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A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

StatusRecruiting
PhasePhase 3
Started2025-09-13
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
Study Status, Contacts/Locations v42
Study sitesdetails revised at 1 of 154 sites
2026-08-19
Study Status, Contacts/Locations v41
Study sites156→154
2026-08-05
Study Status, Contacts/Locations v40
Study sites156 entries, revised
Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology
2026-07-22
Study Status, Contacts/Locations v39
Study sites158→156
2026-07-08
Study Status, Contacts/Locations v38
Study sitesdetails revised at 5 of 158 sites
Show 37 earlier versions
2026-06-23
Study Status, Contacts/Locations v37
Study sitesdetails revised at 6 of 158 sites
2026-06-09
Study Status, Contacts/Locations v36
Study sitesdetails revised at 9 of 158 sites
2026-05-28
Study Status, Contacts/Locations v35
Study sitesdetails revised at 4 of 158 sites
2026-05-13
Study Status, Contacts/Locations v34
Study sitesdetails revised at 4 of 158 sites
2026-04-28
Study Status, Contacts/Locations v33
Study sitesdetails revised at 6 of 158 sites
2026-04-21
Study Status, Contacts/Locations v32
Study sitesdetails revised at 9 of 158 sites
2026-04-13
Study Status, Eligibility, Contacts/Locations v31
Eligibility criteria+363 characters
[...] iseases (SARD-ILD), defined as Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthriti [...] iopathic inflammatory myopathy (IIM), Sjögren's disease, or Mixedmixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive) Presence of fibrotic interstitial lung disease (ILD) on hig [...] 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted [...] [...]
Study sitesdetails revised at 6 of 158 sites
2026-03-26
Study Status, Contacts/Locations v30
Study sites158 entries, revised
Hospital Universitari Vall D d'Hebron
2026-03-18
Study Status, Contacts/Locations v29
Study sites158 entries, revised
The University of Chicago Medical Center St George's Hospital-London-26733
2026-03-02
Study Status, Contacts/Locations v28
Study sitesdetails revised at 4 of 158 sites
2026-02-19
Study Status, Contacts/Locations v27
Study sitesdetails revised at 4 of 158 sites
2026-02-17
Study Status, Contacts/Locations v26
Study sites157→158
2026-02-03
Study Status, Contacts/Locations, IPDSharing, References v25
Study sites157 entries, revised
West China Hospital of, Sichuan University HOPHôpital Rangueil - CHU de Toulouse
2026-01-20
Study Status, Contacts/Locations v24
Study sitesdetails revised at 11 of 157 sites
2026-01-08
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 157 sites
2026-01-07
Study Status, Contacts/Locations v22
Study sites157 entries, revised
Mayo Clinic, Rochester St. Antonius ziekenhuis, locatie NieuwegeinZiekenhuis
2025-12-18
Study Status, Contacts/Locations v21
Study sites157 entries, revised
UniversitàAzienda degliOspedaliera StudiUniversitaria di Padova
2025-12-11
Study Status, Contacts/Locations v20
Study sitescontacts updated at 15 of 157 sites
2025-12-10
Study Status, Contacts/Locations v19
Study sites157 entries, revised
Azienda Ospedaliera PoliclinicoOspedaliero-Universitaria di Modena
2025-11-25
Study Status, Contacts/Locations v18
Study sites157 entries, revised
HOPHôpital Claude Huriez ChariteCharité - Universitätsmedizin Berlin KöR
2025-11-11
Study Status, Contacts/Locations v17
Study sites157 entries, revised
Piedmont HospitalPhysicians Pulmonary & Sleep Medicine of Buckhead HOPHôpital Cochin IRCCSOspedale San Raffaele S.r.l. Hospital Universitario Reina Sofía-Córdoba-40500
2025-10-28
Study Status, Contacts/Locations v16
Study sites156→157
2025-10-15
Study Status, Arms and Interventions, Contacts/Locations v15
Study sites153→156
2025-09-29
Study Status, Contacts/Locations v14
Study sites154→153
2025-09-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v13
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-12→confirmed 2025-09-13
Study sitesdetails revised at 154 of 154 sites
2025-09-16
Study Status v12
Re-verified, no change to tracked fields
2025-09-05
Study Status, Contacts/Locations v11
Start date2025-08-21→2025-09-12
Study sites155→154
2025-07-21
Study Status, Contacts/Locations v10
Study sites153→155
2025-06-27
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v9
Eligibility criteria+9 characters
[...] es (SARD-ILD), defined as Diagnosis by a rheumatologist with at least 1 of the following SARDs: Rheumatoid arthritis (RA), system [...]
Secondary endpoints6 to 7 entries
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26 Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] aton Week 26 Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Dyspnoea domain scoreHRCT at Week 26 Absolute change from baseline in livingvascular withvolume pulmonary[%] fibrosison (L-PF) Symptoms Cough domain scoreHRCT at Week 26 Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline Time to first supplemental oxygen use during the tr [...] [...]
Primary endpoints1 entry, revised
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26.
2025-06-11
Study Status, Contacts/Locations v8
Start date2025-07-10→2025-08-21
Study sites152→153
2025-05-27
Study Status, Contacts/Locations v7
Study sites139→152
2025-04-28
Study Status v6
Primary completion date2027-03-17→2027-07-17
Completion date2027-03-31→2027-07-30
2025-04-14
Study Status, Contacts/Locations v5
Study sites140→139
2025-03-12
Study Status, Contacts/Locations v4
Start date2025-03-10→2025-07-10
Study sitescontacts updated at 1 of 140 sites
2025-03-03
Study Status, Contacts/Locations v3
Study sites139→140
2025-02-17
Study Status, Contacts/Locations v2
Study sites137→139
2025-02-04
Study Status, Conditions, Contacts/Locations v1
Study sites134→137
2025-01-28
Original filing
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. 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 a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT06806592
Lead Sponsor Boehringer Ingelheim
Conditions Interstitial Lung Diseases, Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
Enrollment 400 participants
Start Date 2025-09-13
Primary Completion 2027-07-17 (estimated)
Study Completion 2027-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-16