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: 3 countries
• Sites: 6

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 (6)

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

Dothan, Alabama, 36305, United States

RECRUITING

Christie Clinic on University /ID# 277871

Champaign, Illinois, 61820, United States

RECRUITING

Hannibal Regional Hospital /ID# 277984

Hannibal, Missouri, 63401, United States

RECRUITING

Centre d'Investigation Clinique Mauricie /ID# 277949

Trois-Rivières, Quebec, G8T 7A1, Canada

RECRUITING

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

Kaohsiung City, 807, Taiwan

RECRUITING

China Medical University Hospital /ID# 278039

Taichung, 40447, Taiwan

RECRUITING

Related Links

• Related Info

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: April 9, 2026

Record last verified: 2026-04

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

US (3); TW (2); CA (1)