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

NCT05055934 | Completed Phase 2

• 1 other identifier: SHR-1314-204
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving ACR 20 improvement at week 12

  at week 12

Secondary Outcomes (2)

• 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

Study Arms (2)

SHR-1314 injection

EXPERIMENTAL

Drug: SHR-1314 injection

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SHR-1314 injection DRUG

SHR-1314 injection

SHR-1314 injection

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
• Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
• A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Huashan Hospital of the Shanghai FuDan University

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Xue Y, Sun L, Zhang N, Chen H, Shi X, Liu S, Chen L, Ma X, Wei H, Jiang Z, Li X, Fan H, Li H, Li J, Wu R, Shi G, Zhu J, Kong X, Lu Y, Liu P, Zheng Q, Bai X, Zhang S, Wan W, Zou H. Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study. Rheumatology (Oxford). 2026 Feb 3:keag060. doi: 10.1093/rheumatology/keag060. Online ahead of print.

  PMID: 41632483 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: October 22, 2021
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: December 12, 2024

Record last verified: 2021-09

Locations

CN (1)