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A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc) (A study to test whether nerandomilast helps people with systemic sclerosis)

A study to test whether nerandomilast helps people with systemic sclerosis

Taguchi Aya

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamada Nobuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Pending

Aug. 01, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Patients have to be at least 18 years of age diagnosed with systemic sclerosis (diffuse cutaneous SSc [dcSSc] or limited cutaneous SSc [lcSSc]). Patients have to fulfil the following entry 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 ACR/EULAR criteria for SSc.
3) Patients must be diagnosed with lcSSc or dcSSc, as defined by LeRoy et al.
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 anticentromere antibody (ACA) negative.
7) FVC % predicted equal to or greater than 45% at Visit 1.
8) DLCO % predicted equal to or greater than 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 for a period of 28 days before treatment initiation, throughout the trial, and for a period of at least 5 days after the last dose of IMP.
WOCBP taking oral contraceptives also have to use one barrier method.
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

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

Both

systemic sclerosis

Nerandomilast/ Placebo matching nerandomilast

D012595

Time to the first occurrence of disease progression or all-cause death:
1) Adjudicated SSc-related clinically meaningful disease progression or complications*, or
2) Confirmed absolute decline from baseline in FVC % predicted eaqual to or greater than 5% (for patients with ILD at baseline)**, or
3) Relative increase from baseline in mRSS equal to or greater than 25% and absolute increase in mRSS equal to or greater than 5 points, or
4) All-cause death
*Adjudicated SSc-related clinically meaningful disease progression or complications are defined as:
Any new organ involvement or clinically meaningful worsening of an existing organ manifestation of SSc as judged by a blinded adjudication committee (AC):
a) Newly diagnosed ILD based on central evaluation of the high resolution computed tomography (HRCT; for patients without
ILD at baseline)
b) Cardiac complications:
- Haemodynamically significant cardiac disease, new onset (defined as decrease in left ventricular ejection fraction [LVEF] less than 50%) or worsening (defined as decrease in LVEF of equal to or greater than10%)
- New onset of arrhythmia requiring treatment
c) New onset of scleroderma renal crisis
d) Gastrointestinal involvement requiring hospitalisation, enteral tube feeding, or parenteral nutrition
e) Vascular complications:
- Newly diagnosed pre-capillary pulmonary hypertension (PH, Group 1 or 3) based on 2022 ERS/ESC guidelines confirmed by right heart catheterisation, or PH worsening requiring new/additional treatment, or
- Development of equal to or greater than 2 new ischemic digital ulcers (DUs) since baseline (simultaneously active at a given time point) requiring new/additional treatment or worsening of any existing DU (gangrene, amputation, or hospitalisation) requiring new/additional treatment
f) Any other SSc-related new organ involvement or clinically meaningful worsening of SSc
**[Confirmed] with respect to FVC % predicted equal to or greater than 5% means that the absolute decline from baseline is measured either (a) at 2 consecutive visits or (b) as the last available measurement before death, lost to follow-up, or withdrawal of consent/refusal to be followed up.

1) Change from baseline in mRSS at Week 52
2) Change from baseline in HAQ-DI score at Week 52
3) Change from baseline in FVC [mL] at Week 52
4) Disease improvement as defined by rCRISS-25 at Week 52
5) Time to first occurrence of confirmed absolute decline from baseline in FVC % predicted equal to or greater than 5% (for patients with ILD at baseline) ** or newly diagnosed ILD (for patients without ILD at baseline) or death
6) Time to first occurrence of absolute increase in mRSSequal to or greater than 5 points and relative increase from baseline in mRSS equal to or greater than 25% or death
7) Time to first occurrence of adjudicated SSc-related clinically meaningful disease progression or complication or death
8) Time to all-cause death
9) Change from baseline in ScleroID score at Week 52
10) Change from baseline in DU total burden at Week 52

+81-3-3822-2131

May. 29, 2026

Yes

Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

Argentina/Australia/Austria/Belgium/Brazil/Bulgaria/Canada/Chile/China/Colombia/Croatia/Czechia/Denmark/Estonia/Finland/France/Georgia/Germny/United Kingdom/Greece/Hungary/India/Israel/Italy/Korea/Lithuania/Malaysia/Mexico/Netherlands/New Zealand