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Evaluating Sirolimus to Treat Autoimmune Blistering Dermatosis Pemphigus

NCT01313923 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-06-09

Study results available
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Summary

The purpose of this research is to study alternative treatments for the skin disease pemphigus (a rare autoimmune blistering disorder of the skin) by using sirolimus, an immunosuppressive drug. Immunosuppressive drugs inhibit or prevent the activity of the immune system and are commonly used to treat autoimmune diseases, inflammatory diseases, and organ transplantation rejection.

Conditions

  • Pemphigus

Interventions

DRUG

Sirolimus (formerly known as Rapamycin)

For low to moderate immunologic risk, the loading dose is 6mg immediately after transplantation, followed by 2mg PO Qday in conjunction with cyclosporine and corticosteroids. After 2-4 months, cyclosporine should be discontinued over 4-8 weeks while titrating sirolimus drug concentrations within the target-range with whole blood trough concentrations every 1-2 weeks. Monitoring is needed because cyclosporine inhibits the metabolism of sirolimus, and discontinuation of cyclosporine can lead to lower levels of sirolimus. In high immunologic risk patients, the loading dose is 15mg after transplantation, followed by 5mg PO Qday in conjunction with cyclosporine and corticosteroids for 12 months. A whole blood trough level is recommended between days 5 and 7 with adjustment to the daily dose.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Sergei Grando, MD, PhD · University of California, Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01313923 on ClinicalTrials.gov