Phase II Study to Assess the Safety and Effectiveness of 608 Injections for Adults with Non-radiographic Axial Spondyloarthritis

What this Trial Is About

Researchers are studying the effects and safety of a drug called 608 in people with non-radiographic axial spondyloarthritis nr-axSpA, a type of inflammatory spine condition. This phase II clinical trial aims to compare 608 with a placebo to see how well it works and how tolerable it is for patients. The study is sponsored by Sunshine Guojian Pharmaceutical Shanghai Co., Ltd. and follows strict protocols to assess treatment outcomes. Participants are randomly assigned to one of three groups two groups receive different doses of 608 by subcutaneous injection, and the third group receives a placebo injection. The study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. The main treatment period lasts 16 weeks, during which the drugs effects on symptoms and inflammation are measured. During the trial, participants will attend regular visits for assessments including clinical evaluations and blood tests to measure drug levels and inflammation markers. The primary measure is the percentage of participants achieving a 40% improvement on the Assessment of Spondylo Arthritis International Society ASAS criteria by week 16. Secondary measures include a 20% improvement on ASAS criteria and drug concentration in the blood up to week 24. Safety and tolerability are closely monitored throughout the study, which is expected to conclude by November 2025.

A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)