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A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

Status: Recruiting

Nerandomilast is being developed to treat lung fibrosis. This study is to test a drug called nerandomilast in people with SARD-ILD who also take an immunosuppressant medicine. Participants are put into 2 groups randomly, which means by chance and will receive either nerandomilast or placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any study drug. Participants will be in the study for about 7.5 to 13 months depending on when they join the study.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD)
• lung function has not improved with immunosuppressant (IS) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active vasculitis
• suicidal behavior in the past 2 years
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:

Rare Diseases, Rare Diseases, Respiratory System

Keywords:

Clinics and Surgery Center (CSC), Autoimmune Rheumatic Diseases, Interstitial Lung Diseases

Study Contact: Mandi DeGrote - carl1032@umn.edu
Principal Investigator: Hyun Kim
Phase: PHASE3
IRB Number: STUDY00024424
See this study on ClinicalTrials.gov

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