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Idiopathic Pulmonary FibrosisPhase 2NCT07230288

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

A Phase 2 study testing ABBV-142 in people with Idiopathic Pulmonary Fibrosis, run by AbbVie at 57 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
ABBV-142
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
57 sitesin 17 countries
Study dates
23 Jan 2026to Sep 2029
Phase
Phase 2
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

57 sites in 17 countries

United States10 sites, 10 recruiting
  • University of Michigan Health System - Ann Arbor /ID# 279994

    Ann Arbor, Michigan, 48109

    Recruiting
  • The University of Alabama at Birmingham /ID# 277613

    Birmingham, Alabama, 35233

    Recruiting
  • Christie Clinic on University /ID# 277871

    Champaign, Illinois, 61820

    Recruiting
  • Henry Ford Hospital /ID# 277843

    Detroit, Michigan, 48202

    Recruiting
  • Sec Clinical Research - East - Dothan - Graceland /ID# 278328

    Dothan, Alabama, 36305

    Recruiting
  • Inova Fairfax Hospital /ID# 278469

    Falls Church, Virginia, 22042

    Recruiting
  • Hannibal Regional Hospital /ID# 277984

    Hannibal, Missouri, 63401

    Recruiting
  • Clinical Research Specialists - Kissimmee /ID# 279184

    Kissimmee, Florida, 34746

    Recruiting
  • Jefferson Health Honickman Center /ID# 279127

    Philadelphia, Pennsylvania, 19107

    Recruiting
  • Virginia Commonwealth University Medical Center /ID# 277992

    Richmond, Virginia, 23219

    Recruiting

Other trials in United States

Taiwan6 sites, 6 recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029

    Kaohsiung City, 807

    Recruiting
  • Kaohsiung Chang Gung Memorial Hospital /ID# 278043

    Kaohsiung City, 833

    Recruiting
  • China Medical University Hospital /ID# 278039

    Taichung, 40447

    Recruiting
  • National Taiwan University Hospital /ID# 278041

    Taipei, 100

    Recruiting
  • Taipei Veterans General Hospital /ID# 278038

    Taipei, 112

    Recruiting
  • Linkou Chang Gung Memorial Hospital /ID# 278042

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

United Kingdom6 sites, 6 recruiting
  • Royal Papworth Hospital NHS Foundation Trust /ID# 278055

    Cambridge, Cambridgeshire, CB2 0AY

    Recruiting
  • Edinburgh Royal Infirmary - NHS Lothian /ID# 278631

    Edinburgh, Edinburgh, City of, EH16 4SA

    Recruiting
  • UCLH NHS FT - University College Hospital /ID# 279198

    London, Greater London, NW1 2BU

    Recruiting
  • Royal Brompton Hospital /ID# 278007

    London, Greater London, SW3 6NP

    Recruiting
  • Norfolk and Norwich University Hospital /ID# 278224

    Norwich, Norfolk, NR4 7UY

    Recruiting
  • University Hospital Southampton /ID# 278223

    Southampton, Hampshire, SO16 6YD

    Recruiting

Other trials in United Kingdom

Bulgaria5 sites, 5 recruiting
  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845

    Pleven, 5800

    Recruiting
  • University Multiprofile Hospital For Active Treatment Sveti Georgi - Plovdiv /ID# 279367

    Plovdiv, 4002

    Recruiting
  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846

    Sofia, 1407

    Recruiting
  • Diagnostic Consultative Center Convex /ID# 277848

    Sofia, 1680

    Recruiting
  • Diagnostic Consultative Center Convex /ID# 277849

    Sofia, 1680

    Recruiting

Other trials in Bulgaria

Greece5 sites, 5 recruiting
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724

    Athens, Attica, 11527

    Recruiting
  • University General Hospital of Heraklion /ID# 277717

    Heraklion, Crete, 71500

    Recruiting
  • University Hospital of Ioannina /ID# 277719

    Ioannina, 45500

    Recruiting
  • University General Hospital of Patras /ID# 277726

    Pátrai, Achaia, 26504

    Recruiting
  • General Hospital of Thessaloniki George Papanikolaou /ID# 277819

    Thessaloniki, 57010

    Recruiting

Other trials in Greece

South Korea4 sites, 4 recruiting
  • The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068

    Bucheon-si, Gyeonggido, 14647

    Recruiting
  • Inje University Haeundae Paik Hospital /ID# 278000

    Busan, Busan Gwang Yeogsi, 48108

    Recruiting
  • Seoul National University Bundang Hospital /ID# 278059

    Seongnam-si, Gyeonggido, 13620

    Recruiting
  • Yonsei University Health System Severance Hospital /ID# 278166

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

Other trials in South Korea

France3 sites, 3 recruiting
  • Hopital Avicenne /ID# 279212

    Bobigny, Île-de-France Region, 93000

    Recruiting
  • Hopital Arnaud de Villeneuve /ID# 278322

    Montpellier, Herault, 34090

    Recruiting
  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 278333

    Rennes, Ille-et-Vilaine, 35033

    Recruiting

Other trials in France

Portugal3 sites, 3 recruiting
  • Unidade Local de Saude do Algarve, EPE /ID# 278388

    Faro, 8000-386

    Recruiting
  • Unidade Local de Saude de Loures-Odivelas-Hospital Beatriz Angelo /ID# 278357

    Loures, Lisbon District, 2674-514

    Recruiting
  • Unidade Local de Saude de Matosinhos EPE /ID# 277980

    Senhora da Hora, Porto District, 4464-513

    Recruiting

Other trials in Portugal

Australia2 sites, 2 recruiting
  • Eastern Health /ID# 278245

    Box Hill, Victoria, 3128

    Recruiting
  • Lung Research Queensland /ID# 278838

    Nundah, Queensland, 4012

    Recruiting

Other trials in Australia

Germany2 sites, 2 recruiting
  • Caritas-Krankenhaus St. Maria gGmbH /ID# 278138

    Donaustauf, Bavaria, 93093

    Recruiting
  • Klinikum Konstanz /ID# 278139

    Konstanz, Baden-Wurttemberg, 78464

    Recruiting

Other trials in Germany

Serbia2 sites, 2 recruiting
  • University Clinical Center Serbia /ID# 278496

    Belgrade, Beograd, 11000

    Recruiting
  • Institute For Pulmonary Diseases Of Vojvodina /ID# 278499

    Kamenitz, Sremski Okrug, 21208

    Recruiting

Other trials in Serbia

South Africa2 sites, 2 recruiting
  • Dr Hannes J van Rensburg inc /ID# 278278

    Cape Town, Western Cape, 7130

    Recruiting
  • Dr JM Engelbrecht Trial Site /ID# 278287

    Somerset West, Western Cape, 7130

    Recruiting

Other trials in South Africa

Spain2 sites, 2 recruiting
  • Hospital Clinico Universitario de Valencia /ID# 277921

    Valencia, 46010

    Recruiting
  • Hospital Universitari i Politecnic La Fe /ID# 278478

    Valencia, 46026

    Recruiting

Other trials in Spain

Turkey (Türkiye)2 sites, 2 recruiting
  • Gulhane Egitim ve Arastirma Hastanesi /ID# 278944

    Ankara, Antalya, 06010

    Recruiting
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943

    Istanbul, 34899

    Recruiting

Other trials in Turkey (Türkiye)

Canada1 site, 1 recruiting
  • Centre d'Investigation Clinique Mauricie /ID# 277949

    Trois-Rivières, Quebec, G8T 7A1

    Recruiting

Other trials in Canada

Japan1 site, 1 recruiting
  • NHO Kinki Chuo Chest Medical Center /ID# 280225

    Sakai-shi, Osaka, 591-8555

    Recruiting

Other trials in Japan

Poland1 site, 1 recruiting
  • Vitamed Galaj i Cichomski Sp.j. /ID# 278145

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

    Recruiting

Other trials in Poland

About this study

Official title: 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.

Read more

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.

Being tested
ABBV-142, Placebo for ABBV-142
Keywords
Idiopathic Pulmonary Fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • ABBV-142Drug

    ABBV-142

  • Placebo for ABBV-142Drug

    Placebo for ABBV-142

Study groups in NCT07230288
Study groupRoleWhat they receive
Substudy 1: ABBV-142ExperimentalParticipants 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.
Receives: Drug: ABBV-142
Substudy 1: Placebo for ABBV-142Placebo comparatorParticipants 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.
Receives: Drug: ABBV-142; Drug: Placebo for ABBV-142

What is being measured

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

  1. Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL)

    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.

    Measured: Week 24

  2. Percentage of Participants with Adverse Events (AE)

    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.

    Measured: Up to approximately 52 weeks

Secondary outcomes (10)
  1. Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL)

    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.

    Measured: Week 52

  2. Relative Change From Baseline in FVC (mL)

    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.

    Measured: Week 24

  3. Relative Change From Baseline in FVC (ml)

    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.

    Measured: Week 52

  4. Absolute Change from Baseline in FVC% predicted

    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.

    Measured: Up to approximately 52 weeks

  5. Relative Change From Baseline in FVC% predicted

    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.

    Measured: Up to approximately 52 weeks

  6. Change From Baseline in Living with Pulmonary Fibrosis (L-PF) Overall Score

    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.

    Measured: Up to approximately 52 weeks

  7. Time to First Absolute Decline From Baseline in FVC% Predicted of >= 10%

    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.

    Measured: Up to approximately 52 weeks

  8. Time to First Relative Decline From Baseline in FVC% Predicted of >= 10%

    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.

    Measured: Up to approximately 52 weeks

  9. Time to First Absolute Decline From Baseline in FVC% Predicted >= 5%

    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.

    Measured: Up to approximately 52 weeks

  10. Time to First Relative Decline From Baseline in FVC% Predicted >= 5%

    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.

    Measured: Up to approximately 52 weeks

Timeline

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

  1. First posted17 Nov 2025
  2. Study start23 Jan 2026
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230288
Sponsor's protocol ID
M25-268
Other IDs
2024-518013-25-00
Status last verified
Sep 2026
First submitted
14 Nov 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-142 in people with Idiopathic Pulmonary Fibrosis, run by AbbVie at 57 sites in 17 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Taiwan, United Kingdom, Bulgaria, Greece and 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Sep 2026.

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