Recruiting
Phase 2

ABBV-142

Sponsor:

AbbVie

Code:

NCT07230288

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

ABBV-142

Placebo for ABBV-142

Study Details

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

Study ID

NCT07230288

Start date

Jan 23, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

ABBV-142

ABBV-142

Placebo for ABBV-142

Placebo for ABBV-142

Primary outcome measure

  • Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) [ Time Frame: Week 24 ]
  • Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to approximately 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

The University of Alabama at Birmingham /ID# 277613

Recruiting

Birmingham, Alabama, United States, 35233

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

Recruiting

Dothan, Alabama, United States, 36305

Clinical Research Specialists - Kissimmee /ID# 279184

Recruiting

Kissimmee, Florida, United States, 34746

Christie Clinic on University /ID# 277871

Recruiting

Champaign, Illinois, United States, 61820

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital /ID# 277843

Recruiting

Detroit, Michigan, United States, 48202

Hannibal Regional Hospital /ID# 277984

Recruiting

Hannibal, Missouri, United States, 63401

Jefferson Health Honickman Center /ID# 279127

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Inova Fairfax Hospital /ID# 278469

Recruiting

Falls Church, Virginia, United States, 22042

Virginia Commonwealth University Medical Center /ID# 277992

Recruiting

Richmond, Virginia, United States, 23219

Centre d'Investigation Clinique Mauricie /ID# 277949

Recruiting

Trois-Rivières, Quebec, Canada, G8T 7A1

More Information

Sponsor

AbbVie

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Idiopathic Pulmonary Fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-03.