ABBV-142 to check side effects and changes in disease activity in adults with idiopathic pulmonary fibrosis.
A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis
Adults with idiopathic pulmonary fibrosis will be randomly given ABBV-142 or a placebo to see if ABBV-142 is safe and changes disease activity.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 6 sites (Dothan, Alabama and 5 other locations) |
| Trial ID | NCT07230288 on ClinicalTrials.gov |
What this trial studies
This Phase 2 platform study randomizes adults with centrally confirmed IPF to receive ABBV-142 or matching placebo in Substudy 1. The master protocol design allows multiple treatments or substudies to be added or closed over time under the same framework. The main goals are to measure safety, tolerability, and changes in disease activity using centrally read HRCT and clinical assessments. Eligible participants must have IPF diagnosed within seven years with a usual or probable UIP pattern and meet other inclusion/exclusion criteria.
Who should consider this trial
Good fit: Adults diagnosed with IPF within the past seven years whose diagnosis is supported by a centrally read HRCT showing UIP or probable UIP and who meet other health criteria (for example no recent stroke or disqualifying malignancy) are the best fit.
Not a fit: People with other clinically significant pulmonary abnormalities, a recent stroke, recent disqualifying cancer history, or who cannot attend one of the study sites are less likely to benefit from participation.
Why it matters
Potential benefit: If ABBV-142 works, it could slow lung scarring and improve breathing and quality of life for people with IPF.
How similar studies have performed: Some anti-fibrotic approaches have shown benefit in IPF, but ABBV-142 itself is investigational and not yet proven effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dothan, Alabama and 5 other locations
- Sec Clinical Research - East - Dothan - Graceland /ID# 278328 — Dothan, Alabama, United States (Recruiting)
- Christie Clinic on University /ID# 277871 — Champaign, Illinois, United States (Recruiting)
- Hannibal Regional Hospital /ID# 277984 — Hannibal, Missouri, United States (Recruiting)
- Centre d'Investigation Clinique Mauricie /ID# 277949 — Trois-Rivières, Quebec, Canada (Recruiting)
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 — Kaohsiung City, Taiwan (Recruiting)
- China Medical University Hospital /ID# 278039 — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.