Testing nerandomilast tablets against placebo in adults with systemic sclerosis
Tests nerandomilast against placebo tablets in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Key facts
- Where
- Solna, SwedenSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Where in Sweden
- Karolinska University HospitalSolna, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07497087EU 2025-523884-39-00
- Record updated
- 14 October 2026
- Original description
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
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
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 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.
Inclusion: 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.
Exclusion: 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.