This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.
This study is designed to evaluate the efficacy and safety of GB0139, a galectin-3 inhibitor, administered by dry powder inhalation over 52 weeks. GB0139, given once per day, will be compared to placebo. GB0139 was previously known as TD139.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Annual Rate of Decline in Forced Vital Capacity (FVC)
Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
Time frame: 52 weeks
Number of Participants With Respiratory Related Hospitalizations
Number of Participants with Respiratory Related Hospitalizations from randomisation (including acute exacerbation of IPF).
Time frame: 52 weeks
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
Change from baseline to WK52 in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.
Time frame: 52 weeks
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