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Interstitial Lung DiseasesPhase 3NCT06806592

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

A Phase 3 study testing Nerandomilast in people with Interstitial Lung Diseases and Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases, run by Boehringer Ingelheim at 153 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nerandomilast
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
414 participants
Where
153 sitesin 16 countries
Study dates
13 Sep 2025to 28 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as
  • Diagnosis by a rheumatologist (or equally qualified medical physician) 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) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
  • 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
  • No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:
  • 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: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted >5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: 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)
  • 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)
Show all 14Show fewer
  • FVC ≥45% of predicted normal at Visit 1
  • 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
  • Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:
  • If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
  • If using rituximab, participants must have completed their first cycle >6 months prior to Visit 2
  • If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
  • In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned
  • Further inclusion criteria apply

Who cannot join

  • Organising pneumonia as predominant pattern in the HRCT
  • Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 at Visit 1
  • Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
  • Active vasculitis, unstable or uncontrolled 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 Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
  • Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
  • Further exclusion criteria apply

Trial locations and contacts

153 sites in 16 countries.

153 sites in 16 countries

United States31 sites

  • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

    Atlanta, Georgia, 30309

  • Augusta University

    Augusta, Georgia, 30912

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Meris Clinical Research-Brandon-69466

    Brandon, Florida, 33511

  • Northwestern University

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • National Jewish Health

    Denver, Colorado, 80206

  • Northshore University Health System

    Evanston, Illinois, 60201

  • Northwell Health

    Great Neck, New York, 11021

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Miami VA Healthcare System

    Miami, Florida, 33125

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • NYU Langone Health

    New York, New York, 10017

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-1230

  • Temple Lung Center

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55902

  • Onsite Clinical Solutions

    Salisbury, North Carolina, 28144

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Paradigm Clinical Research - San Diego

    San Diego, California, 92108

  • Mayo Clinic-Arizona

    Scottsdale, Arizona, 85259

  • Southeastern Research Center-Winston Salem-69289

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany18 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Immanuel-Krankenhaus GmbH

    Berlin, 13125

  • Universitätsklinikum Bonn AöR

    Bonn, 53127

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • Gesundheit Nord gGmbH | Klinikverbund Bremen

    Bremen, 28325

  • Krankenhaus Porz am Rhein gGmbH

    Cologne, 51149

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Helios Fachklinik Vogelsang-Gommern GmbH

    Gommern, 39245

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

    Herne, 44649

  • medius Kliniken gGmbH

    Kirchheim unter Teck, 73230

  • Klinikum Konstanz

    Konstanz, 78464

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Klinikum der Universität München AÖR

    München, 80336

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, 93049

Other trials in Germany

China17 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Peking Union Medical College Hospital

    Beijing, 100730

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000

  • University Hospital_Macau University of Science and Technology

    Macau, 999078

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • Tianjin Medical University General Hospital

    Tianjin, 30052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

    Wuhan, 430030

  • First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Zhuzhou Central Hospital

    Zhuzhou, 412007

Other trials in China

Japan15 sites

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, Takatsuki, 569-8686

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • Juntendo University Hospital

    Tokyo, Bunkyo-Ku, 113-8431

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582

Other trials in Japan

Spain14 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Juan Ramón Jimenez

    Huelva, 21005

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Dr. Peset

    Valencia, 46017

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36312

Other trials in Spain

United Kingdom13 sites

  • Antrim Area Hospital

    Antrim, BT41 2RL

  • Royal United Hospital, Bath

    Bath, BA1 3NG

  • Heartlands Hospital

    Birmingham, B9 5SS

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Royal Free Hospital

    London, NW3 2QG

  • St George's Hospital

    London, SW17 0QT

  • University College Hospital

    London, WC1E 6BT

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • Luton & Dunstable University Hospital

    Luton, LU4 8RB

  • NIHR Lancashire Clinical Research Facility

    Preston, PR2 9HT

  • Northern General Hospital

    Sheffield, S5 7AU

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • Southend University Hospital

    Westcliffe-on-Sea, SS0 0RY

Other trials in United Kingdom

France8 sites

  • HOP d'Angers

    Angers, 49933

  • HOP Pellegrin

    Bordeaux, 33076

  • Hôpital Claude Huriez

    Lille, 59037

  • Hôpital Cochin

    Paris, 75014

  • HOP Bichat

    Paris, 75018

  • HOP Sud

    Rennes, 35203

  • HOP Civil

    Strasbourg, 67091

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31059

Other trials in France

Italy7 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • A. O. Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100

  • AOU Policlinico Umberto I

    Roma, 00161

Other trials in Italy

Mexico7 sites

  • Investigacion y Biomedicina de Chihuahua S.C.

    Chihuahua City, 31020

  • Centro Integral en Reumatologia, SA. de CV.

    Guadalajara, 44160

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Soltmed Smo

    Mexico City, 03650

  • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV

    Mexico City, 06700

  • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Switzerland6 sites

  • Cantonal Hospital of Aarau

    Aarau, CH-5001

  • Universitätsspital Basel

    Basel, 4031

  • Hopitaux Universitaires de Geneve (HUG)

    Geneva, 1205

  • Neuchatel Hospital Network

    Neuchâtel, 2000

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Australia5 sites

  • Royal Prince Alfred Hospital

    Camperdown, Sydney, New South Wales, 2050

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

Other trials in Australia

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401

Other trials in South Korea

Netherlands3 sites

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015

Other trials in Netherlands

Austria2 sites

  • Krems University Hospital

    Krems, 3500

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Norway2 sites

  • Akershus Universitetssykehus HF

    Nordbyhagen, 1478

  • Sykehuset Telemark HF, Avd. Skien

    Skien, N-3710

Other trials in Norway

Puerto Rico1 site

  • GCM Medical Group, PSC

    San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: 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)

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.

Being tested
Nerandomilast, Placebo matching nerandomilast
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NerandomilastDrug

    Also called JASCAYD®

    Nerandomilast

  • Placebo matching nerandomilastDrug

    Placebo matching nerandomilast

Study groups in NCT06806592
Study groupRoleWhat they receive
NerandomilastExperimentalParticipants with SARD-ILDs will receive nerandomilast.
Receives: Drug: Nerandomilast
PlaceboPlacebo comparatorParticipants with SARD-ILDs will receive placebo.
Receives: Drug: Placebo matching nerandomilast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26

    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.

    Quantification 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.

    A higher QILD percentage or volume indicates a higher extent of disease.

    Measured: At baseline and at Week 26

Secondary outcomes (7)

  1. Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26

    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.

    Quantification 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.

    A higher QILD percentage or volume indicates a higher extent of disease.

    Measured: At baseline and at Week 26

  2. Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26

    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.

    Quantification of HRCT scans will be performed centrally via a machine learning algorithm.

    A higher QGGO percentage or volume indicates a higher extent of disease.

    Measured: At baseline and at Week 26

  3. Absolute change from baseline in vascular volume [%] on HRCT at Week 26

    Measured: At baseline and at Week 26

  4. Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26

    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).

    Measured: At baseline and at Week 26

  5. Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline

    Measured: At baseline and at Week 52

  6. Time to first supplemental oxygen use during the trial for oxygen non-users at baseline

    Measured: Up to Week 52

  7. Occurrence of infection-related adverse events (AEs) from baseline over the duration of the trial

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start13 Sep 2025
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion28 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806592
Sponsor's protocol ID
1305-0046
Other IDs
2024-512849-17-00, U1111-1305-5857
Status last verified
Oct 2026
First submitted
28 Jan 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "time frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nerandomilast in people with Interstitial Lung Diseases and Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases, run by Boehringer Ingelheim at 153 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Germany, China, Japan, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26 (time frame: At baseline and at Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06806592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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