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Taking peoplePhase 3

Testing nerandomilast tablets against placebo in adults with systemic sclerosis

Tests nerandomilast against placebo tablets in adults with systemic sclerosis.

Key facts

Who runs it
Boehringer Ingelheim
Where
Haifa, Kfar Saba, and Ramat Gan, IsraelSee the 4 sitesAlso in 44 other countries, 244 sites
Trial code
Registry title
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Status
Recruiting
Phase
Phase 3
People taking part
448 people, planned
Started
27 Jul 2026
Expected to end
17 Mar 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo matching nerandomilast formulation 1
  • Placebo matching nerandomilast formulation 2
  • Nerandomilast formulation 1
  • Nerandomilast formulation 2
Record updated
14 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with systemic sclerosis (limited or diffuse cutaneous) whose disease began within the last 7 years. It tests whether nerandomilast helps compared with placebo.

Age
18 years or older
Sex
All sexes can join
Disease stage
Limited or diffuse cutaneous systemic sclerosis, with disease onset (first symptom other than Raynaud's) within 7 years of Visit 1, and signs of active disease during screening
Earlier treatment
People can be untreated, or on stable treatment with allowed immunosuppressive or immunomodulatory medicines and/or nintedanib. Treatment must stay stable before Visit 2 and during screening.
Biomarker or test result
People with limited cutaneous SSc must be anti-centromere antibody (ACA) negative. Lung tests at Visit 1: FVC % predicted 45% or higher and DLCO % predicted 25% or higher (corrected for haemoglobin).

Main reasons for not taking part

  • Active, unstable or uncontrolled vasculitis within 8 weeks before Visit 1 or during screening
  • Any suicidal behaviour in the past 2 years
  • Suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months
  • Women who could become pregnant and cannot use highly effective birth control

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • 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
  • Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988)
  • Disease onset (defined by first non-RP [Raynaud's phenomenon] symptom) must be within 7 years of Visit 1
  • Trial participants with dcSSc must have evidence of active disease during screening
  • Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative
  • FVC % predicted ≥45% at Visit 1
  • Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1
  • Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control
  • 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

Who cannot take part

  • Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period
  • Any suicidal behaviour in the past 2 years
  • Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply

Where in Israel

Also in 44 other countries, 244 sites

  • Bnai Zion Medical Center, HaifaHaifa, IsraelContact: Boehringer IngelheimNot yet recruiting
  • Rambam Health Care CampusHaifa, IsraelContact: Boehringer IngelheimNot yet recruiting
  • Meir Medical CenterKfar Saba, IsraelContact: Boehringer IngelheimNot yet recruiting
  • Sheba MCRamat Gan, IsraelContact: Boehringer IngelheimNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    Treatment: Placebo matching nerandomilast formulation 1 and Placebo matching nerandomilast formulation 2

  • NerandomilastTreatment being tested

    Treatment: Nerandomilast formulation 1 and Nerandomilast formulation 2

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
Plain-language title
Testing nerandomilast tablets against placebo in adults with systemic sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Publications
Record updated
14 October 2026