2024-518013-25-00
Recruiting
Phase 2
A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis
AbbVie Deutschland GmbH & Co. KG55 sites in 10 countries85 target enrollmentStarted: April 1, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 85
- Locations
- 55
- Primary Endpoint
- Absolute change from baseline in forced vital capacity (mL) at Week 24.
Overview
Brief Summary
To evaluate the safety, tolerability, and efficacy of investigational products as monotherapy or in combinations in adult subjects with Idiopathic Pulmonary Fibrosis (IPF).
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≥ 40 years.
- •History of IPF diagnosis within 7 years of screening visit.
- •Confirmed diagnosis of IPF: a. Diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest high-resolution Computed Tomography (HRCT) scan taken within 12 months of screening visit and, if available, (historical) surgical lung biopsy or transbronchical lung cryobiopsy, AND b. Usual Interstitial Pneumonia (UIP) or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to randomization visit. Patients with an "Indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" histopathology pattern. Subjects with an "Alternative diagnosis" HRCT finding are eligible if clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a "UIP" histopathology pattern.
- •Either stable treatment with antifibrotics for at least 8 weeks prior to screening visit or not treated with antifibrotics for at least 4 weeks prior to screening visit.
- •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.
Exclusion Criteria
- •Relevant airways obstruction defined as pre-bronchodilator forced expiratory volume 1 second (FEV1)/FVC < 0.7 at screening visit.
- •Acute IPF exacerbation diagnosis within 4 months prior to screening and/or during the screening period (investigator determined).
- •Lower respiratory tract infection (e.g., infectious pneumonia, active tuberculosis) requiring antimicrobials within 4 weeks before screening visit and/or during the screening period.
Arms & Interventions
null
Test
Intervention: null (Drug)
Placebo for ABBV-142
Placebo
Intervention: Placebo for ABBV-142 (Drug)
Outcomes
Primary Outcomes
Absolute change from baseline in forced vital capacity (mL) at Week 24.
Absolute change from baseline in forced vital capacity (mL) at Week 24.
Secondary Outcomes
- Absolute change from baseline in FVC (mL) at Week 52.
- Relative change from baseline in FVC (mL) at Week 24.
- Relative change from baseline in FVC (mL) at Week 52.
- Absolute and relative change from Baseline in FVC % predicted at Week 24.
- Absolute and relative change from Baseline in FVC % predicted at Week 52.
- Time to first ≥ 10% absolute decline in FVC% predicted.
- Time to first ≥ 5% absolute decline in FVC% predicted.
Investigators
ABBVIE CALLCENTER
Scientific
AbbVie Deutschland GmbH & Co. KG
Study Sites (55)
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