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

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called SHR-1314 to see how well it works and how safe it is for adults with active psoriatic arthritis (PsA). PsA is a type of arthritis that affects some people who have psoriasis, a skin condition that causes red, scaly patches. The study will enroll about 150 adult participants who will be randomly assigned to receive either the SHR-1314 treatment or a placebo (a treatment that looks the same but has no active ingredients). The trial involves several phases, including a 4-week screening to determine eligibility, followed by 24 weeks of treatment, and then an additional 24 weeks of maintenance treatment, plus an 8-week safety follow-up.

To participate, individuals must be adults aged 18 or older who have been diagnosed with active psoriatic arthritis and have signs of plaque psoriasis, which is characterized by raised, red patches on the skin. They should not have any other serious health issues or have recently received certain treatments for their condition. Participants can expect regular check-ups during the study to monitor their health and the effects of the medication. This study is currently recruiting participants and aims to provide valuable information about the potential benefits of SHR-1314 for managing psoriatic arthritis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
• • 2. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR)；
• • 3. There is active PsA before randomization;
• • 4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
• • 5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.
• 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.