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

NCT05470413 | Unknown Phase 3 DMC

• 1 other identifier: RSJ10535
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 31

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

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

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

  24 weeks

Secondary Outcomes (9)

• 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.

• 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.

Study Arms (3)

SHR0302 4 mg

ACTIVE COMPARATOR

Drug：SHR0302

Drug: SHR0302

SHR0302 8 mg

ACTIVE COMPARATOR

Drug：SHR0302

Drug: SHR0302

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

SHR0302 DRUG

SHR0302 4 mg

SHR0302 4 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of either untreated or inadequately treated latent or active TB infection.
• Exception: Subject with a history of active TB who has documented evidence of appropriate treatment, has no history of re-exposure since his/her treatment was completed, and has a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria are met. Such subject would not be required to undergo the protocolspecific TB testing for QuantiFERON®-TB Gold test, or T-SPOT.TB test or other interferon-gamma release assays (IGRAs) test but must have a chest x-ray at screening.
• Subjects who currently have thyroid disorders (abnormal TSH levels at screening with associated abnormal fT4 or fT3 values, including hyperthyroidism and hypothyroidism), in the opinion of the investigator, pose an unacceptable risk for the patient's participation in the study.
• Note: Patients who are receiving thyroxine as replacement therapy may participate in the study, provided stable therapy has been administered for
• ≥12 weeks and TSH is within the laboratory's reference range. Patients who are receiving stable thyroxine replacement therapy who have TSH marginally outside the laboratory's normal reference range may participate if the treating physician has documented that the thyroxine replacement therapy is adequate for the patient.

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (31)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Wuhan No.1 Hospital

Wuhan, Hubei, China

Location

The second xiangya hospital of central south university

Changsha, Hunan, China

Location

Xiangya Hospital Of Central South University

Changsha, Hunan, China

Location

Dermatology Hospital of Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

Location

Jiangsu Province People's Hospital

Nanjing, Jiangsu, China

Location

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China

Location

Jiangxi Provincial Hospital of Dermatology

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Shengjing Hospital Of China Medical University

Shengyang, Liaoning, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Location

First Hospital Of Shanxi Medical University

Taiyuan, Shanxi, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital Of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: April 18, 2022
• Primary Completion: October 31, 2023
• Study Completion: February 15, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

CN (31)