NCT06197009

Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis

A Randomized, Double-blinded, Phase II, Placebo-controlled Study to Evaluate the Safety and Efficacy of SCT650C in Participants With Axial Spondyloarthritis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Axial Spondyloarthritis

Detailed description

This is a multicenter, Phase II, double-blinded, placebo-controlled study to evaluate the safety and efficacy of SCT650C in Participants with Axial Spondyloarthritis. This study includes 4 periods (Screening period, Loading period, Maintenance period and Follow-up period), and 168 participants in 4 groups (Group 1, 2, 3 and 4).

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	SCT650C	Administered SC

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-01-09
• Last updated: 2024-01-09

Locations

1 site across 1 country: Turkey (Türkiye)