RECRUITING Phase 2 ClinicalTrials.gov

Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07230288

Registry updated: 2026-09-03

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Description

Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1). ABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is "double-blind", meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world. Participants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventions

ABBV-142 (Drug)
ABBV-142
Placebo for ABBV-142 (Drug)
Placebo for ABBV-142

Eligibility criteria

Inclusion Criteria: \- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP. Exclusion Criteria: * History of stroke within 6 months prior to screening * In the opinion of the investigator, other clinically significant pulmonary abnormalities * History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.

Conditions

Idiopathic Pulmonary Fibrosis

Locations

The University of Alabama at Birmingham /ID# 277613 — Birmingham, Alabama, United States
Sec Clinical Research - East - Dothan - Graceland /ID# 278328 — Dothan, Alabama, United States
Clinical Research Specialists - Kissimmee /ID# 279184 — Kissimmee, Florida, United States
Christie Clinic on University /ID# 277871 — Champaign, Illinois, United States
University of Michigan Health System - Ann Arbor /ID# 279994 — Ann Arbor, Michigan, United States
Henry Ford Hospital /ID# 277843 — Detroit, Michigan, United States
Hannibal Regional Hospital /ID# 277984 — Hannibal, Missouri, United States
Jefferson Health Honickman Center /ID# 279127 — Philadelphia, Pennsylvania, United States
Inova Fairfax Hospital /ID# 278469 — Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center /ID# 277992 — Richmond, Virginia, United States
Lung Research Queensland /ID# 278838 — Nundah, Queensland, Australia
Eastern Health /ID# 278245 — Box Hill, Victoria, Australia
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845 — Pleven, Bulgaria
University Multiprofile Hospital For Active Treatment Sveti Georgi - Plovdiv /ID# 279367 — Plovdiv, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846 — Sofia, Bulgaria
Diagnostic Consultative Center Convex /ID# 277848 — Sofia, Bulgaria
Diagnostic Consultative Center Convex /ID# 277849 — Sofia, Bulgaria
Centre d'Investigation Clinique Mauricie /ID# 277949 — Trois-Rivières, Quebec, Canada
Hopital Arnaud de Villeneuve /ID# 278322 — Montpellier, Herault, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 278333 — Rennes, Ille-et-Vilaine, France
Hopital Avicenne /ID# 279212 — Bobigny, Île-de-France Region, France
Klinikum Konstanz /ID# 278139 — Konstanz, Baden-Wurttemberg, Germany
Caritas-Krankenhaus St. Maria gGmbH /ID# 278138 — Donaustauf, Bavaria, Germany
University General Hospital of Patras /ID# 277726 — Pátrai, Achaia, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724 — Athens, Attica, Greece
University General Hospital of Heraklion /ID# 277717 — Heraklion, Crete, Greece
University Hospital of Ioannina /ID# 277719 — Ioannina, Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 277819 — Thessaloniki, Greece
NHO Kinki Chuo Chest Medical Center /ID# 280225 — Sakai-shi, Osaka, Japan
Vitamed Galaj i Cichomski Sp.j. /ID# 278145 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Unidade Local de Saude de Loures-Odivelas-Hospital Beatriz Angelo /ID# 278357 — Loures, Lisbon District, Portugal
Unidade Local de Saude de Matosinhos EPE /ID# 277980 — Senhora da Hora, Porto District, Portugal
Unidade Local de Saude do Algarve, EPE /ID# 278388 — Faro, Portugal
University Clinical Center Serbia /ID# 278496 — Belgrade, Beograd, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 278499 — Kamenitz, Sremski Okrug, Serbia
Dr Hannes J van Rensburg inc /ID# 278278 — Cape Town, Western Cape, South Africa
Dr JM Engelbrecht Trial Site /ID# 278287 — Somerset West, Western Cape, South Africa
Inje University Haeundae Paik Hospital /ID# 278000 — Busan, Busan Gwang Yeogsi, South Korea
The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068 — Bucheon-si, Gyeonggido, South Korea
Seoul National University Bundang Hospital /ID# 278059 — Seongnam-si, Gyeonggido, South Korea
Yonsei University Health System Severance Hospital /ID# 278166 — Seoul, Seoul Teugbyeolsi, South Korea
Hospital Clinico Universitario de Valencia /ID# 277921 — Valencia, Spain
Hospital Universitari i Politecnic La Fe /ID# 278478 — Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 — Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 278043 — Kaohsiung City, Taiwan
China Medical University Hospital /ID# 278039 — Taichung, Taiwan
National Taiwan University Hospital /ID# 278041 — Taipei, Taiwan
Taipei Veterans General Hospital /ID# 278038 — Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 278042 — Taoyuan City, Taiwan
Gulhane Egitim ve Arastirma Hastanesi /ID# 278944 — Ankara, Antalya, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943 — Istanbul, Turkey (Türkiye)
Royal Papworth Hospital NHS Foundation Trust /ID# 278055 — Cambridge, Cambridgeshire, United Kingdom
Edinburgh Royal Infirmary - NHS Lothian /ID# 278631 — Edinburgh, Edinburgh, City of, United Kingdom
UCLH NHS FT - University College Hospital /ID# 279198 — London, Greater London, United Kingdom
Royal Brompton Hospital /ID# 278007 — London, Greater London, United Kingdom
University Hospital Southampton /ID# 278223 — Southampton, Hampshire, United Kingdom
Norfolk and Norwich University Hospital /ID# 278224 — Norwich, Norfolk, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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