CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Bortezomib +2 moredrug
Likely dose
Bortezomib 1.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02370693
NCT02370693Phase 2Completed
CompareCT.gov

Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558

Northwestern University·interventional·Posted Feb 25, 2015·Updated Aug 25, 2021

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Placebo, and 1 other intervention for Lung Diseases, Interstitial and 2 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Interstitial, Systemic Sclerosis, Scleroderma
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 25, 2015
Enrollment StartMar 1, 2016
Primary CompletionDec 16, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.4 years ago

Interventions

Bortezomibdrug

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

Placebodrug

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

Mycophenolate mofetildrug

Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks