A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients with Severe Asthma not Adequately Controlled with Medium to High Dose ICS/LABA Therapy (PANAIRAMA)

Condition studied

Severe asthma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in predose (pre-bronchodilator) FEV1 (L) from baseline to Week 12

Endpoint detail

1. Incidence of AEs (including SAEs, TEAEs, and AESIs) collected throughout the study, 2. Abnormal findings in clinical safety laboratory evaluations, ECGs, vital signs, and physical examinations throughout the study, 3. Change in predose (pre-bronchodilator) FEV1 (% predicted) from baseline to Week 12, 4. Change in predose (pre-bronchodilator) FEV1 (L) and FEV1 (% predicted) from baseline to Week 2, Week 4, and Week 8, 5. Change in morning and evening PEF from baseline to Week 12, 6. Change in ACQ-6 score from baseline to Week 12, 7. Change in AQLQ score from baseline to Week 12, 8. Change from baseline to Week 12 in other lung function parameters (eg, FVC, FEF25-75%, FEV1/FVC % predicted), 9. Change from baseline to Week 2, Week 4, Week 8, and Week 12 in other lung function parameters (eg, FVC, FEF 25-75%, FEV1/FVC % predicted), 10. Change in AM and PM asthma symptom scores from baseline to Week 121, 11. Change in AM and PM SABA rescue medication use (puffs) from baseline to Week 12, 12. Change in nighttime awakenings due to asthma from baseline to Week 12, 13. Symptom-free 24-hour periods (symptom-free days) to Week 12, 14. Asthma control 24-hour periods (asthma control days) to Week 12, 15. Rescue-free 24-hour periods (rescue-free days) to Week 12, 16. Rate of severe asthma exacerbations and time to first severe asthma exacerbation, 17. Rate of asthma worsening events and time to first asthma worsening event, 18. Rate of exacerbations via CompEx algorithm and time to first CompEx event, 19. Change from baseline to Week 12 and change from baseline to Week 2, Week 4, Week 8, and Week 12 in predose (pre-bronchodilator) FeNO levels, 20. Change from baseline to Week 12 in EQ-5D-5L, 21. Change from baseline to Week 12 in WPAI+CIQ, 22. PGI-C, CGI-C, and PGI-S general assessments at Week 12/EOT, 23. Serial PK parameters for frevecitinib and its metabolite [CCI], including but not limited to; Cmax, Tmax, AUC, and T1/2 following the first dose and at steady state, 24. Population PK analysis