A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo matching nerandomilast formulation 1, Placebo matching nerandomilast formulation 2, Nerandomilast formulation 1, Nerandomilast formulation 2.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +40
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
Overview
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.
Interventions
- Drug Placebo matching nerandomilast formulation 1
Film-coated tablets - Drug Placebo matching nerandomilast formulation 2
Film-coated tablets - Drug Nerandomilast formulation 1
Film-coated tablets - Drug Nerandomilast formulation 2
Film-coated tablets
Primary outcome measures
- Time to the first occurrence of disease progression or all-cause death [Time frame: up to 4 years]
Secondary outcome measures (10)
- Change from baseline in mRSS at Week 52 [Time frame: At baseline and at Week 52.]
- Change from baseline in HAQ-DI score at Week 52 [Time frame: At baseline and at Week 52.]
- Change from baseline in FVC [mL] at Week 52 [Time frame: At baseline and at Week 52.]
- Disease improvement as defined by rCRISS-25 at Week 52 [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 [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.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 30 centers
- University of Alabama at Birmingham — Birmingham
- Banner - University Medicine Rheumatology Clinic — Phoenix
- Arizona Arthritis and Rheumatology Associates - Paradise Valley — Scottsdale
- University of California Los Angeles — Los Angeles
- Paradigm Clinical Research - San Diego — San Diego
- Stanford University School of Medicine — Stanford
- Medvin Clinical Research-Whittier-69033 — Whittier
- University of Colorado Denver — Aurora
- … and 22 more centers
China · 25 centers
- China-Japan Friendship Hospital — Beijing
- Peking University First Hospital — Beijing
- Peking Union Medical College Hospital — Beijing
- The First Hospital of Jilin University — Changchun
- Xiangya Hospital, Central South University — Changsha
- The Second Xiangya Hospital Of Central South University — Changsha
- West China Hospital, Sichuan University — Chengdu
- Guangdong Provincial People's Hospital — Guangzhou
- … and 17 more centers
Japan · 20 centers
Center list to be confirmed — check the primary protocol.
Germany · 11 centers
Center list to be confirmed — check the primary protocol.
Spain · 11 centers
Center list to be confirmed — check the primary protocol.
France · 10 centers
Center list to be confirmed — check the primary protocol.
Italy · 8 centers
Center list to be confirmed — check the primary protocol.
Mexico · 8 centers
Center list to be confirmed — check the primary protocol.
India · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Centro Medico Reumatologico - OMI — CABA
- Mautalen- Salud e Investigacion — CABA
- Instituto de Investigación Clínica TyT — CABA
- Sanatorio Maipú — Maipu
- Instituto de Investigaciones Clínicas de Quilmes — Quilmes
- Sanatorio de la Mujer — Rosario
Belgium · 6 centers
- Hopital Erasme — Brussels
- Universitair Ziekenhuis Gent — Ghent
- Universitair Ziekenhuis Brussel — Jette
- UZ Leuven — Leuven
- Centre Hospitalier Universitaire de Liège — Liège
- CHU UCL Namur — Yvoir
Brazil · 6 centers
- SAPIENS - Instituto de Estudos e Pesquisa Clínica — Curitiba
- Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
- Hospital das Clínicas da Universidade Federal de Pernambuco — Recife
- Hospital Mater Dei BA — Salvador
- Fundacao Oswaldo Ramos (Hospital do Rim) — São Paulo
- Azidus Centro de Pesquisa Clinica Avancada — Valinhos
Portugal · 6 centers
Center list to be confirmed — check the primary protocol.
Norway · 5 centers
Center list to be confirmed — check the primary protocol.
Poland · 5 centers
Center list to be confirmed — check the primary protocol.
Colombia · 4 centers
Center list to be confirmed — check the primary protocol.
Georgia · 4 centers
Center list to be confirmed — check the primary protocol.
Romania · 4 centers
Center list to be confirmed — check the primary protocol.
South Korea · 4 centers
Center list to be confirmed — check the primary protocol.
Thailand · 4 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Bulgaria · 3 centers
- Military medical academy - MHAT Pleven — Pleven
- UMHAT Pulmed OOD — Plovdiv
- Diagnostic Consultative Center Alexandrovska — Sofia
Canada · 3 centers
- CaRe Clinic (Calgary) — Calgary
- University of Alberta Hospital (University of Alberta) — Edmonton
- St. Joseph's Health Care (London, Ontario) — London
Croatia · 3 centers
Center list to be confirmed — check the primary protocol.
Estonia · 3 centers
Center list to be confirmed — check the primary protocol.
Finland · 3 centers
Center list to be confirmed — check the primary protocol.
Greece · 3 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 3 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Philippines · 3 centers
Center list to be confirmed — check the primary protocol.
Australia · 2 centers
- Royal Adelaide Hospital — Adelaide
- St Vincent's Hospital Melbourne — Fitzroy
Austria · 2 centers
- Medizinische Universitaet Innsbruck — Innsbruck
- Ordensklinikum Linz GmbH — Linz
Chile · 2 centers
- Centro Internacional de Estudios Clínicos (CIEC) — Comuna de Recoleta
- Ctr Estudios — Providencia
Czechia · 2 centers
Center list to be confirmed — check the primary protocol.
Denmark · 2 centers
Center list to be confirmed — check the primary protocol.
Hungary · 2 centers
Center list to be confirmed — check the primary protocol.
Israel · 2 centers
Center list to be confirmed — check the primary protocol.
Lithuania · 2 centers
Center list to be confirmed — check the primary protocol.
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 2 centers
Center list to be confirmed — check the primary protocol.
Vietnam · 2 centers
Center list to be confirmed — check the primary protocol.
South Africa · 1 center
Center list to be confirmed — check the primary protocol.
Sweden · 1 center
Center list to be confirmed — check the primary protocol.
Switzerland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07497087 · 1305-0052 · 2025-523884-39-00 · U1111-1329-6365