Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • VC005 tablets

    Drug

    VC005 groups repeat administration for 48 weeks

  • VC005 Tablets Placebo

    Drug

    VC005 placebo groups repeat administration for 48 weeks

Treatment groups

420 Participants
are divided into 3 treatment groups
Group A: VC005 Tablets Low Dose groupsExperimental treatment 1 intervention
Group B: VC005 Tablets High Dose groupsExperimental treatment 1 intervention
Group C: VC005 Tablets Placebo groupsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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