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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04837131 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
W. Leroy Griffing |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Leroy Griffing, MD |
Principal Investigator Affiliation | Mayo Clinic |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
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 |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.