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

Jiangsu Vcare PharmaTech

Status and phase: Enrolling; Phase 3

Conditions: Active Ankylosing Spondylitis

Treatments: Drug: VC005 Tablets Placebo; Drug: VC005 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07172360

VC005-301

Details and patient eligibility

About

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

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 3 patient groups, including a placebo group

VC005 Tablets Low Dose groups

Experimental group

Treatment:

Drug: VC005 tablets

VC005 Tablets High Dose groups

Experimental group

Treatment:

Drug: VC005 tablets

VC005 Tablets Placebo groups

Placebo Comparator group

Treatment:

Drug: VC005 Tablets Placebo