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Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis

NCT03793439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-02-18

Study results available
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Summary

This is a pilot study to determine whether further research is warranted to assess whether tofacitinib is an effective steroid sparing treatment for pulmonary sarcoidosis. The primary endpoint for this study is a 50% or greater reduction in corticosteroid requirement.

Conditions

  • Sarcoidosis, Pulmonary
  • Sarcoidosis Lung
  • Sarcoidosis

Interventions

DRUG

Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial

Tofacitinib 5mg oral table twice daily for 16 weeks

DIAGNOSTIC_TEST

Spirometry

Spirometry testing at baseline, week 4, week 8, week 12, and week 16

GENETIC

RNA Sequencing

RNA sequencing test at baseline and week 16

DIAGNOSTIC_TEST

Laboratory testing

Laboratory testing at baseline and weeks 2, 4, 8, 12 and 16

DRUG

Corticosteroid

Taper corticosteroids starting at week 4

DRUG

Tofacitinib 5mg [Xeljanz] 1 year open-label extension

After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jim Rosenbaum, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2020-06-24
Completion
2021-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03793439 on ClinicalTrials.gov