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

September 1, 2026 updated by: AbbVie

A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Nundah, Queensland, Australia, 4012
        • Recruiting
        • Lung Research Queensland /ID# 278838
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Eastern Health /ID# 278245
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • University Multiprofile Hospital For Active Treatment Sveti Georgi - Plovdiv /ID# 279367
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Diagnostic Consultative Center Convex /ID# 277848
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Diagnostic Consultative Center Convex /ID# 277849
  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Recruiting
        • Centre d'Investigation Clinique Mauricie /ID# 277949
  • France
    • Herault
      • Montpellier, Herault, France, 34090
        • Recruiting
        • Hopital Arnaud de Villeneuve /ID# 278322
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 278333
    • Île-de-France Region
      • Bobigny, Île-de-France Region, France, 93000
        • Recruiting
        • Hopital Avicenne /ID# 279212
  • Germany
    • Baden-Wurttemberg
      • Konstanz, Baden-Wurttemberg, Germany, 78464
        • Recruiting
        • Klinikum Konstanz /ID# 278139
    • Bavaria
      • Donaustauf, Bavaria, Germany, 93093
        • Recruiting
        • Caritas-Krankenhaus St. Maria gGmbH /ID# 278138
  • Greece
      • Ioannina, Greece, 45500
        • Recruiting
        • University Hospital of Ioannina /ID# 277719
      • Thessaloniki, Greece, 57010
        • Recruiting
        • General Hospital of Thessaloniki George Papanikolaou /ID# 277819
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Recruiting
        • University General Hospital of Patras /ID# 277726
    • Attica
      • Athens, Attica, Greece, 11527
        • Recruiting
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724
    • Crete
      • Heraklion, Crete, Greece, 71500
        • Recruiting
        • University General Hospital of Heraklion /ID# 277717
  • Japan
    • Osaka
      • Sakai-shi, Osaka, Japan, 591-8555
        • Recruiting
        • NHO Kinki Chuo Chest Medical Center /ID# 280225
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
        • Recruiting
        • Vitamed Galaj i Cichomski Sp.j. /ID# 278145
  • Portugal
      • Faro, Portugal, 8000-386
        • Recruiting
        • Unidade Local de Saude do Algarve, EPE /ID# 278388
    • Lisbon District
      • Loures, Lisbon District, Portugal, 2674-514
        • Recruiting
        • Unidade Local de Saude de Loures-Odivelas-Hospital Beatriz Angelo /ID# 278357
    • Porto District
      • Senhora da Hora, Porto District, Portugal, 4464-513
        • Recruiting
        • Unidade Local de Saude de Matosinhos EPE /ID# 277980
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • University Clinical Center Serbia /ID# 278496
    • Sremski Okrug
      • Kamenitz, Sremski Okrug, Serbia, 21208
        • Recruiting
        • Institute For Pulmonary Diseases Of Vojvodina /ID# 278499
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Recruiting
        • Dr Hannes J van Rensburg inc /ID# 278278
      • Somerset West, Western Cape, South Africa, 7130
        • Recruiting
        • Dr JM Engelbrecht Trial Site /ID# 278287
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital /ID# 278000
    • Gyeonggido
      • Bucheon-si, Gyeonggido, South Korea, 14647
        • Recruiting
        • The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital /ID# 278059
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 278166
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe /ID# 278478
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia /ID# 277921
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital /ID# 278043
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital /ID# 278039
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital /ID# 278041
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital /ID# 278038
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital /ID# 278042
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943
    • Antalya
      • Ankara, Antalya, Turkey (Türkiye), 06010
        • Recruiting
        • Gulhane Egitim ve Arastirma Hastanesi /ID# 278944
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust /ID# 278055
    • Edinburgh, City of
      • Edinburgh, Edinburgh, City of, United Kingdom, EH16 4SA
        • Recruiting
        • Edinburgh Royal Infirmary - NHS Lothian /ID# 278631
    • Greater London
      • London, Greater London, United Kingdom, NW1 2BU
        • Recruiting
        • UCLH NHS FT - University College Hospital /ID# 279198
      • London, Greater London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton Hospital /ID# 278007
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton /ID# 278223
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital /ID# 278224
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The University of Alabama at Birmingham /ID# 277613
      • Dothan, Alabama, United States, 36305
        • Recruiting
        • Sec Clinical Research - East - Dothan - Graceland /ID# 278328
    • Florida
      • Kissimmee, Florida, United States, 34746
        • Recruiting
        • Clinical Research Specialists - Kissimmee /ID# 279184
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Recruiting
        • Christie Clinic on University /ID# 277871
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System - Ann Arbor /ID# 279994
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital /ID# 277843
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Recruiting
        • Hannibal Regional Hospital /ID# 277984
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Jefferson Health Honickman Center /ID# 279127
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital /ID# 278469
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University Medical Center /ID# 277992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Substudy 1: ABBV-142
Participants will receive ABBV-142 for 52 week during double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks during open-label treatment period.
Drug: ABBV-142
ABBV-142
Placebo Comparator: Substudy 1: Placebo for ABBV-142
Participants will receive placebo for ABBV-142 for 52 week during double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks during open-label treatment period.
Drug: ABBV-142
ABBV-142
Drug: Placebo for ABBV-142
Placebo for ABBV-142

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL)
Time Frame: Week 24
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Week 24
Percentage of Participants with Adverse Events (AE)
Time Frame: Up to approximately 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to approximately 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL)
Time Frame: Week 52
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Week 52
Relative Change From Baseline in FVC (mL)
Time Frame: Week 24
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Week 24
Relative Change From Baseline in FVC (ml)
Time Frame: Week 52
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Week 52
Absolute Change from Baseline in FVC% predicted
Time Frame: Up to approximately 52 weeks
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Up to approximately 52 weeks
Relative Change From Baseline in FVC% predicted
Time Frame: Up to approximately 52 weeks
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Up to approximately 52 weeks
Change From Baseline in Living with Pulmonary Fibrosis (L-PF) Overall Score
Time Frame: Up to approximately 52 weeks
L-PF questionnaire is a 49-item disease specific PRO that assesses symptoms and impacts of living with pulmonary fibrosis among participants with fibrosing interstitial lung disease (ILD). Summary scores range from 0-100, the higher the score the greater the impairment.
Up to approximately 52 weeks
Time to First Absolute Decline From Baseline in FVC% Predicted of >= 10%
Time Frame: Up to approximately 52 weeks
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Up to approximately 52 weeks
Time to First Relative Decline From Baseline in FVC% Predicted of >= 10%
Time Frame: Up to approximately 52 weeks
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Up to approximately 52 weeks
Time to First Absolute Decline From Baseline in FVC% Predicted >= 5%
Time Frame: Up to approximately 52 weeks
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Up to approximately 52 weeks
Time to First Relative Decline From Baseline in FVC% Predicted >= 5%
Time Frame: Up to approximately 52 weeks
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.
Up to approximately 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-268
  • 2024-518013-25-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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