0302 — full drug profile →
Placebo

Conditions studied

Alopecia Areata — all drugs for Alopecia Areata →

Sponsor

Reistone Biopharma Company Limited — full company profile →

Who can join

Adults 18 to 65, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-central, double-blind, randomized, parallel, placebo-controlled phase 3 study in adult subjects with severe alopecia areata (SALT≥50%). Approximately 330 adult patients will be enrolled into the study. Efficacy and safety of two doses of SHR0302 will be compared to placebo.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Alopecia Areata: Pathogenesis, Diagnosis, and Therapies.
Ma T, Zhang T, Miao F, Liu J, et al · · 2025 · cited 13× · PMID 40260013 · DOI 10.1002/mco2.70182
Hair regrowth in alopecia areata and re-pigmentation in vitiligo in response to treatment: Commonalities and differences.
Yamaguchi HL, Yamaguchi Y, Peeva E. · · 2025 · cited 9× · PMID 39258892 · DOI 10.1111/jdv.20311
From mechanisms to therapies: current advances breakthroughs in alopecia areata immunopathology.
Zhao HB, Zhang YN, Qiang Y, Wang GM, et al · · 2025 · cited 2× · PMID 40959061 · DOI 10.3389/fimmu.2025.1621492
Alopecia areata: from immunopathogenesis to emerging therapeutic approaches.
Kim SY, Lee HJ, Heo J, Kim BJ, et al · · 2025 · PMID 41280915 · DOI 10.3389/fimmu.2025.1681163

Verify or expand the search:

Other trials of SHR0302

Trials testing the same drug.

NCT05900089 — Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma · Phase 1 · not yet recruiting
NCT05856058 — To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability · Phase 1 · completed
NCT05324631 — A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis · Phase 3 · unknown
NCT05181137 — A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis · Phase 3 · unknown
NCT04712838 — Study on the Bioavailability of SHR0302 in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Alopecia Areata

Currently open trials in the same condition.

NCT07242638 — Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome · Phase 2 · recruiting
NCT07311564 — A Study of LAD603 in Adults With Alopecia Areata · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
NCT07205159 — A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. · Phase 1 · recruiting
NCT06747611 — Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata · Phase 2 · recruiting

Other Reistone Biopharma Company Limited trials

Trials by the same sponsor.

NCT05136456 — Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy · Phase 2 · unknown
NCT05181137 — A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis · Phase 3 · unknown
NCT04875169 — Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatit · Phase 3 · completed
NCT04670770 — An Open Label Study of the Effects of SHR1459 in NMOSDs Patients · Phase 2 · completed
NCT04717310 — Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis · Phase 2, PHASE3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05470413 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Reistone Biopharma Company Limited
Last refreshed: 5 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05470413.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing