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ABBV-142

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |AbbVie Inc.|Last Updated: May 6, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment165
FDA Designations
No designations recorded
Clinical trial landscape

ABBV-142 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT07230288Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
RECRUITING165 Analytics
PHASE2RECRUITING
Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary FibrosisUnlock trial analytics
Study Endpoints
Primary Endpoints
Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL)
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.

Percentage of Participants with Adverse Events (AE)
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.

Number of Participants with Adverse Events (AEs)
Up to Day 120

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Maximum Observed Serum Concentration (Cmax) of ABBV-142
Up to Day 120

Cmax of ABBV-142 will be assessed.

Time to Cmax (Tmax) of ABBV-142
Up to Day 120

Tmax of ABBV-142 will be assessed.

Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)
Up to Day 120

AUCt of ABBV-142 will be determined.

AUC of ABBV-142 from Time 0 to Infinity (AUCinf)
Up to Day 120

AUCinf of ABBV-142 will be assessed.

Terminal Phase Elimination Rate Constant (β) of ABBV-142
Up to Day 120

Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.

Terminal Phase Elimination Half-life (t1/2) of ABBV-142
Up to Day 120

Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.

Dose Normalized Cmax of ABBV-142
Up to Day 120

Dose normalized Cmax of ABBV-142 will be assessed.

Dose Normalized AUC of ABBV-142
Up to Day 120

Dose normalized AUC of ABBV-142 will be assessed.

Secondary Endpoints
Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL)
Week 52
Relative Change From Baseline in FVC (mL)
Week 24
Absolute Change from Baseline in FVC% predicted
Up to approximately 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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.
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.
Part 1: Group 1EXPERIMENTALParticipants will receive ABBV-142 Dose A or Placebo on Day 1.
Part 1: Group 2EXPERIMENTALParticipants will receive ABBV-142 Dose B or Placebo on Day 1.
Part 1: Group 3EXPERIMENTALParticipants will receive ABBV-142 Dose C or Placebo on Day 1.
Part 1: Group 4EXPERIMENTALParticipants will receive ABBV-142 Dose D or Placebo on Day 1.
Part 1: Group 5 (Optional)EXPERIMENTALParticipants will receive ABBV-142 Dose TBD or Placebo on Day 1.
Part 2: Group 6EXPERIMENTALParticipants will receive ABBV-142 Dose B or Placebo on Day 1.
Part 2: Group 7EXPERIMENTALParticipants will receive ABBV-142 Dose C or Placebo on Day 1.
Part 3: Group 8EXPERIMENTALHan Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
Part 3: Group 9EXPERIMENTALJapanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
Interventions
NameTypeDescription
ABBV-142DRUGABBV-142
Placebo for ABBV-142DRUGPlacebo for ABBV-142
PlaceboDRUGIV Infusion
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Eligibility Criteria
Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 verificatio...

Countries:United StatesCanadaTaiwan
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Recent Changes (Last 90 Days)
MEDIUMJun 6, 2026NCT06774313TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT06774313TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT06774313TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT06774313TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT06774313TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT06774313TRIAL_REMOVED: changed
LOWMay 26, 2026NCT07230288primaryCompletionDate: changed
HIGHMay 26, 2026NCT06774313Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT07230288studyFirstPostDate: changed
LOWMay 24, 2026NCT06774313studyFirstPostDate: changed