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A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients

Systemic Sclerosis Clinical Trial

Official title:
A Phase 2 Open-Label Pilot Study of the Safety and Tolerability of Ixazomib Administered Orally to Patients With Scleroderma-Related Interstitial Lung Disease

Clinical Trial Summary

The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.

Clinical Trial Description

The primary objective of this study is to assess the safety and tolerability of oral ixazomib taken on days 1, 8, and 15 of each 28-day treatment cycle for 6 cycles in 12 participants having diffuse systemic sclerosis/scleroderma of less than 5 years duration with non-severe interstitial lung involvement as identified from chest CT scan completed within the preceding 3 months or at study screening visit. All 12 participants will receive oral ixazomib. Reflecting the common use of mycophenolate in the management of scleroderma with complicating interstitial lung disease, 6 of 12 participants who will be enrolled will be already taking mycophenolate at a stable dose for the preceding 3 months and will be allowed to continue taking mycophenolate throughout the entire study prescribed as routine care. Ixazomib will be added to their medications. The remaining 6 of 12 participants meeting the same eligibility criteria will not be using mycophenolate or any other treatment for scleroderma interstitial lung disease at the time of enrollment and will subsequently take ixazomib study medication during participation in this study. Ixazomib dose modification or interruption is allowed for safety and tolerability reasons at any time during the study. The secondary objective of this study is to assess the effect of ixazomib on scleroderma skin tightness/thickening and its effect on scleroderma interstitial lung disease. The study includes approximately 13 clinic visits over up to approximately 10 months. Study procedures include medical examinations, blood tests, chest CT scans, pulmonary function tests, echocardiogram, EKG, skin biopsies, and questionnaires. There is no cost for participation in this study. ;

Study Design

Related Conditions & MeSH terms

  • Diffuse Cutaneous Scleroderma
  • Diffuse Cutaneous Systemic Sclerosis
  • Diffuse Scleroderma
  • Diffuse Systemic Sclerosis
  • Interstitial Lung Disease
  • Lung Diseases
  • Lung Diseases, Interstitial
  • Progressive Scleroderma
  • Progressive Systemic Sclerosis
  • Pulmonary Fibrosis
  • Pulmonary Fibrosis Interstitial
  • Scleroderma
  • Scleroderma of Lung
  • Scleroderma With Pulmonary Involvement
  • Scleroderma, Diffuse
  • Scleroderma, Localized
  • Scleroderma, Systemic
  • Scleroderma;Progressive
  • Sclerosis
  • Systemic Sclerosis
  • Systemic Sclerosis Pulmonary
  • Systemic Sclerosis With Lung Involvement
  • Systemic Sclerosis, Diffuse
  • Systemic; Sclerosis, Progressive
Clinical Trial Details
NCT number NCT04837131
Study type Interventional
Source Mayo Clinic
Contact
Status Terminated
Phase Phase 2
Start date April 28, 2021
Completion date February 23, 2024
View Details
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