The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
Administered as intravenous (IV) infusion
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.
Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])
Time frame: Baseline through Week 26
Time to disease progression
Disease progression is defined as absolute FVC percent predicted decline of ≥10%, or occurrence of lung transplant or all-cause death prior to Week 26.
Time frame: Baseline through Week 26
Annualized rate of decline in FVC percent predicted over 26 weeks
Time frame: Baseline through Week 26
Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26
Time frame: Baseline, Week 26
Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26
Time frame: Baseline, Week 26
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Wallace Street Specialist Centre
Brisbane, Queensland, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
Mackay Hospital & Health Service
West Mackay, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Institute for Respiratory Health
Perth, Western Australia, Australia
OLV Hospital Aalst
Aalst, Oost-Vlaanderen, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium
...and 68 more locations