Tofacitinib for Inflammatory Eye Disease

NCT03580343 | Unknown Phase 2 Results FDA Drug

• 1 other identifier: tofacitinib_eye_disease
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Non-infectious inflammatory eye disease, such as uveitis and scleritis, is a chronic, auto-immune process that leads to vision loss. While steroids are effective in the short term, the side-effect profile of chronic steroid use necessitates the identification of effective steroid-sparing therapies. Tofacitinib is a small molecule that inhibits the signaling pathways of multiple inflammatory cytokines. The investigators plan to evaluate whether tofacitinib may have efficacy for patients with uveitis and / or scleritis.

Conditions

Uveitis; Scleritis

Outcome Measures

Primary Outcomes (1)

• Treatment Failure (Composite Outcome)

  new inflammatory lesions relative to baseline OR 2-step increase in anterior chamber cell or vitreous haze OR worsening of visual acuity by two or more rows on ETDRS chart

  180 days

Study Arms (1)

Tofacitinib Treatment

EXPERIMENTAL

11mg extended-release tofacitinib, once daily, oral

Drug: tofacitinib

Interventions

tofacitinib DRUG

tofacitinib extended release, 11mg, daily, oral

Also known as: TOFA

Tofacitinib Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of uveitis
• a clinical response to steroids
• active disease requiring at least 10mg of prednisone daily (or steroid equivalent)

You may not qualify if:

• suspected or confirmed ocular infection
• chronic or recurring infections, such as HIV
• renal insufficiency that would preclude safe administration of tofacitinib

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Uveitis; Scleritis

Interventions

tofacitinib; 5-(tetradecyloxy)-2-furancarboxylic acid

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Scleral Diseases

Results Point of Contact

• Title: Lynn Hassman, Assistant Professor and Study PI
• Organization: Washington University in St. Louis

lhassman@wustl.edu

3142730341

Study Officials

• Lynn M Hassman, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: April 4, 2019
• Primary Completion: December 1, 2019
• Study Completion: April 4, 2021
• Last Updated: February 1, 2021
• Results First Posted: February 1, 2021

Record last verified: 2021-01

Locations

US (1)