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Terbinafine Treatment of Axial Spondyloarthropathy | Clinical Trials | Clareo Health

WITHDRAWNEARLY_PHASE1

Terbinafine Treatment of Axial Spondyloarthropathy

NCT05119712•Oregon Health and Science University

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects age 18 and older of either sex will be included.
•Subjects must be willing and able to provide informed consent.
•Subjects must have been diagnosed with ankylosing spondylitis, axial spondyloarthritis, psoriatic spondylitis or spondylitis secondary to inflammatory bowel disease by a physician and must be willing to request records to validate the diagnosis.
•Subjects must complete a symptom questionnaire called a BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and must have a score of four or above to indicate active disease and the potential to improve.
•Subjects must agree to remain on a stable treatment regimen for their joint disease for the duration of the trial and for one month before the study begins.
•Subjects must be willing to provide stool samples and be willing to have routine lab studies every 8 weeks during the duration of the study.

Exclusion Criteria

•Pregnant or lactating women will not be included.
•Subjects must not be allergic or intolerant to terbinafine.
•Subjects must not be taking medications that have the potential for serious interactions with terbinafine. These drugs include desipramine, cimetidine, fluconazole, cyclosporine and rifampin.
•Subjects must not have taken antibiotics within 3 months of starting the study drug and collecting the baseline stool specimen.
•Subjects with the following blood dyscrasias will not be included:
•Hemoglobin \<9g/dL or Hematocrit \<30% White blood cell count \<3.0 K/cu mm Absolute neutrophil count \<1.2 K/cu mm Platelet count \<100 K/cu mm Subjects with an estimated GFR ≤50 ml/min Subjects with a total bilirubin, AST, or ALT more than 1.5 times the upper limit of normal at screening.
•Severe, progressive, or uncontrolled chronic liver disease including fibrosis, cirrhosis, or recent or active hepatitis.
•History of any lymphoproliferative disorder such as Epstein Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggest of current lymphatic disease.
•Current malignancy or history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
•Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
+2 more criteria

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

March 9, 2021

Primary Completion Date

October 15, 2023

Completion Date

October 15, 2024

Last Updated

August 28, 2023

Conditions

Ankylosing SpondylitisAxial SpondyloarthritisPsoriatic SpondylitisSpondylitis Secondary to Inflammatory Bowel DiseaseAxial Spondyloarthopathy

Interventions

Terbinafine Tablets

DRUG

Laboratory Testing

DIAGNOSTIC_TEST

Laboratory Testing

DIAGNOSTIC_TEST

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Terbinafine Treatment of Axial Spondyloarthropathy

Inclusion Criteria

Exclusion Criteria

Rheumatology Patient Registry and Biorepository

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