NCT02161406

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Dinesh Khanna, MD, MS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score \[mRSS\]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.

Detailed description

This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc. Eligible participants will be randomized in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by duration of dcSSc disease duration (\<18 months vs \>18 to \</=36 months). Study participants will be treated for 12 months on double-blind study medication, followed by an additional 24 weeks of open-label SC abatacept therapy. 86 patients will be randomized in approximately 35 centers in the US, Canada and Europe, with the goal of analyzing 74 participants. The investigators study will test whether abatacept is statistically superior to placebo in reducing the MRSS at month 12 and explore the ability of abatacept to prevent or reverse progression in patients with early disease duration and lower MRSS scores, and reverse established disease in patients with longer disease duration and higher MRSS scores.

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Abatacept	Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks
DRUG	Placebo	125 mg of Placebo

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-09-12
• Completion: 2018-10-17
• First posted: 2014-06-11
• Last updated: 2020-02-17
• Results posted: 2019-06-18

Locations

27 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study