NCT05119712

Terbinafine Treatment of Axial Spondyloarthropathy

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy

Detailed description

The purpose of this trial is to determine if terbinafine is an effective therapy for ankylosing spondylitis. Benefit will be determined by a reduction of the BASDAI by two or more. The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.

Conditions

• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Psoriatic Spondylitis
• Spondylitis Secondary to Inflammatory Bowel Disease
• Axial Spondyloarthopathy

Interventions

Type	Name	Description
DRUG	Terbinafine Tablets	500mg oral terbinafine or placebo daily
DIAGNOSTIC_TEST	Laboratory Testing	Laboratory testing at screening, baseline, week 8, 16, 24 and 32.
DIAGNOSTIC_TEST	Laboratory Testing	Subjects with the potential to become pregnant will have a baseline urine pregnancy test prior to starting study drug.

Timeline

• Start date: 2021-03-09
• Primary completion: 2023-10-15
• Completion: 2024-10-15
• First posted: 2021-11-15
• Last updated: 2023-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study