Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-13 @ 10:11 PM
Study NCT ID:
NCT06806592
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26', 'timeFrame': 'At baseline and at Week 26', 'description': 'QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC.\n\nQuantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD \\[%\\] is the QILD volume \\[mL\\] as a percent of the total lung volume.\n\nA higher QILD percentage or volume indicates a higher extent of disease.'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26', 'timeFrame': 'At baseline and at Week 26', 'description': 'QLF will be assessed via qHRCT. QLF are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion.\n\nQuantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD \\[%\\] is the QILD volume \\[mL\\] as a percent of the total lung volume.\n\nA higher QILD percentage or volume indicates a higher extent of disease.'}, {'measure': 'Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26', 'timeFrame': 'At baseline and at Week 26', 'description': 'QGGO will be assessed via qHRCT. QGGO are quantitative measures of different radiological patterns associated with lung fibrosis. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung.\n\nQuantification of HRCT scans will be performed centrally via a machine learning algorithm.\n\nA higher QGGO percentage or volume indicates a higher extent of disease.'}, {'measure': 'Absolute change from baseline in vascular volume [%] on HRCT at Week 26', 'timeFrame': 'At baseline and at Week 26'}, {'measure': 'Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26', 'timeFrame': 'At baseline and at Week 26', 'description': 'FVC will be assessed using standardised spirometry equipment which will be provided centrally with supplies of precalibrated disposable flow sensors. Spirometry will be conducted with the participant in a seated position. It is preferable that the same trained individual (i.e. PFT specialist or pulmonologist) performs the PFTs for a given participant. The best of 3 efforts will be defined as the highest FVC obtained on any of three blows meeting the 2019 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (with a maximum of eight attempts). Predicted normal values will be calculated according to global lung function initiative (GLI).'}, {'measure': 'Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline', 'timeFrame': 'At baseline and at Week 52'}, {'measure': 'Time to first supplemental oxygen use during the trial for oxygen non-users at baseline', 'timeFrame': 'Up to Week 52'}, {'measure': 'Occurrence of infection-related adverse events (AEs) from baseline over the duration of the trial', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Diseases', 'Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as\n\n * Diagnosis by a rheumatologist with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or Mixed connective tissue disease (MCTD)\n * Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent \\>10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review\n* No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:\n\n * No improvement in absolute forced vital capacity (FVC) % predicted \\>5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)\n * No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)\n* FVC ≥45% of predicted normal at Visit 1\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1\n* Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) with the following specifications:\n\n * If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2\n * If using rituximab, participants must have completed their first cycle \\>6 months prior to Visit 2\n* If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2\n* In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned\n* Further inclusion criteria apply\n\nExclusion Criteria :\n\n* Organising pneumonia as predominant pattern in the HRCT\n* Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) \\<0.7 at Visit 1\n* Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement\n* Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period\n* Any suicidal behaviour in the past 2 years\n* Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2\n* Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT06806592', 'briefTitle': 'A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)', 'orgStudyIdInfo': {'id': '1305-0046'}, 'secondaryIdInfos': [{'id': '2024-512849-17-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1305-5857', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerandomilast', 'description': 'Participants with SARD-ILDs will receive nerandomilast.', 'interventionNames': ['Drug: Nerandomilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants with SARD-ILDs will receive placebo.', 'interventionNames': ['Drug: Placebo matching nerandomilast']}], 'interventions': [{'name': 'Nerandomilast', 'type': 'DRUG', 'otherNames': ['JASCAYD®'], 'description': 'Nerandomilast', 'armGroupLabels': ['Nerandomilast']}, {'name': 'Placebo matching nerandomilast', 'type': 'DRUG', 'description': 'Placebo matching nerandomilast', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer 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'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Miami VA Healthcare System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 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'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Southeastern Research Center-Winston Salem-69289', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Temple Lung Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '25801', 'city': 'Beckley', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Rheumatology and Pulmonary Clinic', 'geoPoint': {'lat': 37.77817, 'lon': -81.18816}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 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