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

Phase 2RecruitingNCT07230288

AbbVie165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

165

Interventions

ABBV-142DRUG

ABBV-142

Placebo for ABBV-142DRUG

Placebo for ABBV-142

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (57)

The University of Alabama at Birmingham /ID# 277613

Birmingham, Alabama, United States

RECRUITING

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

Dothan, Alabama, United States

RECRUITING

Clinical Research Specialists - Kissimmee /ID# 279184

Kissimmee, Florida, United States

RECRUITING

Christie Clinic on University /ID# 277871

Champaign, Illinois, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Ann Arbor, Michigan, United States

RECRUITING

Henry Ford Hospital /ID# 277843

Detroit, Michigan, United States

RECRUITING

Hannibal Regional Hospital /ID# 277984

Hannibal, Missouri, United States

RECRUITING

Jefferson Health Honickman Center /ID# 279127

Philadelphia, Pennsylvania, United States

RECRUITING

Inova Fairfax Hospital /ID# 278469

Falls Church, Virginia, United States

RECRUITING

Virginia Commonwealth University Medical Center /ID# 277992

Richmond, Virginia, United States

RECRUITING

...and 47 more locations

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

Overview

Conditions

Interventions

Eligibility

Locations (57)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts