A Phase 2 interventional study of ABBV-142 and Placebo for ABBV-142 in Idiopathic Pulmonary Fibrosis, sponsored by AbbVie. Recruiting at 57 sites in 17 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 165 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
- 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:
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
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
ABBV-142
Placebo for ABBV-142
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.
Time frame: 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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Week 52
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.
Time frame: Week 24
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.
Time frame: Week 52
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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Up to approximately 52 weeks
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.
Time frame: Up to approximately 52 weeks
Plan to share: 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.
Supporting information: Study protocol, Sap
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