A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis

NCT06640257 | Recruiting Phase 3

• 1 other identifier: SHR-1314-308
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving ACR 20 improvement at week 24

  Week 24

Secondary Outcomes (2)

• The proportion of subjects who achieved ACR 50 improvement

  Week 24

• The proportion of subjects who achieved ACR 70 improvement

  Week 24

Study Arms (2)

SHR-1314 injection

EXPERIMENTAL

Drug: SHR-1314 injection

placebo

PLACEBO COMPARATOR

Drug: SHR-1314 injection; Drug: Placebo

Interventions

SHR-1314 injection DRUG

SHR-1314 injection

SHR-1314 injection; placebo

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 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;
• 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;
• Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.

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

RECRUITING

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

Central Study Contacts

Su Zhang, M.M

CONTACT

0518-82342973; su.zhang.sz3@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: October 10, 2024
• First Posted: October 15, 2024
• Study Start: November 4, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-10

Locations

CN (1)