Respiratory
Conditions
Interventions
ABBV142 Placebo
ABBV142
Sponsors
AbbVie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participants if judged by the investigator to have decision making capacity must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures. 2. Individuals at least 40 years old on the day of signing the ICF. 3. Laboratory values criteria met within the screening period prior to the first dose of study drug. 4. Are willing and able to comply with procedures required in this protocol. 5. Participants must not be incarcerated and must be freely willing and able to provide informed consent. 6.History of IPF diagnosis within 7 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis. 7. Participant meets the following disease criteria: • Confirmed diagnosis of IPF • FVC = 45% of predicted normal at screening visit. • Percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin [Hb] in a single breath = 25% at screening visit. 8. Participants are judged to be in a stable general health. 9. Pregnancy testing in female subjects of childbearing potential 10. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, during the study and through the end of the follow-up period. Female participants of nonchildbearing potential do not need to use birth control. 11. Female participant who is not pregnant or breastfeeding, and is not considering becoming pregnant or donating eggs during the study through the end of the follow-up period after the last dose of study drug. 12. No recent changes or planned changes to the dose or regimen for IPF therapy.
Exclusion criteria
Exclusion criteria: 1. History of any malignancy up to 5 years prior screening, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix. 2. History of clinically significant drug or alcohol abuse within the last 6 months. 3. History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study. 4. History of an allergic reaction or significant sensitivity to constituents of the study drug and/or other products in the same class. 5. Clinically relevant or significant ECG abnormalities. 6. Relevant airways obstruction. 7. Emphysema = 50% on HRCT assessed by a central reader, or the extent of emphysema is greater than the extent of fibrosis on the most recent HRCT. 8. Other clinically significant pulmonary abnormalities. 9. Acute IPF exacerbation diagnosis within 4 months prior to screening visit and/or during the screening period. 10. Lower respiratory tract infection requiring antimicrobials within 4 weeks before screening visit and/or during the screening period. 11. History of stroke within 6 months prior to screening. 12. History of clinically significant cardiac disease or uncontrolled atrial or ventricular cardiac arrhythmias. 13. Major surgery performed within 3 months prior to randomization or planned during the trial period. Registration on lung transplantation list would not be considered as planned major surgery. 14. Inability to refrain from smoking on study visit days. 15. High likelihood of lung transplantation within 6 months after Day 1. 16. Known clinically significant pulmonary hypertension requiring PH-specific treatment. 17. Subjects with the following chronic or active infections: Active HBV or HCV infection 18. Are infected with HIV, defined as confirmed positive anti-HIV Ab test. 19. Participants with a significant disease other than IPF, which may put the patient at risk. 20. 20. Subject treated with any investigational drug within 30 days or 5 half-lives of the drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the absolute change from baseline in FVC (mL) at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Absolute change from baseline in FVC (mL) at Week 52 (if applicable). • Relative change from baseline in FVC (mL) at Week 24. • Relative change from baseline in FVC (ml) at Week 52 (if applicable). • Absolute and relative change from Baseline in FVC % predicted at Week 24. • Absolute and relative change from Baseline in FVC % predicted at Week 52 (if applicable) | — |
Countries
South Africa
Contacts
Public ContactStefanie Marais
Country Clinical Operations Manager
Outcome results
None listed