Nerandomilast for Systemic Sclerosis in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial will randomly assign adults with limited or diffuse cutaneous systemic sclerosis to receive nerandomilast or a matching placebo, taken twice daily. The goal is to see if nerandomilast improves symptoms and slows disease progression while assessing tolerability. Participants will be followed for approximately 1 to 4 years with regular site visits and phone check-ins. Eligibility includes age 18 or older, confirmed systemic sclerosis, active disease, and adequate lung function at screening.

Why it matters

Who can join: the full rules

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 ≥45% at Visit 1.
8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% 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.

Where it's running

• Paradigm Clinical Research - San Diego
  San Diego, California, United States Recruiting
• Medvin Clinical Research-Whittier-69033
  Whittier, California, United States Recruiting
• Millennium Research - Ormond Beach
  Ormond Beach, Florida, United States Recruiting
• BioResearch Partner - South Miami
  South Miami, Florida, United States Recruiting
• DelRicht Research-New Orleans-64100
  New Orleans, Louisiana, United States Recruiting
• Clinical Research Institute of Michigan, LLC - St. Clair Shores
  Saint Clair Shores, Michigan, United States Recruiting

+198 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.