Severe Alopecia AreataPhase 2NCT06562894
Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients
A Phase 2 study testing SYHX1901 in people with Severe Alopecia Areata, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of severe alopecia areata. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Alopecia Areata
- 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
- 156 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2025to 17 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 fully understand and voluntarily participate in this study and sign informed consent;
- Subjects aged ≥18 to ≤ 65 years;
- Clinical diagnosis of alopecia areata,with at least 50% scalp hair loss，as defined by a SALT score ≥50 at screening and baseline visit;
- The current episode of hair loss was less than 10 years ago, and there was no evidence of spontaneous hair regrowth within 6 months before screening (the overall duration of alopecia areata more than 10 years could be included);
- Subjects must be volunteer and be able to understand informed consent Forms;
- Subjects and their partners should voluntarily take contraceptive measures considered effective by the investigator during the study period and for at least 28 days after the study;
Who cannot join
- Participants who have received hair implants;
- Alopecia caused by other reasons;
- Other active scalp or systemic diseases that may cause severe alopecia or affect the clinical evaluation of alopecia areata;
- Participants who have shaved their heads;
- Participants who have a clinically significant (as assessed by the investigator) abnormality in TSH or free T4 at screening and who were deemed by the investigator to be ineligible for the study;
- Participants who wore stick-on wigs and refused to stop wearing them during the study;
Show all 23Show fewer
- Bacterial, fungal, or viral infection requiring hospitalization/intravenous treatment within 4 weeks before the first dose of study drug or requiring oral treatment within 2 weeks before the first dose of study drug;
- Have any chronic infection that requires systemic anti-infective therapy;
- Have received a live vaccine within 60 days before the first dose of the study drug or plan to receive a live vaccine between the middle of the study and 60 days after the end of the study;
- History of severe herpes zoster or sever herpes simplex infection;
- HBV-related tests are abnormal at screening;
- HCV antibody positive and HCV RNA positive at screening;
- Human immunodeficiency virus antibody positive or treponema pallidum antibody positive;
- Any known or suspected condition of congenital or acquired immunodeficiency;
- Previous or current active tuberculosis infection or latent tuberculosis infection (LTBI) deemed by the investigator/specialist to require treatment;
- Major surgery within 8 weeks prior to first dose of the study drug or planned surgery during the study;
- Organ transplantation (except corneal transplantation more than 3 months before the initiation of the investigational drug);
- Symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain disease, or with other chronic diseases that the investigator has determined are not suitable for participation in this clinical trial;
- History of malignancy or lymphoproliferative disease;
- Uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg after systemic treatment;
- Having unstable cardiovascular disease defined as presence of a clinical cardiovascular event in the last 3 months or hospitalized for heart disease within the last 3 months; or NYHA≥grade 3, or abnormal ECG suggesting clinically significant and assessed by the investigator as carrying unforeseen risks;
- Patients with a history of arterial or venous thrombosis or high risk factors for thrombosis within 6 months before the first dose of study drug;
- Combined with active lipid-lowering drugs but poorly controlled hyperlipidemia: total cholesterol (TC)≥ 6.2mmol/L or low-density lipoprotein cholesterol (LDL-C)≥3.4mmol/L; or familial hypercholesterolemia (FH);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYHX1901 Tablets in the Treatment of Severe Alopecia Areata
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of severe alopecia areata.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of two different doses of SYHX1901 tablets compared with placebo in the treatment of severe alopecia areata. The total duration of the study will be 56 60 weeks which will be comprised of: a screening period (4 weeks); a core treatment period (24 weeks),a extended treatment period（28 weeks）and a follow-up assessment period (4 weeks). Eligible subjects will be randomly assigned to SYHX1901 dose 1 , dose 2，dose 3 or placebo group at a 1:2:2:1 ratio for continuous oral administration for 24 weeks, then placebo group will receive SYHX1901 at dose 3 for 28 weeks, the SYHX1901 dose 1, dose 2，dose 3 group will remain the same dose for 28 weeks. The SALT（Severity of AlLopecia Tool） score will be a stratification factor. Subjects will be monitored for the safety throughout the study.
- Conditions
- Severe Alopecia Areata
- Being tested
- SYHX1901, Placebo
- Keywords
- plaque psoriasis
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX1901Drug
Administered orally, once daily (QD)
PlaceboDrug
Administered orally, once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| SYHX1901 dose 1 | Experimental | Not described Receives: Drug: SYHX1901 |
| SYHX1901 dose 2 | Experimental | Not described Receives: Drug: SYHX1901 |
| SYHX1901 dose 3 | Experimental | Not described Receives: Drug: SYHX1901 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%
Percentage of subjects achieving a SALT score < or = 20% at week 24
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 posted20 Aug 2024
- Study start26 May 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion17 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Alopecia AreataStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562894
- Sponsor's protocol ID
- SYHX1902-006
- Status last verified
- May 2025
- First submitted
- 18 Aug 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYHX1901 Tablets in the Treatment of Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT06562894
- Acronym / sponsor ID
- SYHX1902-006
- Conditions
- Severe Alopecia Areata
- Keywords
- plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Study start
- 26 May 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 17 Nov 2027 (estimated)
- First posted
- 20 Aug 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.
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of severe alopecia areata.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of two different doses of SYHX1901 tablets compared with placebo in the treatment of severe alopecia areata. The total duration of the study will be 56 60 weeks which will be comprised of: a screening period (4 weeks); a core treatment period (24 weeks),a extended treatment period（28 weeks）and a follow-up assessment period (4 weeks). Eligible subjects will be randomly assigned to SYHX1901 dose 1 , dose 2，dose 3 or placebo group at a 1:2:2:1 ratio for continuous oral administration for 24 weeks, then placebo group will receive SYHX1901 at dose 3 for 28 weeks, the SYHX1901 dose 1, dose 2，dose 3 group will remain the same dose for 28 weeks. The SALT（Severity of AlLopecia Tool） score will be a stratification factor. Subjects will be monitored for the safety throughout the study.
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 |
|---|---|---|
| SYHX1901 dose 1 | Experimental | Drug: SYHX1901 |
| SYHX1901 dose 2 | Experimental | Drug: SYHX1901 |
| SYHX1901 dose 3 | Experimental | Drug: SYHX1901 |
| Placebo | Placebo comparator | Drug: 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 fully understand and voluntarily participate in this study and sign informed consent;
- Subjects aged ≥18 to ≤ 65 years;
- Clinical diagnosis of alopecia areata,with at least 50% scalp hair loss，as defined by a SALT score ≥50 at screening and baseline visit;
- The current episode of hair loss was less than 10 years ago, and there was no evidence of spontaneous hair regrowth within 6 months before screening (the overall duration of alopecia areata more than 10 years could be included);
- Subjects must be volunteer and be able to understand informed consent Forms;
Key exclusion criteria (23 listed)
- Participants who have received hair implants;
- Alopecia caused by other reasons;
- Other active scalp or systemic diseases that may cause severe alopecia or affect the clinical evaluation of alopecia areata;
- Participants who have shaved their heads;
- Participants who have a clinically significant (as assessed by the investigator) abnormality in TSH or free T4 at screening and who were deemed by the investigator to be ineligible for the study;
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 |
|---|---|---|
| SYHX1901Administered orally, once daily (QD) | Drug | SYHX1901 dose 1, SYHX1901 dose 2, SYHX1901 dose 3 |
| PlaceboAdministered orally, once daily (QD) | Drug | Placebo |
Primary outcome
Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%
Time frame: Week 24
Percentage of subjects achieving a SALT score < or = 20% at week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Severe Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
Alopecia Areata
RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
Alopecia Areata
RecruitingPhase 3
A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 1
A Phase I Study of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata
Alopecia Areata
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYHX1901 in people with Severe Alopecia Areata, run by CSPC Ouyi Pharmaceutical Co., Ltd..
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 23 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: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20% (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 3 Jun 2025.