A Phase II Study in Patients With Alopecia Areata

Reistone Biopharma

Status and phase: Completed; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT04346316

RSJ10521

Details and patient eligibility

About

This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

Full description

The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between 18-65 years of age (both inclusive), at the time of informed consent;
• Must have moderate to severe alopecia areata.

Exclusion criteria

• Other types of alopecia or other diseases that can cause hair loss
• Other scalp diseases that could interfere with assessment of hair loss/regrowth
• Any previous use of any Janus kinase (JAK) inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 4 patient groups, including a placebo group

SHR0302 Dose#1

Active Comparator group

Treatment:

Drug: SHR0302

SHR0302 Dose#2

Active Comparator group

Treatment:

Drug: SHR0302

SHR0302 Dose#3

Active Comparator group

Treatment:

Drug: SHR0302

Placebo

Placebo Comparator group

Treatment:

Drug: SHR0302