A Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Sponsor: |
Merck EMD Serono |
Enrolling: |
Male and Female Patients |
Study Length: |
2 Years |
IRB Number: |
AAAQ6154 |
U.S. Govt. ID: |
NCT02745145 |
Contact: |
Rachel Broderick: 212-342-2713 / rb3173@cumc.columbia.edu |
The purpose of this study is to determine the efficacy and safety of abituzumab in subjects withsystemic sclerosis-associated interstitial lung disease (SSc-ILD).Abituzumab is an investigational drug that is being evaluated for the treatment of patients withsystemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD). Systemic sclerosis, alsoknown as scleroderma, is an autoimmune disease that can affect many organs, including the stomach,intestines, heart, and lungs. In general, SSc causes hardening of the skin and organs. SSc-ILD involves damage to lung tissue and can cause difficulty breathing and worsening lung function.Investigational means that the study drug has not been approved by any health authority (government authorities) such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and is still being tested for safety and effectiveness. Information gathered from this study will be sent to the various health authorities. The main purpose of this study is to find out if the study drug can improve the function of the lungs inpatients with SSc-ILD.
This study is closed
Investigator
Elana Bernstein, MD
Do you have systemic sclerosis / scleroderma? |
Yes |
No |
Are you taking mycophenolate (MMF or MPS)? |
Yes |
No |