MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (NCT06132256) | Clinical Trial Compass
Active — Not RecruitingPhase 2
MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Australia145 participantsStarted 2023-12-11
Plain-language summary
The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society Clinical Practice Guideline (Raghu 2018).
* Chest high-resolution computed tomography (HRCT) performed within 12 months prior to first Screening Visit and according to the minimum requirements for IPF diagnosis by central review based on participant's HRCT only (if no lung biopsy is available) or based on both HRCT and lung biopsy (with application of the different criteria in either situation). If an evaluable HRCT \<12 months prior to Screening is not available, an HRCT can be performed at first Screening Visit to determine eligibility, according to the same requirements as the historical HRCT. If a participant has an indeterminate usual interstitial pneumonia (UIP) pattern and their HRCT is \>6 months old, if in the opinion of the Investigator their disease has progressed, an additional HRCT may be obtained and reviewed for eligibility.
* FVC ≥45% of predicted normal at Screening Visits.
* Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 at Screening Visits.
* DLco ≥30% and ≤90% of predicted, corrected for hemoglobin at first Screening Visit.
Key Exclusion Criteria:
* Abnormalities detected on electrocardiogram (ECG) of either rhythm or conduction that in the opinion of the Investigator are clinical significant. Participants with implantable cardiovascular devices (for…
What they're measuring
1
Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])