NCT03274076

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc). This trial is intended to provide safety, and tolerability data in participants with dcSSc when dosed to target exposures similar to that used in adult participants with rheumatoid arthritis.

Detailed description

The purpose of this clinical research study is to evaluate the safety, tolerability and efficacy of treatment with tofacitinib (study drug) versus placebo (a substance with no active ingredients and therefore may have no treatment benefit) in people with diffuse cutaneous systemic scleroderma. Subjects will be randomized to tofacitinib vs. placebo in a 2:1 ratio at 5 mg twice a day for 24 weeks. Subjects will then be offered to participate in an open label phase during which they will receive tofacitinib 5 mg twice a day for 24 weeks.

Conditions

• Systemic Sclerosis
• Scleroderma

Interventions

Type	Name	Description
DRUG	Tofacitinib	Oral medication tofacitinib 5 mg twice a day for 24 weeks.
DRUG	Placebo Oral Tablet	Oral Placebo 5 mg twice a day for 24 weeks

Timeline

• Start date: 2017-09-25
• Primary completion: 2019-04-08
• Completion: 2019-11-15
• First posted: 2017-09-06
• Last updated: 2020-05-08
• Results posted: 2020-05-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study