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

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05055934

Enrollment

112

Registered

2021-09-24

Start date

2021-10-22

Completion date

2024-06-05

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief summary

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.

Interventions

DRUGSHR-1314 injection

SHR-1314 injection

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving ACR 20 improvement at week 12	at week 12

Secondary

Measure	Time frame
The proportion of subjects who achieved ACR 50 improvement (week 12)	week 12
The proportion of subjects who achieved ACR 70 improvement (week 12)	week 12

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026