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

NCT07230288 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: M25-2682024-518013-25-00
• Study Type: interventional
• Target: 165
• Locations: 17 countries
• Sites: 57

Brief 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. 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 24

• 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.

  Up to approximately 52 weeks

Secondary Outcomes (10)

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

  Week 52

• Relative Change From Baseline in FVC (mL)

  Week 24

• Relative Change From Baseline in FVC (ml)

  Week 52

• Absolute Change from Baseline in FVC% predicted

  Up to approximately 52 weeks

• Relative Change From Baseline in FVC% predicted

  Up to approximately 52 weeks

Study Arms (2)

Substudy 1: ABBV-142

EXPERIMENTAL

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

Substudy 1: Placebo for ABBV-142

PLACEBO COMPARATOR

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; Drug: Placebo for ABBV-142

Interventions

ABBV-142 DRUG

ABBV-142

Substudy 1: ABBV-142; Substudy 1: Placebo for ABBV-142

Placebo for ABBV-142 DRUG

Placebo for ABBV-142

Substudy 1: Placebo for ABBV-142

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (57)

The University of Alabama at Birmingham /ID# 277613

Birmingham, Alabama, 35233, United States

RECRUITING

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

Dothan, Alabama, 36305, United States

RECRUITING

Clinical Research Specialists - Kissimmee /ID# 279184

Kissimmee, Florida, 34746, United States

RECRUITING

Christie Clinic on University /ID# 277871

Champaign, Illinois, 61820, United States

RECRUITING

University of Michigan Health System - Ann Arbor /ID# 279994

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Hospital /ID# 277843

Detroit, Michigan, 48202, United States

RECRUITING

Hannibal Regional Hospital /ID# 277984

Hannibal, Missouri, 63401, United States

RECRUITING

Jefferson Health Honickman Center /ID# 279127

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Inova Fairfax Hospital /ID# 278469

Falls Church, Virginia, 22042, United States

RECRUITING

Virginia Commonwealth University Medical Center /ID# 277992

Richmond, Virginia, 23219, United States

RECRUITING

Lung Research Queensland /ID# 278838

Nundah, Queensland, 4012, Australia

RECRUITING

Eastern Health /ID# 278245

Box Hill, Victoria, 3128, Australia

RECRUITING

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845

Pleven, 5800, Bulgaria

RECRUITING

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

Plovdiv, 4002, Bulgaria

RECRUITING

Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846

Sofia, 1407, Bulgaria

RECRUITING

Diagnostic Consultative Center Convex /ID# 277848

Sofia, 1680, Bulgaria

RECRUITING

Diagnostic Consultative Center Convex /ID# 277849

Sofia, 1680, Bulgaria

RECRUITING

Centre d'Investigation Clinique Mauricie /ID# 277949

Trois-Rivières, Quebec, G8T 7A1, Canada

RECRUITING

Hopital Arnaud de Villeneuve /ID# 278322

Montpellier, Herault, 34090, France

RECRUITING

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

Rennes, Ille-et-Vilaine, 35033, France

RECRUITING

Hopital Avicenne /ID# 279212

Bobigny, Île-de-France Region, 93000, France

RECRUITING

Klinikum Konstanz /ID# 278139

Konstanz, Baden-Wurttemberg, 78464, Germany

RECRUITING

Caritas-Krankenhaus St. Maria gGmbH /ID# 278138

Donaustauf, Bavaria, 93093, Germany

RECRUITING

University General Hospital of Patras /ID# 277726

Pátrai, Achaia, 26504, Greece

RECRUITING

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724

Athens, Attica, 11527, Greece

RECRUITING

University General Hospital of Heraklion /ID# 277717

Heraklion, Crete, 71500, Greece

RECRUITING

University Hospital of Ioannina /ID# 277719

Ioannina, 45500, Greece

RECRUITING

General Hospital of Thessaloniki George Papanikolaou /ID# 277819

Thessaloniki, 57010, Greece

RECRUITING

NHO Kinki Chuo Chest Medical Center /ID# 280225

Sakai-shi, Osaka, 591-8555, Japan

RECRUITING

Vitamed Galaj i Cichomski Sp.j. /ID# 278145

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

RECRUITING

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

Loures, Lisbon District, 2674-514, Portugal

RECRUITING

Unidade Local de Saude de Matosinhos EPE /ID# 277980

Senhora da Hora, Porto District, 4464-513, Portugal

RECRUITING

Unidade Local de Saude do Algarve, EPE /ID# 278388

Faro, 8000-386, Portugal

RECRUITING

University Clinical Center Serbia /ID# 278496

Belgrade, Beograd, 11000, Serbia

RECRUITING

Institute For Pulmonary Diseases Of Vojvodina /ID# 278499

Kamenitz, Sremski Okrug, 21208, Serbia

RECRUITING

Dr Hannes J van Rensburg inc /ID# 278278

Cape Town, Western Cape, 7130, South Africa

RECRUITING

Dr JM Engelbrecht Trial Site /ID# 278287

Somerset West, Western Cape, 7130, South Africa

RECRUITING

Inje University Haeundae Paik Hospital /ID# 278000

Busan, Busan Gwang Yeogsi, 48108, South Korea

RECRUITING

The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068

Bucheon-si, Gyeonggido, 14647, South Korea

RECRUITING

Seoul National University Bundang Hospital /ID# 278059

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 278166

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Hospital Clinico Universitario de Valencia /ID# 277921

Valencia, 46010, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe /ID# 278478

Valencia, 46026, Spain

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029

Kaohsiung City, 807, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital /ID# 278043

Kaohsiung City, 833, Taiwan

RECRUITING

China Medical University Hospital /ID# 278039

Taichung, 40447, Taiwan

RECRUITING

National Taiwan University Hospital /ID# 278041

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital /ID# 278038

Taipei, 112, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 278042

Taoyuan City, 333, Taiwan

RECRUITING

Gulhane Egitim ve Arastirma Hastanesi /ID# 278944

Ankara, Antalya, 06010, Turkey (Türkiye)

RECRUITING

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Royal Papworth Hospital NHS Foundation Trust /ID# 278055

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

RECRUITING

Edinburgh Royal Infirmary - NHS Lothian /ID# 278631

Edinburgh, Edinburgh, City of, EH16 4SA, United Kingdom

RECRUITING

UCLH NHS FT - University College Hospital /ID# 279198

London, Greater London, NW1 2BU, United Kingdom

RECRUITING

Royal Brompton Hospital /ID# 278007

London, Greater London, SW3 6NP, United Kingdom

RECRUITING

University Hospital Southampton /ID# 278223

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital /ID# 278224

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

ES (2); FR (3); US (10); TW (6); JP (1); CA (1); GB (6); DE (2); TU (2); BU (5); GR (5); PL (1); SE (2); ZA (2); PT (3); KR (4); AU (2)