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Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis

NCT ID: NCT05055934

Last Updated: 2024-12-12

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

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2024-06-05

Brief Summary

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This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1314 injection

Group Type EXPERIMENTAL

SHR-1314 injection

Intervention Type DRUG

SHR-1314 injection

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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SHR-1314 injection

SHR-1314 injection

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
3. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
4. There is active PsA before randomization;
5. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;

Exclusion Criteria

1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Huashan Hospital of the Shanghai FuDan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHR-1314-204

Identifier Type: -

Identifier Source: org_study_id