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โ† Trials
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A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis

RecruitingPhase 3Ages 18 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day. Participants are in the stu

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria for SSc. 3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988). 4. Disease onset (defined by first non-RP \[Raynaud's phenomenon\] symptom) must be within 7 years of Visit 1. 5. Trial participants with dcSSc must have evidence of active disease during screening. 6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative. 7. FVC % predicted โ‰ฅ45% at Visit 1. 8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted โ‰ฅ25% corrected for haemoglobin (Hb) at Visit 1. 9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. 10. Patients may be either untreated or on stable treatment with permitted immunosuppressive/immunomodulatory agents and/or nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period Exclusion criteria: 1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period. 2. Any suicidal behaviour in the past 2 years. 3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.
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What it tests

  • Placebo matching nerandomilast formulation 1
  • Placebo matching nerandomilast formulation 2
  • Nerandomilast formulation 1
  • Nerandomilast formulation 2
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Where

248 sites
University of Alabama at Birmingham
Birmingham, United States
Banner - University Medicine Rheumatology Clinic
Phoenix, United States
Arizona Arthritis and Rheumatology Associates - Paradise Valley
Scottsdale, United States
University of California Los Angeles
Los Angeles, United States
Paradigm Clinical Research - San Diego
San Diego, United States
Stanford University School of Medicine
Stanford, United States
Medvin Clinical Research-Whittier-69033
Whittier, United States
University of Colorado Denver
Aurora, United States

โ€ฆand 240 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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