Actively Recruiting
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Led by Boehringer Ingelheim · Updated on 2026-05-14
400
Participants Needed
158
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD) diagnosed by a qualified physician
- Diagnosis includes rheumatoid arthritis, systemic sclerosis (anticentromere auto-antibody negative), idiopathic inflammatory myopathy, Sjögren's disease, or mixed connective tissue disease (anti-U1-RNP auto-antibody positive)
- Presence of fibrotic interstitial lung disease on high-resolution CT scan with disease extent greater than 10%
- No improvement in lung function (forced vital capacity % predicted increase ≤5%) in the 15 months before screening based on at least two spirometry tests at least 3 months apart
- No clinically significant improvement in interstitial lung disease by clinician's judgement
- Forced vital capacity (FVC) ≥45% of predicted normal at screening
- Lung diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin within 3 months prior to or at screening
- Stable immunosuppressant treatment for at least 6 months (or 3 months for idiopathic inflammatory myopathy with ILD) before baseline
- Stable prednisone dose for at least 4 weeks prior to baseline if applicable
- Completion of rituximab cycle more than 6 months prior to baseline if applicable
- Stable nintedanib dose for at least 12 weeks prior to baseline if applicable
- No planned change in background standard of care treatment with immunosuppressants, immunomodulators, or nintedanib
You will not qualify if you...
- Organizing pneumonia as predominant pattern on HRCT
- Prebronchodilator FEV1/FVC ratio less than 0.7 at screening
- Acute interstitial lung disease exacerbation within 3 months prior to screening or during screening period
- Active vasculitis unstable or uncontrolled within 8 weeks prior to screening or during screening period
- Any suicidal behavior in the past 2 years
- Suicidal ideation of type 4 or 5 on Columbia-Suicide Severity Rating Scale in past 3 months or at screening
- Use of cyclophosphamide within 6 months prior to screening
- Use of pirfenidone within 8 weeks prior to screening
- Additional exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 158 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic-Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
Paradigm Clinical Research - San Diego
San Diego, California, United States, 92108
Actively Recruiting
5
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
6
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Meris Clinical Research-Brandon-69466
Brandon, Florida, United States, 33511
Not Yet Recruiting
8
Miami VA Healthcare System
Miami, Florida, United States, 33125
Actively Recruiting
9
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, United States, 30309
Actively Recruiting
10
Augusta University
Augusta, Georgia, United States, 30912
Not Yet Recruiting
11
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
12
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
13
Northshore University Health System
Evanston, Illinois, United States, 60201
Actively Recruiting
14
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
15
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
17
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
18
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
19
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55902
Actively Recruiting
20
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1230
Actively Recruiting
21
Northwell Health
Great Neck, New York, United States, 11021
Not Yet Recruiting
22
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
23
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States, 10024
Not Yet Recruiting
24
Onsite Clinical Solutions
Salisbury, North Carolina, United States, 28144
Actively Recruiting
25
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
26
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
27
Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
28
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
29
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
30
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
31
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
32
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States, 25801
Actively Recruiting
33
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
34
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, Australia, 2050
Actively Recruiting
35
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Not Yet Recruiting
36
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Actively Recruiting
37
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
38
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
39
Krems University Hospital
Krems, Austria, 3500
Actively Recruiting
40
AKH - Medical University of Vienna
Vienna, Austria, 1090
Not Yet Recruiting
41
Klinikum Wels - Grieskirchen GmbH
Wels, Austria, 4600
Actively Recruiting
42
Beijing Chao-Yang Hospital
Beijing, China, 100020
Actively Recruiting
43
China-Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
44
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
45
West China Hospital, Sichuan University
Chengdu, China, 610041
Not Yet Recruiting
46
People's Hospital of Sichuan Province
Chengdu, China, 610072
Actively Recruiting
47
Guangdong Provincial People's Hospital
Guangzhou, China, 510080
Actively Recruiting
48
The First Affiliated Hospital, Zhejiang University
Hangzhou, China, 310003
Actively Recruiting
49
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
50
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China, 471000
Actively Recruiting
51
University Hospital_Macau University of Science and Technology
Macau, China, 999078
Not Yet Recruiting
52
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Not Yet Recruiting
53
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
54
Tianjin Medical University General Hospital
Tianjin, China, 30052
Actively Recruiting
55
Wuhan Union Hospital
Wuhan, China, 430022
Not Yet Recruiting
56
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, China, 430030
Actively Recruiting
57
First Affiliated Hospital of Xiamen University
Xiamen, China, 361003
Not Yet Recruiting
58
Zhuzhou Central Hospital
Zhuzhou, China, 412007
Actively Recruiting
59
HOP d'Angers
Angers, France, 49933
Actively Recruiting
60
HOP Pellegrin
Bordeaux, France, 33076
Actively Recruiting
61
Hôpital Claude Huriez
Lille, France, 59037
Not Yet Recruiting
62
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
63
HOP Bichat
Paris, France, 75018
Not Yet Recruiting
64
HOP Sud
Rennes, France, 35203
Not Yet Recruiting
65
HOP Civil
Strasbourg, France, 67091
Not Yet Recruiting
66
Hôpital Rangueil - CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
67
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Not Yet Recruiting
68
Immanuel-Krankenhaus GmbH
Berlin, Germany, 13125
Actively Recruiting
69
Universitätsklinikum Bonn AöR
Bonn, Germany, 53127
Actively Recruiting
70
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany, 38126
Not Yet Recruiting
71
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, Germany, 28325
Completed
72
Krankenhaus Porz am Rhein gGmbH
Cologne, Germany, 51149
Not Yet Recruiting
73
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Not Yet Recruiting
74
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
75
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45239
Actively Recruiting
76
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
77
Helios Fachklinik Vogelsang-Gommern GmbH
Gommern, Germany, 39245
Not Yet Recruiting
78
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
79
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Herne, Germany, 44649
Not Yet Recruiting
80
medius Kliniken gGmbH
Kirchheim unter Teck, Germany, 73230
Actively Recruiting
81
Klinikum Konstanz
Konstanz, Germany, 78464
Actively Recruiting
82
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Actively Recruiting
83
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Not Yet Recruiting
84
Klinikum der Universität München AÖR
München, Germany, 80336
Not Yet Recruiting
85
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany, 93049
Not Yet Recruiting
86
ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
87
A. O. Universitaria Careggi
Florence, Italy, 50134
Not Yet Recruiting
88
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
89
Ospedale San Raffaele S.r.l.
Milan, Italy, 20132
Not Yet Recruiting
90
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, 41124
Not Yet Recruiting
91
Azienda Ospedaliera Universitaria di Padova
Padova, Italy, 35128
Not Yet Recruiting
92
Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Actively Recruiting
93
AOU Policlinico Umberto I
Roma, Italy, 00161
Not Yet Recruiting
94
Fujita Health University Hospital
Aichi, Toyoake, Japan, 470-1192
Not Yet Recruiting
95
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan, 807-8556
Actively Recruiting
96
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
97
Sapporo Medical University Hospital
Hokkaido, Sapporo, Japan, 060-8543
Not Yet Recruiting
98
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Actively Recruiting
99
Kagawa University Hospital
Kagawa, Kita-gun, Japan, 761-0793
Completed
100
St. Marianna University Hospital
Kanagawa, Kawasaki, Japan, 216-8511
Not Yet Recruiting
101
Kitasato University Hospital
Kanagawa, Sagamihara, Japan, 252-0375
Actively Recruiting
102
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
Actively Recruiting
103
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan, 852-8501
Not Yet Recruiting
104
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, Japan, 569-8686
Not Yet Recruiting
105
Saitama Medical University Hospital
Saitama, Iruma-gun, Japan, 350-0495
Actively Recruiting
106
Juntendo University Hospital
Tokyo, Bunkyo-Ku, Japan, 113-8431
Actively Recruiting
107
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, Japan, 113-8603
Actively Recruiting
108
Keio University Hospital
Tokyo, Shinjuku-ku, Japan, 160-8582
Actively Recruiting
109
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, Mexico, 31020
Actively Recruiting
110
Centro Integral en Reumatologia, SA. de CV.
Guadalajara, Mexico, 44160
Actively Recruiting
111
Soltmed Smo
Mexico City, Mexico, 03650
Actively Recruiting
112
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, Mexico, 06700
Not Yet Recruiting
113
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Not Yet Recruiting
114
Medical Care & Research SA de CV
Mérida, Mexico, 97070
Actively Recruiting
115
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Mexico, 64460
Actively Recruiting
116
Zuyderland Medisch Centrum
Heerlen, Netherlands, 6419 PC
Actively Recruiting
117
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Not Yet Recruiting
118
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, Netherlands, 3015
Not Yet Recruiting
119
Akershus Universitetssykehus HF
Nordbyhagen, Norway, 1478
Not Yet Recruiting
120
Sykehuset Telemark HF, Avd. Skien
Skien, Norway, N-3710
Not Yet Recruiting
121
GCM Medical Group, PSC
San Juan, Puerto Rico, 00917
Not Yet Recruiting
122
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
123
Kyung Hee University Hospital
Seoul, South Korea, 02447
Actively Recruiting
124
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
125
Soonchunhyang University Hospital Seoul
Seoul, South Korea, 04401
Actively Recruiting
126
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08026
Actively Recruiting
127
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
128
Hospital de Basurto
Bilbao, Spain, 48013
Actively Recruiting
129
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Actively Recruiting
130
Hospital Juan Ramón Jimenez
Huelva, Spain, 21005
Actively Recruiting
131
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
132
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
133
Fundación Jiménez Díaz
Madrid, Spain, 28040
Not Yet Recruiting
134
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
135
Hospital Clínico de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
136
Hospital Universitario Virgen De La Macarena
Seville, Spain, 41009
Actively Recruiting
137
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
138
Hospital Dr. Peset
Valencia, Spain, 46017
Actively Recruiting
139
Complejo Hospitalario Universitario de Vigo
Vigo, Spain, 36312
Actively Recruiting
140
Cantonal Hospital of Aarau
Aarau, Switzerland, CH-5001
Actively Recruiting
141
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
142
Hopitaux Universitaires de Geneve (HUG)
Geneva, Switzerland, 1205
Not Yet Recruiting
143
Neuchatel Hospital Network
Neuchâtel, Switzerland, 2000
Actively Recruiting
144
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
145
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
146
Antrim Area Hospital
Antrim, United Kingdom, BT41 2RL
Actively Recruiting
147
Royal United Hospital, Bath
Bath, United Kingdom, BA1 3NG
Not Yet Recruiting
148
Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
149
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
150
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
151
St George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
152
University College Hospital
London, United Kingdom, WC1E 6BT
Actively Recruiting
153
Altnagelvin Area Hospital
Londonderry, United Kingdom, BT47 6SB
Actively Recruiting
154
Luton & Dunstable University Hospital
Luton, United Kingdom, LU4 8RB
Actively Recruiting
155
NIHR Lancashire Clinical Research Facility
Preston, United Kingdom, PR2 9HT
Not Yet Recruiting
156
Northern General Hospital
Sheffield, United Kingdom, S5 7AU
Actively Recruiting
157
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
158
Southend University Hospital
Westcliffe-on-Sea, United Kingdom, SS0 0RY
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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