NCT01487551

An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757. The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the plasma levels of ABR-215757 during the study.

Detailed description

This is an open label single arm Phase II study in patients with progressive SSc. Patients will be treated with ABR-215757 for 8 weeks. Assessment of biomarkers, disease activity and safety parameters will be performed during treatment. Patients will be offered to continue in an open label extension.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	paquinimod	Hard gelatine capsules 3.0 mg/day for 8 weeks

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-12-07
• Last updated: 2014-08-27

Locations

6 sites across 3 countries: Germany, Sweden, Switzerland