NCT03215927

Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease

A Randomized, Controlled Pilot Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Treating Interstitial Lung Disease Associated With the Anti-synthetase Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Rohit Aggarwal, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome.

Detailed description

This is a proof of concept study to evaluate the efficacy, safety and tolerability of abatacept in Syn-ILD in a multi-center randomized, placebo-controlled 6-month (24-week) pilot study.

Conditions

• Myositis
• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Abatacept	Abatacept 125mg subcutaneous weekly
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-05-30
• Completion: 2023-07-30
• First posted: 2017-07-12
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study