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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-26

Study Completion Date

2027-08-30

Brief Summary

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

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Detailed Description

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Conditions

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Active Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VC005 Tablets Low Dose groups

Group Type EXPERIMENTAL

VC005 tablets

Intervention Type DRUG

VC005 groups repeat administration for 48 weeks

VC005 Tablets High Dose groups

Group Type EXPERIMENTAL

VC005 tablets

Intervention Type DRUG

VC005 groups repeat administration for 48 weeks

VC005 Tablets Placebo groups

Group Type PLACEBO_COMPARATOR

VC005 Tablets Placebo

Intervention Type DRUG

VC005 placebo groups repeat administration for 48 weeks

Interventions

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VC005 tablets

VC005 groups repeat administration for 48 weeks

Intervention Type DRUG

VC005 Tablets Placebo

VC005 placebo groups repeat administration for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No