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

NCT04837131 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-04-06

Study results available
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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.

Conditions

  • Systemic Sclerosis
  • Scleroderma
  • Diffuse Systemic Sclerosis
  • Diffuse Scleroderma
  • Diffuse Cutaneous Systemic Sclerosis
  • Diffuse Cutaneous Scleroderma
  • Progressive Systemic Sclerosis
  • Progressive Scleroderma
  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Scleroderma;Progressive
  • Systemic Sclerosis, Diffuse
  • Systemic; Sclerosis, Progressive
  • Scleroderma of Lung
  • Scleroderma With Pulmonary Involvement
  • Systemic Sclerosis Pulmonary
  • Systemic Sclerosis With Lung Involvement
  • Interstitial Lung Disease
  • Pulmonary Fibrosis Interstitial

Interventions

DRUG

Ixazomib

Ixazomib 4 mg capsule taken orally on days 1, 8, and 15 of a 28-day treatment cycle repeated for 6 cycles

Sponsors & Collaborators

  • Michael M. Pham

    lead OTHER

Principal Investigators

  • Michael Pham, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2024-02-23
Completion
2024-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04837131 on ClinicalTrials.gov