Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

NCT ID: NCT04840485

Last Updated: 2024-05-22

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2024-02-28

Brief Summary

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The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Detailed Description

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Conditions

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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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Treatment group A

Group Type EXPERIMENTAL

SHR-1314

Intervention Type DRUG

SHR-1314 high dose

Treatment group B

Group Type EXPERIMENTAL

SHR-1314

Intervention Type DRUG

SHR-1314 low-dose

Treatment group C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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SHR-1314

SHR-1314 high dose

Intervention Type DRUG

SHR-1314

SHR-1314 low-dose

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs

Exclusion Criteria

\- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHR-1314-302

Identifier Type: -

Identifier Source: org_study_id

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