Alopecia AreataPhase 2NCT04346316
A Phase II Study in Patients With Alopecia Areata
A Phase 2 study testing SHR0302 in people with Alopecia Areata, run by Reistone Biopharma Company Limited at 34 sites in 3 countries.
Trial summary
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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 13 May 2020to 29 Jun 2021
- Phase
- Phase 2
- 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 between 18-65 years of age (both inclusive), at the time of informed consent;
- Must have moderate to severe alopecia areata.
Who cannot join
- 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 locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
China21 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Chongqing Traditional Chinese medicine Hospital
Chongqing, Chongqing Municipality, 400011
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510030
The Dermatology Hospital of Nanfang Medical University
Guangzhou, Guangdong
The Dermatology Hospital of Nanfang Medical University
Guangzhou, Guangzhou
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
Jiangsu Province People's Hospital
Nanjin, Jiangsu, 210029
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200071
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
United States7 sites
Moore Clinical Research
Brandon, Florida, 33511
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250
The Skin Wellness Center
Knoxville, Tennessee, 37922
Dermatologists of Southwest Ohio
Mason, Ohio, 45040
Quest Dermatology Research
Northridge, California, 91324
Skin Search of Rochester, Inc
Rochester, New York, 14623
Progressive Clinical Research
San Antonio, Texas, 78213
Australia6 sites
Skin Health Institute
Carlton, Victoria, 3053
Sinclair Dermatology
East Melbourne, Victoria, 3002
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217
Novatrials
Kogarah, New South Wales, 2289
Sinclair Dermatology
Melbourne, Victoria, 3002
Veracity Clinical Research
Woolloongabba, Queensland, 4102
About this study
Official title: A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata
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.
Read the detailed 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.
- Conditions
- Alopecia Areata
- Being tested
- SHR0302
- 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
Oral tablets taken once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| SHR0302 Dose#1 | Active comparator | Not described Receives: Drug: SHR0302 |
| SHR0302 Dose#2 | Active comparator | Not described Receives: Drug: SHR0302 |
| SHR0302 Dose#3 | Active comparator | Not described Receives: Drug: SHR0302 |
| Placebo | Placebo comparator | Not described Receives: Drug: SHR0302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Severity of Alopecia Tool (SALT) score
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start13 May 2020
- Primary completion10 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346316
- Sponsor's protocol ID
- RSJ10521
- Status last verified
- Nov 2020
- First submitted
- 7 Jan 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata
- ClinicalTrials.gov ID
- NCT04346316
- Acronym / sponsor ID
- RSJ10521
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 May 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR0302 Dose#1 | Active comparator | Drug: SHR0302 |
| SHR0302 Dose#2 | Active comparator | Drug: SHR0302 |
| SHR0302 Dose#3 | Active comparator | Drug: SHR0302 |
| Placebo | Placebo comparator | Drug: SHR0302 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR0302Oral tablets taken once daily (QD) | Drug | Placebo, SHR0302 Dose#1, SHR0302 Dose#2, SHR0302 Dose#3 |
Primary outcome
Percentage change from baseline in Severity of Alopecia Tool (SALT) score
Time frame: week 24
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR0302 in people with Alopecia Areata, run by Reistone Biopharma Company Limited at 34 sites in 3 countries.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China, United States, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change from baseline in Severity of Alopecia Tool (SALT) score (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2021.