NCT03365869

A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis

A Phase Ⅱ Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to examine the safety and effectiveness of sirolimus treatment for people with systemic sclerosis. The investigators perform a multi-centre, double-blind pilot trial with sirolimus in SSc.The investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).

Detailed description

Each SSc patients (n=72) received sirolimus or placebo (active group: placebo group =1:1, 2mg/day， oral administration, (SIR 2mg, po., Qd) . The end points were the changement of modified RSS and the adverse events or severe adverse events onset.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Sirolimus	Sirolimus or placebo were added to patients every day

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-12-31
• Completion: 2019-06-30
• First posted: 2017-12-07
• Last updated: 2017-12-07