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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518013-25-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-142 | Drug | ABBV-142 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 52 |
| Relative Change From Baseline in FVC (mL) |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sec Clinical Research - East - Dothan - Graceland /ID# 278328 | Recruiting | Dothan | Alabama | 36305 | United States | |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo for ABBV-142 |
| Drug |
Placebo for ABBV-142 |
|
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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to approximately 52 weeks |
| Christie Clinic on University /ID# 277871 |
| Recruiting |
| Champaign |
| Illinois |
| 61820 |
| United States |
| Hannibal Regional Hospital /ID# 277984 | Recruiting | Hannibal | Missouri | 63401 | United States |
| Centre d'Investigation Clinique Mauricie /ID# 277949 | Recruiting | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 | Recruiting | Kaohsiung City | 807 | Taiwan |
| China Medical University Hospital /ID# 278039 | Recruiting | Taichung | 40447 | Taiwan |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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