A Randomized, Double-Blinded, and Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata

Reistone Biopharma Company Limited31 sites in 1 country330 target enrollmentApril 18, 2022

ConditionsAlopecia Areata

InterventionsSHR0302 Placebo

DrugsSHR0302 Placebo

Overview

Phase: Phase 3
Intervention: SHR0302
Conditions: Alopecia Areata
Sponsor: Reistone Biopharma Company Limited
Enrollment: 330
Locations: 31
Primary Endpoint: Percentage of subjects achieving a SALT score ≤ 20 at week 24
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 18, 2022

End Date

February 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Reistone Biopharma Company Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent
•Have severe alopecia areata (AA), as determined by all of the followings:
•Clinical diagnosis of AA with no other cause of hair loss;
•≥ 50% scalp involvement of alopecia (using SALT score), including alopecia totalis (AT) and alopecia universalis (AU). AT refers to scalp hair loss SALT 95-100 (both inclusive) and AU refers to scalp hair loss SALT 95-100 (both inclusive), plus facial or body hair loss.
•Duration of the current episode of scalp hair loss of at least 6 months and less than 8 years, and without terminal hair regrowth within 6 months prior to screening and baseline
•All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from the signing of informed consent, throughout the duration of the study, and for 4 weeks after the last dose of investigational drugs.
•Capable of providing a signed and dated informed consent form indicating the subject has been fully informed, and are willing to comply with the scheduled visits, treatment plan, laboratory testing, and other study procedures.

Exclusion Criteria

•Alopecia caused by other reasons, including but not limited to syphilitic alopecia, androgenetic alopecia (AGA), scarring alopecia, diffuse alopecia (manifested as diffuse hair loss), serpiginous alopecia areata (involving the temporal and occipital hairline), traction alopecia, anagen effluvium, folliculotropic mycosis fungoides (FMF), or hair loss caused by thyroid diseases.
•Any other active skin disease, scalp disorder, or active scalp trauma, that in the opinion of the investigator would interfere with study assessments of efficacy or safety. Subjects with shaved heads must not enter the study until the hair has grown back and is considered stable by the investigator.
•Have received any of the following treatment within the specified timeframes:
•Previously systemic treated with JAK inhibitors, e.g., tofacitinib, baricitinib, upadacitinib, PF04965842, and ritlecitinib (PF-06651600).
•Exception: Patients with previous use of topical JAK inhibitors for diseases other than AA (non-scalp sites) were allowed. (discontinued 8 weeks prior to the first dose).
•Any of the below treatments within 8 weeks prior to the first dose of investigational drugs: topical immunotherapy, e.g., diphenylcyclopropenone (DPCP); systemic treatment to AA, e.g., oral or intravenous corticosteroids, cyclosporin; and intralesional immunosuppressant therapy.
•Any of the below treatments within 4 weeks or 5 half-lives of the drug (if known) prior to the first dose of investigational drugs, whichever is longer: topical treatments, phototherapy, cryotherapy, or any other treatment to AA.
•Subjects have potential active, latent, or inadequately treated infection of tubercle bacillus (TB, including, but not limited to pulmonary TB), as evidenced by any of the followings:
•Subjects is currently being treated for active TB infection.
•Positive QuantiFERON-TB Gold (QFT Gold test) or T-SPOT test or other interferon-gamma release assays (IGRAs) test performed within 3 months prior to/within the screening period, and those who have negative results of above tests but with clinical symptoms and/or abnormal chest X-ray that could not exclude TB infection;

Arms & Interventions

SHR0302 4 mg

Drug：SHR0302

Intervention: SHR0302

SHR0302 8 mg

Drug：SHR0302

Intervention: SHR0302

Placebo

Drug: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of subjects achieving a SALT score ≤ 20 at week 24

Time Frame: 24 weeks

Percentage of subjects achieving a SALT score ≤ 20 at week 24

Secondary Outcomes

Percentage of subjects achieving a 50% improvement in SALT score (SALT50) at Week 24.(24 weeks)
Percentage of subjects with a SALT score ≤ 20 at Weeks 4, 8, 12, 16, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 28, 36, 44, and 52)
Percentage of subjects achieving a 50% improvement in SALT score (SALT50) at Weeks 4, 8, 12, 16, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 28, 36, 44, and 52.)
Absolute change from baseline in SALT score at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.)
Percentage of subjects with an absolute SALT score ≤ 10 at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.)
Percentage change from baseline in SALT score at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.)
Percentage of subjects achieving a 75% improvement in SALT score (SALT75) at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.)
Percentage of subjects achieving a 90% improvement in SALT score (SALT90) at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.(Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.)
Percentage of subjects achieving "Satisfied" in Subject's Global Assessment (SGA) at Weeks 24, 36, and 52.(Weeks 24, 36, and 52.)