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Alopecia AreataPhase 3NCT05470413

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

A Phase 3 study testing SHR0302 in people with Alopecia Areata, run by Reistone Biopharma Company Limited at 31 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alopecia Areata
What is being tested?
SHR0302
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
31 sitesChina
Study dates
18 Apr 2022to 15 Feb 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects with a history of thrombotic disease.
  • Subjects who may receive immunization with any live or attenuated vaccine within 4 weeks before the first dose of investigational drugs.
  • Subjects who have participated in clinical trials of any drug or medical device within the last 1 month or 5 half-lives of the drug (whichever is longer) before screening
  • Subjects with a history of severe neuropsychiatric disorders.
  • Subjects with evidence of clinical laboratory abnormalities at screening that, in the opinion of the investigator, may affect the safety of subjects or the interpretation of study results:
  • Hemoglobin level < 9.0 g/dL or hematocrit < 30%.
  • Absolute white blood cell (WBC) count < 3.0 × 109/L (< 3000/mm3) or absolute neutrophil count (ANC) < 1.2 × 109/L (< 1200/mm3).
  • Thrombocytopenia, as defined by a platelet count of < 100 × 109/L (< 100,000/mm3).
  • Total bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 2 × ULN. subjects with hepatic cirrhosis will be excluded.
  • Subjects with eGFR ≤ 60 mL/min based on Cockcroft-Gault calculation, or patients currently undergoing regular hemodialysis or peritoneal dialysis.
  • Screening 12-lead ECG that demonstrates clinically relevant abnormalities which, in the opinion of the investigator, may affect subject safety or would interfere with study assessments if being enrolled into the study.
  • Subject with the following concurrent or previous conditions:
  • Clinically significant infections (e.g., requiring hospitalization or parenteral antibiotics) or opportunistic infections within 1 month prior to baseline,
  • History of more than one episode of herpes zoster or disseminated herpes zoster (single episode) infection,
  • Any other infections that, in the opinion of the investigator, may aggravate if the subject participate in the study,
  • Any infection requiring antibacterial treatments within 2 weeks of randomized.
  • Women who are pregnant or lactating or planning pregnancy while enrolled in the study. Male subjects who are planning to donate sperm during the study or within 4 weeks after the last dose of investigational drugs.
  • History of alcohol or drug abuse with less than 6 months of abstinence prior to baseline, and unsuitable for the study in the opinion of the investigator.
  • Subjects with a history of hypersensitivity or allergies to JAKi, any of its ingredients, or similar compounds.
  • Subjects with malignancies/lymphadenosis or a history of malignancies/lymphadenosis, except for adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin.
  • Subjects with positive specific treponema pallidum antibody, human immunodeficiency virus (HIV), or hepatitis B/C virus:
  • HBV positive: HBsAg positive or HBcAb positive + HBV DNA positive. NOTE: Subjects with HBcAb positive + HBV DNA negative can participate in the study.
  • HCV positive: HCV antibody positive + HCV RNA positive. NOTE: Subjects with HCV antibody positive+ HCV RNA negative can participate in the study.
  • HIV positive: HIV antibody positive.
  • Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study.
  • With evidence of clinically significant cardiovascular, mental, renal, hepatic, immune, gastrointestinal, urogenital, nervous system, musculoskeletal, cutaneous, sensory, endocrine (including uncontrolled diabetes or thyroid disease), or hematologic abnormalities. A clinically significant disease is defined as any disease that in the opinion of the investigator will endanger the safety of a subject during the participation, or the disease/condition may worsen during the study and affect the efficacy or safety analysis.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The second xiangya hospital of central south university

    Changsha, Hunan

  • Xiangya Hospital Of Central South University

    Changsha, Hunan

  • West China Hospital Sichuan University

    Chengdu, Sichuan

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guanzhou, Guangdong

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang

  • The First Affiliated Hospital Of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Jiangxi Provincial Hospital of Dermatology

    Nanchang, Jiangxi

  • Dermatology Hospital of Chinese Academy of Medical Sciences

    Nanjing, Jiangsu

  • Jiangsu Province People's Hospital

    Nanjing, Jiangsu

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality

  • Shengjing Hospital Of China Medical University

    Shengyang, Liaoning

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • First Hospital Of Shanxi Medical University

    Taiyuan, Shanxi

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuhan No.1 Hospital

    Wuhan, Hubei

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

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
Being tested
SHR0302, Placebo
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR0302Drug

    SHR0302 4 mg

  • SHR0302Drug

    SHR0302 8 mg

  • PlaceboDrug

    Placebo

Study groups in NCT05470413
Study groupRoleWhat they receive
SHR0302 4 mgActive comparatorDrug：SHR0302
Receives: Drug: SHR0302
SHR0302 8 mgActive comparatorDrug：SHR0302
Receives: Drug: SHR0302
PlaceboPlacebo comparatorDrug: Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 weeks

Secondary outcomes (9)

  1. Percentage of subjects achieving a 50% improvement in SALT score (SALT50) at Week 24.

    Percentage of subjects achieving a 50% improvement in SALT score (SALT50) at Week 24.

    Measured: 24 weeks

  2. Percentage of subjects with a SALT score ≤ 20 at Weeks 4, 8, 12, 16, 28, 36, 44, and 52.

    Percentage of subjects with a SALT score ≤ 20 at Weeks 4, 8, 12, 16, 28, 36, 44, and 52.

    Measured: Weeks 4, 8, 12, 16, 28, 36, 44, and 52

  3. Percentage of subjects achieving a 50% improvement in SALT score (SALT50) at 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.

    Measured: Weeks 4, 8, 12, 16, 28, 36, 44, and 52.

  4. Percentage of subjects achieving a 75% improvement in SALT score (SALT75) at 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.

    Measured: Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

  5. Percentage of subjects achieving a 90% improvement in SALT score (SALT90) at 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.

    Measured: Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

  6. Absolute change from baseline in SALT score at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

    Absolute change from baseline in SALT score at Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

    Measured: Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

  7. Percentage change from baseline in SALT score at 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.

    Measured: Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

  8. Percentage of subjects with an absolute SALT score ≤ 10 at 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.

    Measured: Weeks 4, 8, 12, 16, 24, 28, 36, 44, and 52.

  9. Percentage of subjects achieving "Satisfied" in Subject's Global Assessment (SGA) at Weeks 24, 36, and 52.

    Percentage of subjects achieving "Satisfied" in Subject's Global Assessment (SGA) at Weeks 24, 36, and 52.

    Measured: Weeks 24, 36, and 52.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study start18 Apr 2022
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion15 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05470413
Sponsor's protocol ID
RSJ10535
Status last verified
Sep 2023
First submitted
20 Jul 2022
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou C, Yang C, Fan W, Wu J, Yang D, Jin H, Yang Q, Hu G, Lin N, Yang X, Wan J, Zhang J, Wu L, Dai Y, Ma L, Li S, Su J, Sun J, Ding Y, Xiao R, Zhang S, Jiang W, Wang L, Zhang J. Ivarmacitinib for the treatment of adults with severe alopecia areata: Results from a phase 3 trial. J Am Acad Dermatol. 2026 Jan;94(1):161-171. doi: 10.1016/j.jaad.2025.09.044. Epub 2025 Sep 19.

    PubMed 40976531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR0302 in people with Alopecia Areata, run by Reistone Biopharma Company Limited at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects achieving a SALT score ≤ 20 at week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.

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