NCT03957681

A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

A Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin Thickening

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening

Conditions

• Moderate to Severe Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	KHK4827	210 mg Q2W, SC
DRUG	Placebo	Q2W, SC

Timeline

• Start date: 2019-05-23
• Primary completion: 2020-10-16
• Completion: 2025-04-11
• First posted: 2019-05-21
• Last updated: 2025-07-11

Locations

6 sites across 1 country: Japan