Active Ankylosing SpondylitisPhase 2NCT05814939
Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
A Phase 2 study testing VC005 tablets and Tofacitinib Citrate 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 II 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 and Tofacitinib Citrate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2023to 11 May 2024
- 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 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 (AS can be diagnosed by having Article ④ and any one of Articles ① to ③): ① lower back pain lasting for at least 3 months, with pain improving with activity but not with rest; ② limited movement of the lumbar spine in the anterior-posterior and lateral flexion directions; ③ thoracic extension less than normal for the same age and sex; ④ bilateral sacroiliac arthritis grade II-IV, or unilateral sacroiliac arthritis grade III-IV;
- The subject had active disease prior to the screening visit and randomization, defined as follows: Bath AS Disease Activity Index (BASDAI) score ≥ 4 and a spinal pain score (BASDAI question 2) ≥ 4 (see Annex 6 for scoring criteria);
- Subjects who have been treated with non-steroidal anti-inflammatory drugs (NSAIDs) and still have active disease, or who have discontinued NSAIDs due to intolerance; defined as follows: subjects must have had at least 2 cumulative inadequate clinical responses to the recommended dose (≥2 weeks of each NSAID and ≥4 weeks of total use) or intolerance to at least 2 different oral NSAIDs. Intolerance defined as discontinuation of treatment with NSAIDs due to associated adverse events (e.g., allergic reactions, gastrointestinal signs or symptoms, etc.);
- Subjects taking treatment with NASIDs at the time of screening, requiring stable dose continuation for ≥ 2 weeks prior to randomization; no change in drug dose during the study period except for emergencies; if not taking, discontinuation for at least ≥ 2 weeks prior to randomization;
Show all 9Show fewer
- If subjects are enrolled in the study on a combination of methotrexate (MTX), salazosulfapyridine (SASP) and/or hydroxychloroquine (HCQ), subjects must receive a stable dose of MTX (≤25 mg/week) and/or SASP (≤3 g/day) and/or HCQ (≤400 mg/day) for at least 28 days prior to the baseline visit. A maximum of two background csDMARDs allowed in combination;
- Subjects taking oral glucocorticoids at screening at doses ≤10 mg/day of prednisone (or equivalent doses of other glucocorticoids) that need to be continued for ≥4 weeks prior to randomization; if subjects are not taking oral glucocorticoids, they need to be off them for at least ≥4 weeks prior to randomization;
- The subject has received ≤ 1 prior treatment with a biologic agent prior to randomization. Subjects previously treated with biologic agents must have been off ≥ 6 half-lives prior to randomization.
Who cannot join
- 1. Presence of the following diseases or history of disease:
- A known or suspected history of complete spinal ankylosis, or clinically and imaging confirmed complete spinal ankylosis;
- A history of any other autoimmune rheumatic disease;
- Patients with a combination of severe extra-articular manifestations, such as hyperthermia, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, or neurological pathology;
- Patients with current or recent serious, or progressive, or uncontrolled disease, including: hepatic, renal, hematologic, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, or neurologic disease; or patients who, in the opinion of the investigator, may affect patient safety or compliance;etc.
- 2.Any of the following laboratory test indicators are met at the time of the screening test:
Show all 12Show fewer
- Those who test positive for the following bacteria or viruses at screening, such as HIV, syphilis, Hepatitis B Virus (HBSAg, HBeAg, Hepatitis B Virus-DNA, anyone positive for any of the three), Hepatitis C Virus (positive for anti-Hepatitis C Virus antibodies); If screening stage hepatitis B surface antigen negative (HBsAg-) and anti-hepatitis B core antibody positive (HBcAb+), additional quantitative Hepatitis B Virus-DNA test is required and excluded if quantitative > normal value;
- Routine blood count: white blood cell count (WBC) <3×109/L, absolute neutrophil count (ANC) <1.5×109/L, absolute lymphocyte count (ALC) <0.8×109/L, platelets (PLT) <100×109/L, hemoglobin (Hb) <100 g/L;etc.
- 3. Is taking or has a history of taking medication that:
- Those who are receiving any other csDMARDs or biologic DMARDs (except MTX, SASP, HCQ in the inclusion criteria) or other prohibited concomitant medications; if previous use of csDMARDs such as thalidomide, hydroxychloroquine or leflunomide, those who discontinued thalidomide, hydroxychloroquine, etc. for ≤ 4 weeks and leflunomide for ≤ 8 weeks prior to randomization (using criteria subjects not more than 28 days after Kauleenamine treatment or active carbon elution were not allowed to be enrolled in the trial);
- Those who have been treated with any tyrosine kinase (JAK) inhibitor (e.g. Tofacitinib, Baricitinib, Upadacitinib, etc.);etc.
- 4. Those who may be allergic to VC005, similar drugs or their excipients 5. Those with substance abuse or alcohol dependence 6. Subjects who, in the opinion of the investigator, may be at risk of gastrointestinal perforation during the course of the trial 7. Those who have participated in a clinical trial with any drug or device within 12 weeks prior to screening and have used that drug or device 8. Subjects who have a history of major surgery, joint surgery within 6 months prior to screening or who are scheduled to have surgery during the trial 9. Female patients who are planning to become pregnant or who are pregnant or breastfeeding, or who are unable to use effective contraception throughout the trial and for 3 months after the end of the trial (see Appendix 14 for details) 10. 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.
About this study
Official title: A Multicenter, Randomized, Double-blind, Controlled Phase II 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 II clinical study.
- Conditions
- Active Ankylosing Spondylitis
- Being tested
- VC005 tablets, Tofacitinib Citrate 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 12 weeks
Tofacitinib Citrate TabletsDrug
Tofacitinib Citrate groups repeat administration for 12 weeks
VC005 Tablets PlaceboDrug
VC005 placebo groups repeat administration for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets Medium Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| Tofacitinib Citrate Tablets groups | Active comparator | Not described Receives: Drug: Tofacitinib Citrate 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 ASAS20
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 posted18 Apr 2023
- Study start26 Apr 2023
- Primary completion11 May 2024
- Study completion11 May 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
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
- NCT05814939
- Sponsor's protocol ID
- VC005-201
- Status last verified
- Jul 2024
- First submitted
- 4 Apr 2023
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
- ClinicalTrials.gov ID
- NCT05814939
- Acronym / sponsor ID
- VC005-201
- Conditions
- Active Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 18 Apr 2023 (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 II clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets Medium Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Drug: VC005 tablets |
| Tofacitinib Citrate Tablets groups | Active comparator | Drug: Tofacitinib Citrate 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 (9 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 (AS can be diagnosed by having Article ④ and any one of Articles ① to ③): ① lower back pain lasting for at least 3 months, with pain improving with activity but not with rest; ② limited movement of the lumbar spine in the anterior-posterior and lateral flexion directions; ③ thoracic extension less than normal for the same age and sex; ④ bilateral sacroiliac arthritis grade II-IV, or unilateral sacroiliac arthritis grade III-IV;
- The subject had active disease prior to the screening visit and randomization, defined as follows: Bath AS Disease Activity Index (BASDAI) score ≥ 4 and a spinal pain score (BASDAI question 2) ≥ 4 (see Annex 6 for scoring criteria);
- Subjects who have been treated with non-steroidal anti-inflammatory drugs (NSAIDs) and still have active disease, or who have discontinued NSAIDs due to intolerance; defined as follows: subjects must have had at least 2 cumulative inadequate clinical responses to the recommended dose (≥2 weeks of each NSAID and ≥4 weeks of total use) or intolerance to at least 2 different oral NSAIDs. Intolerance defined as discontinuation of treatment with NSAIDs due to associated adverse events (e.g., allergic reactions, gastrointestinal signs or symptoms, etc.);
Key exclusion criteria (12 listed)
- A known or suspected history of complete spinal ankylosis, or clinically and imaging confirmed complete spinal ankylosis;
- A history of any other autoimmune rheumatic disease;
- Patients with a combination of severe extra-articular manifestations, such as hyperthermia, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, or neurological pathology;
- Patients with current or recent serious, or progressive, or uncontrolled disease, including: hepatic, renal, hematologic, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, or neurologic disease; or patients who, in the opinion of the investigator, may affect patient safety or compliance;etc.
- 2.Any of the following laboratory test indicators are met at the time of the screening test:
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 12 weeks | Drug | VC005 Tablets High Dose groups, VC005 Tablets Low Dose groups, VC005 Tablets Medium Dose groups |
| Tofacitinib Citrate TabletsTofacitinib Citrate groups repeat administration for 12 weeks | Drug | Tofacitinib Citrate Tablets groups |
| VC005 Tablets PlaceboVC005 placebo groups repeat administration for 12 weeks | Drug | VC005 Tablets Placebo groups |
Primary outcome
Percentage of patients achieving ASAS20
Time frame: Week 12
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.
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 29 Jul 2024.
Related trials for Active Ankylosing Spondylitis
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Active, not recruiting
Effects of Pulmonary Rehabilitation Exercises in Patients With Axial Spondyloarthritis
Axial Spondyloarthritis, Ankylosing Spondylitis (AS)
Not yet recruiting
Postural Biofeedback and Exercise in Axial Spondyloarthritis
Axial Spondyloarthritis (AxSpA), Ankylosing Spondylitis (AS)
RecruitingObservational study
Korean Post-marketing Surveillance for Xeljanz XR
Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis
Not yet recruitingObservational study
Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Ankylosing Spondylitis, Psoriasis
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.
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 2 study testing VC005 tablets and Tofacitinib Citrate 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 9 inclusion and 12 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 29 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?
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 of patients achieving ASAS20 (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 29 Jul 2024.