A Phase 3 interventional study of Placebo matching nerandomilast formulation 1 and Placebo matching nerandomilast formulation 2 in Systemic Sclerosis, sponsored by Boehringer Ingelheim. Recruiting at 248 sites in 45 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 448 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo matching nerandomilast formulation 1 · Drug: Placebo matching nerandomilast formulation 2
Drug: Nerandomilast formulation 1 · Drug: Nerandomilast formulation 2
Film-coated tablets
Film-coated tablets
Film-coated tablets
Film-coated tablets
Time to the first occurrence of disease progression or all-cause death
Time frame: up to 4 years
Change from baseline in mRSS at Week 52
The modified Rodnan Skin Score (mRSS) measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). The total mRSS ranges from 0 (best possible outcome) to 51 (worst possible outcome).
Time frame: At baseline and at Week 52.
Change from baseline in HAQ-DI score at Week 52
Health Assessment Questionnaire Disability Index (HAQ-DI) is used frequently in rheumatological disorders including SSc, assessing function/activities of daily living with 20 items in 8 categories, namely dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Each category has at least 2 sub-category questions. Within each category, patients report the amount of difficulty they have in performing the specific sub-category items. There are four response options ranging from "no difficulty" to "unable to do", scored 0 to 3. A global score will be calculated from the category scores with higher scores indicating more severe disability.
Time frame: At baseline and at Week 52.
Change from baseline in FVC [mL] at Week 52
Forced vital capacity (FVC)
Time frame: At baseline and at Week 52.
Disease improvement as defined by rCRISS-25 at Week 52
Revised composite response index in systemic sclerosis (rCRISS) is a composite outcome measure developed for SSc that includes PRO and clinician-reported outcome (ClinRO) measures: * mRSS * FVC % * HAQ-DI * Patient Global Assessment (PGA) of overall health status * Clinician Global Assessment (CGA) of overall health status For rCRISS-25 a patient has improvement on at least 2 of the 5 core set measures and without worsening on more than 1 core set measure. The improvement or worsening must be at least 25% relative change from the baseline for 4 core set measures (or ≥5% relative change from baseline for FVC % predicted).
Time frame: At baseline and at Week 52.
Time to first occurrence of confirmed absolute decline from baseline in FVC % predicted ≥5% (for patients with ILD at baseline) or newly diagnosed ILD (for patients without ILD at baseline) or death
Time frame: up to 4 years
Time to first occurrence of absolute increase in mRSS ≥5 points and relative increase from baseline in mRSS ≥25% or death
Time frame: up to 4 years
Time to first occurrence of adjudicated SSc-related related clinically meaningful disease progression or complication or death
Time frame: up to 4 years
Time to all-cause death
Time frame: up to 4 years
Change from baseline in Systemic Sclerosis Impact of Disease (ScleroID) score at Week 52
The Systemic Sclerosis Impact of Disease (ScleroID) is a patient reported outcome (PRO) measure specifically developed to assess how SSc affects a person's life. The ScleroID has 10 items and it covers 10 domains. Every item is rated on a 0-10 numeric rating scale and the individual scores are computed using a weighted sum, resulting in a final score ranging from 0 to 10. A higher score means a higher impact of disease.
Time frame: At baseline and at Week 52.
Change from baseline in digital ulcer total burden at Week 52
Time frame: At baseline and at Week 52.
Showing the first 100 of 248 sites across 45 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Started Jul 2026 (actual). Primary completion is estimated for Feb 2030, 42 months after the start.
Of 17 phase 3 interventional studies under Scleroderma, Systemic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 36. This study's planned 42 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.