NCT04008069

Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

A Phase II, Single-Site, Double-Blind, Placebo-Controlled Randomized Withdrawal Study Assessing the Efficacy and Safety of Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis.

Detailed description

The purpose of this study is to compare the effectivness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis. To demonstrate that sarilumab treatment will be effective for inducing and maintaining glucocorticoid-free remission in male or female patients with biopsy proven active, glucocorticoid-dependent sarcoidosis affecting the lungs, lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	Sarilumab	Sarilumab 200 mg administered subcutaneously
DRUG	Placebo	Placebo administered subcutaneously

Timeline

• Start date: 2019-09-03
• Primary completion: 2022-07-26
• Completion: 2022-09-09
• First posted: 2019-07-05
• Last updated: 2023-10-05
• Results posted: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study