VitiligoPhase 2/3NCT04774809
Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo
A Phase 2/3 study testing Low Dose SHR0302 Ointment BID and High Dose SHR0302 Ointment BID in people with Vitiligo, run by Reistone Biopharma Company Limited at 16 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Low Dose SHR0302 Ointment BID and High Dose SHR0302 Ointment BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 16 sitesChina
- Study dates
- 29 Jan 2020to 21 Mar 2022
- Phase
- Phase 2/3
- 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
- Subjects who voluntarily signed an informed consent form.
- Ages at ≥18 and ≤ 65 years
- Clinical diagnosis of non-segmental vitiligo.
- All women and men who are likely to give birth must be willing to use at least one efficient method of contraception from the signing of the informed consent form to 1 month after the last dose of IP.
- Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit.
- Subjects who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.
Who cannot join
- Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo.
- Subjects with historical or current evidence of clinically significant disease or lab test abnormalities or with disease that require the administration of prohibited drugs in this study.
- Subjects with a malignant tumor or a history of malignant tumor (except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma).
- Pregnant or lactating female subjects;
- Subjects who have previously received JAK inhibitors therapy, systemic or oral
- Subjects who had used any biologics within12 weeks before the baseline or 5 half-lives (whichever is longer).
Show all 9Show fewer
- Subjects who participated in other interventional clinical studies within 4 weeks before the baseline visit, or who were still within 5 half-lives of the last dose of the intervention clinical study drug at baseline.
- Subjects who received a live or live-attenuated vaccination within 8 weeks before the baseline visit.
- Any other condition that causes the subject to be unfit for the study as per discretion of the investigator.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
The First Hospital of Jillin University
Changchun, 130021
West China School of Medicine
Chengdu, Sichuan
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Sun. Yai- Sen Memorial Hospital, Sun. Yai- Sen University
Guangzhou, 51000
Hangzhou Third Hospital
Hangzhou, Zhejiang
Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Jiangsu Province Hospital
Nanjing, 210006
Ningbo No.2 Hospital
Ningbo, Zhejiang
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200071
Huashan Hospital Affiliated To Fudan University
Shanghai
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Wuhan No.1 Hospital
Wuhan, Hubei
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi
About this study
Official title: A Randomized, Double-blind, Vehicle-Controlled, Phase II/Ⅲ Seamless Adaptive Clinical Trail to Evaluate the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
Read the detailed description
This study is a phase II/Ⅲ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.
- Conditions
- Vitiligo
- Being tested
- Low Dose SHR0302 Ointment BID, High Dose SHR0302 Ointment BID, Placebo Comparator: Vehicle
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose SHR0302 Ointment BIDDrug
Low Dose SHR0302 Ointment BID
High Dose SHR0302 Ointment BIDDrug
High Dose SHR0302 Ointment BID
Placebo Comparator: VehicleOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR0302 Low Dose | Active comparator | Drug: SHR0302 SHR0302 Ointment BID Low Dose Receives: Drug: Low Dose SHR0302 Ointment BID |
| SHR0302 High Dose | Active comparator | Drug: SHR0302 SHR0302 Ointment BID High Dose Receives: Drug: High Dose SHR0302 Ointment BID |
| Placebo Comparator: Vehicle | Placebo comparator | Drug: vehicle Vehicle BID Placebo Receives: Other: Placebo Comparator: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2
Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24.
Measured: 24 weeks
Phase 3
Phase 3: Percentage of subjects whose face and neck vitiligo area scoring index improved by at least 75% (F-VASI75) compared with the baseline at week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start29 Jan 2020
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Why it stopped: terminated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 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
- NCT04774809
- Sponsor's protocol ID
- RSJ10828
- Status last verified
- Jun 2022
- First submitted
- 24 Feb 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-Controlled, Phase II/Ⅲ Seamless Adaptive Clinical Trail to Evaluate the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT04774809
- Acronym / sponsor ID
- RSJ10828
- Conditions
- Vitiligo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated by sponsor
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 1 Mar 2021 (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.
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
Detailed description
This study is a phase II/Ⅲ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR0302 Low Dose | Active comparator | Drug: Low Dose SHR0302 Ointment BIDDrug: SHR0302 SHR0302 Ointment BID Low Dose |
| SHR0302 High Dose | Active comparator | Drug: High Dose SHR0302 Ointment BIDDrug: SHR0302 SHR0302 Ointment BID High Dose |
| Placebo Comparator: Vehicle | Placebo comparator | Other: Placebo Comparator: VehicleDrug: vehicle Vehicle BID Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who voluntarily signed an informed consent form.
- Ages at ≥18 and ≤ 65 years
- Clinical diagnosis of non-segmental vitiligo.
- All women and men who are likely to give birth must be willing to use at least one efficient method of contraception from the signing of the informed consent form to 1 month after the last dose of IP.
- Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit.
Key exclusion criteria (9 listed)
- Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo.
- Subjects with historical or current evidence of clinically significant disease or lab test abnormalities or with disease that require the administration of prohibited drugs in this study.
- Subjects with a malignant tumor or a history of malignant tumor (except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma).
- Pregnant or lactating female subjects;
- Subjects who have previously received JAK inhibitors therapy, systemic or oral
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 |
|---|---|---|
| Low Dose SHR0302 Ointment BIDLow Dose SHR0302 Ointment BID | Drug | SHR0302 Low Dose |
| High Dose SHR0302 Ointment BIDHigh Dose SHR0302 Ointment BID | Drug | SHR0302 High Dose |
| Placebo Comparator: VehiclePlacebo | Other | Placebo Comparator: Vehicle |
Primary outcome
Phase 2
Time frame: 24 weeks
Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24.
Phase 3
Time frame: 24 weeks
Phase 3: Percentage of subjects whose face and neck vitiligo area scoring index improved by at least 75% (F-VASI75) compared with the baseline at week 24.
Results and safety
The study was stopped early (reason given: terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low Dose SHR0302 Ointment BID and High Dose SHR0302 Ointment BID in people with Vitiligo, run by Reistone Biopharma Company Limited at 16 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 combined 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.
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?
The study was stopped early (reason given: terminated by sponsor). 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?
Phase 2 (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 13 Jul 2022.