Non-segmental VitiligoPhase 2NCT06511739
A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
A Phase 2 study testing SYHX1901 in people with Non-segmental Vitiligo, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- SYHX1901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 1 Oct 2025
- 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
- Willing to sign an ICF, able to comprehend and comply with the study procedures.
- Male or female subjects aged 18 to 65，inclusive.
- Subjects with a clinical diagnosis of non-segmental vitiligo.
- Agree to stop all other treatments for vitiligo during the study period.
- Women of child-bearing potential must have a negative serum pregnancy test within 3 days prior to the first study agent administration.
Who cannot join
- Diagnosed as other active depigmentation disease.
- At screening or baseline visits, subject exhibits active inflammatory dermatologic disease or symptoms that in the opinion of investigators would interfere of vitiligo evaluation or response to treatment.
- Uncontrolled thyroid function at screening as determined by the investigator.
- Use of permanent depigmentation treatment or skin grafts.
- Use of phototherapy, topical or systemic treatments within certain time frame prior to Day1.
- Have active bacterial/virus/other pathogens infection or infestation that require medical intervention.
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- Have progressive or uncontrolled systemic disease, or other concomitant chronic disease that the investigators believe unsuitable to participate the study.
- History of alcohol and drug abuse within one year prior to screening; History of neurological or mental disorders with diagnosis records, such as severe depression, suicidal tendencies, epilepsy, dementia, etc.
- Have any other reasons determined by the investigator that the subject is not eligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical Trials Information Group
Shijiazhuang
Clinical Trials Information Group officer, 86-0311-69085587, ctr-contact@cspc.cn
About this study
Official title: A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
Read the detailed description
SYHX1901 tablet is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 144 participants aged 18-65 with non-segmental vitiligo in 4 treatment arms. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.
- Conditions
- Non-segmental Vitiligo
- Being tested
- SYHX1901, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX1901Drug
SYHX1901 tablet
placeboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| SYHX1901-A | Experimental | Participants in this group will receive dose A of SYHX1901 orally once daily (QD) for 52 weeks Receives: Drug: SYHX1901 |
| SYHX1901-B | Experimental | Participants in this group will receive dose B of SYHX1901 orally QD for 52 weeks Receives: Drug: SYHX1901 |
| SYHX1901-C | Experimental | articipants in this group will receive dose C of SYHX1901 orally QD for 52 weeks Receives: Drug: SYHX1901 |
| Placebo followed by dose C of SYHX1901 | Placebo comparator | Participants in this group will receive placebo orally QD for 24 weeks followed by dose C of SYHX1901 orally QD for 28 weeks. Receives: Drug: SYHX1901; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5.
Measured: At 24 weeks
Secondary outcomes (7)
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5.
Measured: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)
The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5.
Measured: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.
Measured: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percent Change From Baseline in F-VASI
The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.
Measured: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percent Change From Baseline in BSA
The BSA is measured by the number of hand units (palm plus 5 digits = 1% body surface area).
Measured: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Change from baseline in Overall Dermatology Life Quality Index (DLQI) score
The DLQI is a validated questionnaire used in dermatology clinical trials as patient reported outcome measure. The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.
Measured: At 8、16、24、32、40、48、52、56 weeks
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
The HADS is a self-rating patient reported outcome measure (PROM) to assess depression and anxiety in patients. Fourteen items are equally divided in two subscales: anxiety (HADS-A) and depression (HADS-D).
Measured: At 8、16、24、32、40、48、52、56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start27 May 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- Parallel assigned
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511739
- Sponsor's protocol ID
- SYHX1902-004
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
- ClinicalTrials.gov ID
- NCT06511739
- Acronym / sponsor ID
- SYHX1902-004
- Conditions
- Non-segmental Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 22 Jul 2024 (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.
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
Detailed description
SYHX1901 tablet is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 144 participants aged 18-65 with non-segmental vitiligo in 4 treatment arms. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel assigned
| Arm | Type | Receives |
|---|---|---|
| SYHX1901-A | Experimental | Drug: SYHX1901Participants in this group will receive dose A of SYHX1901 orally once daily (QD) for 52 weeks |
| SYHX1901-B | Experimental | Drug: SYHX1901Participants in this group will receive dose B of SYHX1901 orally QD for 52 weeks |
| SYHX1901-C | Experimental | Drug: SYHX1901articipants in this group will receive dose C of SYHX1901 orally QD for 52 weeks |
| Placebo followed by dose C of SYHX1901 | Placebo comparator | Drug: SYHX1901, Drug: placeboParticipants in this group will receive placebo orally QD for 24 weeks followed by dose C of SYHX1901 orally QD for 28 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to sign an ICF, able to comprehend and comply with the study procedures.
- Male or female subjects aged 18 to 65，inclusive.
- Subjects with a clinical diagnosis of non-segmental vitiligo.
- Agree to stop all other treatments for vitiligo during the study period.
- Women of child-bearing potential must have a negative serum pregnancy test within 3 days prior to the first study agent administration.
Key exclusion criteria (9 listed)
- Diagnosed as other active depigmentation disease.
- At screening or baseline visits, subject exhibits active inflammatory dermatologic disease or symptoms that in the opinion of investigators would interfere of vitiligo evaluation or response to treatment.
- Uncontrolled thyroid function at screening as determined by the investigator.
- Use of permanent depigmentation treatment or skin grafts.
- Use of phototherapy, topical or systemic treatments within certain time frame prior to Day1.
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 |
|---|---|---|
| SYHX1901SYHX1901 tablet | Drug | Placebo followed by dose C of SYHX1901, SYHX1901-A, SYHX1901-B, SYHX1901-C |
| placeboOral tablet | Drug | Placebo followed by dose C of SYHX1901 |
Primary outcome
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
Time frame: At 24 weeks
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5.
7 secondary outcomes
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
Time frame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)
Time frame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
Time frame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percent Change From Baseline in F-VASI
Time frame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Percent Change From Baseline in BSA
Time frame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
Change from baseline in Overall Dermatology Life Quality Index (DLQI) score
Time frame: At 8、16、24、32、40、48、52、56 weeks
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Time frame: At 8、16、24、32、40、48、52、56 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYHX1901 in people with Non-segmental Vitiligo, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) (time frame: At 24 weeks). 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 22 Jul 2024.