Active Ankylosing SpondylitisPhase 3NCT07172360
Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
A Phase 3 study testing VC005 tablets in people with Active Ankylosing Spondylitis, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Ankylosing Spondylitis
- What is being tested?
- VC005 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 30 Aug 2027
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject understands and voluntarily signs the informed consent form (ICF) and is willing and able to comply with the study protocol;
- The subject is between 18 and 70 years of age (including borderline values) at the time of signing the ICF, regardless of gender;
- The subject has been diagnosed with AS according to the 1984 New York Revised Criteria for Ankylosing Spondylitis
Who cannot join
- Those who may be allergic to VC005, similar drugs or their excipients.
- Individuals who have undergone organ transplantation in the past and require continuous use of immunosuppressants.
- Those who, for any reason, are considered by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Zhanguo Li, 13910713924, Zgli99@aliyun.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Active Ankylosing Spondylitis
This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.
- Conditions
- Active Ankylosing Spondylitis
- Being tested
- VC005 tablets, VC005 Tablets Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 tabletsDrug
VC005 groups repeat administration for 48 weeks
VC005 Tablets PlaceboDrug
VC005 placebo groups repeat administration for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets Placebo groups | Placebo comparator | Not described Receives: Drug: VC005 Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving an Assessment of disease activity (signs and symptoms) in ankylosing spondylitis 20% improvement (ASAS20) in response at week 12 of treatment.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start26 Dec 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhanguo Li, Principal investigator, Peking University People's HospitalXu Liu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172360
- Sponsor's protocol ID
- VC005-301
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07172360
- Acronym / sponsor ID
- VC005-301
- Conditions
- Active Ankylosing Spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 15 Sep 2025 (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 clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets Placebo groups | Placebo comparator | Drug: VC005 Tablets Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject understands and voluntarily signs the informed consent form (ICF) and is willing and able to comply with the study protocol;
- The subject is between 18 and 70 years of age (including borderline values) at the time of signing the ICF, regardless of gender;
- The subject has been diagnosed with AS according to the 1984 New York Revised Criteria for Ankylosing Spondylitis
Key exclusion criteria (3 listed)
- Those who may be allergic to VC005, similar drugs or their excipients.
- Individuals who have undergone organ transplantation in the past and require continuous use of immunosuppressants.
- Those who, for any reason, are considered by the investigator to be unsuitable for participation in this 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 |
|---|---|---|
| VC005 tabletsVC005 groups repeat administration for 48 weeks | Drug | VC005 Tablets High Dose groups, VC005 Tablets Low Dose groups |
| VC005 Tablets PlaceboVC005 placebo groups repeat administration for 48 weeks | Drug | VC005 Tablets Placebo groups |
Primary outcome
Percentage of patients achieving an Assessment of disease activity (signs and symptoms) in ankylosing spondylitis 20% improvement (ASAS20) in response at week 12 of treatment.
Time frame: week 12
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 2 Jan 2026.
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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.
Zhanguo Li principal investigator
Peking University People's Hospital
Xu Liu principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VC005 tablets in people with Active Ankylosing Spondylitis, run by Jiangsu vcare pharmaceutical technology 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 3 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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 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?
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 xiaojuan lai (15358160458, lai_xiaojuan@vcarepharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving an Assessment of disease activity (signs and symptoms) in ankylosing spondylitis 20% improvement (ASAS20) in response at week 12 of treatment. (time frame: week 12). 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 2 Jan 2026.