A Phase 2 Study of the Activity and Safety of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Summary

Participation Requirements

Description

This is a Phase 2, randomized, open-label, multicenter study in subjects with IPF who had either received pirfenidone and/or nintedanib or had been offered both treatments. Approximately 81 eligible subjects with IPF will be randomly enrolled in a 2:1 ratio (KD025 to BSC) to 1 of 2 treatment groups:...

This is a Phase 2, randomized, open-label, multicenter study in subjects with IPF who had either received pirfenidone and/or nintedanib or had been offered both treatments. Approximately 81 eligible subjects with IPF will be randomly enrolled in a 2:1 ratio (KD025 to BSC) to 1 of 2 treatment groups: Treatment Group 1 (Experimental): Receive KD025 400 mg orally QD for 24 weeks Treatment Group 2 (Control): Receive BSC, deemed appropriate by the Investigator, for 24 weeks Screening Period: The Screening Period is up to 29 days prior to entry into the study. Treatment Period: After the Screening Visit, subjects will visit the site at Baseline (Week 1 Day 1), and the end of Weeks 4, 8, 12, 16, 20, and 24 (± 3 days). Subjects in Treatment Group 1 will receive their first dose of KD025 in the clinic on Week 1 Day 1. KD025 will then be dispensed for home administration. Subjects in Treatment Group 1 who complete 24 weeks of treatment with KD025 400 mg QD will have the option of continuing therapy with KD025 400 mg QD up to an additional 72 weeks if there are no safety signals and if clinical progress continues. No subject in Treatment Group 1 is permitted to receive therapy with KD025 greater than a total of 96 weeks. Subjects in Treatment Group 2 who complete 24 weeks of BSC will have the option of crossing over to therapy with KD025 400 mg QD for up to 96 weeks if there are no safety signals and if clinical progress continues. No subject in Treatment Group 2 is permitted to receive KD025 400 mg QD therapy greater than 96 weeks. All subjects will undergo the same assessments. Efficacy assessments include: Pulmonary Function Tests (PFTs), which include FVC; residual volume (RV); and diffusing capacity of the lungs for carbon monoxide [DLCO]); Six-minute walking distance (6MWD); Frequency and severity of IPF exacerbation; Time to acute exacerbation of IPF; High-resolution computed tomography (HRCT); St. George's Respiratory Questionnaire (SGRQ) Safety assessments include: Adverse events (AEs); Serious adverse events (SAEs); Physical examinations (PEs); Vital sign (VS) measurements; Clinical laboratory evaluations (hematology, chemistry, and urinalysis), Electrocardiograms (ECGs); Reasons for treatment discontinuation due to toxicity. Exploratory assessments include biomarkers: Matrix Metalloproteinase-7 (MMP7); Chemokine Ligand 18 (CCL18); Surfactant Protein-D (SPD). Follow-up Period: Follow-up Visits will occur 30 days (± 3 days) after the last dose of KD025. (A Follow-up Visit is not necessary for subjects receiving BSC.) Subjects will undergo the following safety assessments: complete PEs, VS measurements, weight measurements, AE assessments, concomitant medication and procedures assessments, blood sample collection for hematology (including coagulation), chemistry and thyroid function (TSH), pulmonary function tests (PFTs), and urinalysis. If another therapy is started within 30 days after the last dose of study drug, the Follow-up visit will be conducted before the start of the other therapy. Duration of Treatment: Treatment Group 1: Subjects will receive KD025 400 mg QD for 24 weeks. After 24 weeks of therapy, subjects will have the option of continuing therapy with KD025 400 mg QD. Subjects who do not continue KD025 400 mg QD after 24 weeks will remain on study up to a total of 32 weeks: 4 weeks for screening, 24 weeks of treatment with KD025 400 mg QD, and 4 weeks of Follow-up. Subjects who chose to continue therapy with KD025 400 mg QD after 24 weeks will be permitted to remain on-study up to a total of 104 weeks: a 4-week screening, 96-week treatment period with KD025 400 mg QD (an initial 24-week period and an additional 72-week period), and a 4-week Follow-up. No subject will be permitted to receive more than 96 weeks of treatment with KD025 400 mg QD. Treatment Group 2: Subjects will receive BSC for 24 weeks, after which they will have the option to cross over to treatment with KD025 400 mg QD. Subjects who do not cross over will remained on-study up to 32 weeks: 4-week screening, 24-week BSC, and 4-week Follow-up. Subjects who chose to crossover to KD025 400 mg QD therapy therapy are permitted to remain on-study up to 128 weeks: 4-week screening, 24-week BSC, 96-week treatment with KD025 400 mg QD, and 4-week Follow-up. No subject will be permitted to receive more than 96 weeks of treatment with KD025 400 mg QD.

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