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Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis

NCT02370693 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-08-25

Study results available
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Summary

The purpose of this study is to look at whether bortezomib, mycophenolate or the combination of both is better to treat scarring of the lung caused by Systemic Sclerosis.

Conditions

Interventions

DRUG

Bortezomib

Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks

DRUG

Placebo

Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks

DRUG

Mycophenolate mofetil

Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Manu Jain, MD, MSc · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-12-16
Completion
2020-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02370693 on ClinicalTrials.gov