17 February 2023
Sponsored: Pulmonary Arterial Hypertension clinical trial
INSIGNIA-PAH:
A Phase 2/3 study of an inhaled sGC stimulator to evaluate the efficacy and safety of MK-5475 in adults with Pulmonary Arterial Hypertension (PAH).
Trial participants
Participants may qualify to be enrolled if:
- Male or female, from 18 years to 75 years of age (inclusive)
- Diagnosis of the following PAH sub-groups: Idiopathic PAH, Heritable PAH, Drug and toxin-induced PAH, PAH associated with connective tissue disease, HIV infection or simple repaired congenital systemic-to-pulmonary shunt with persistent PH ≥1 year after surgical repair
- Diagnosis of PAH performed as standard of care, per scientific guidelines, and documented by RHC
- Eligibility RHC, meeting all the following criteria: mPAP ≥25 mmHg, PVR of ≥3 Wood units, PCWP or LVEDP ≤15 mmHg
- WHO-FC II to IV
- Two 6MWD measurements between 150 and 500 meters (Screening & Randomization)
- Stable concomitant background PAH-specific therapy (no change in drug within 90 days and no change in dosage within 30 days prior to and over the duration of Screening)
- Other criteria apply
The ongoing Phase 2 segment of the trial has 3 parts:
- Screening period up to 4 weeks long
- Trial Base Period for 12 weeks
- Trial extension (Optional) for 24 months
Trial medication
MK-5475 is a dry powder for once daily oral inhalation using a dry powder inhaler.
Trial procedures
Include physical examination, laboratory tests, ECG, echocardiography, pulmonary function tests, right heart catheterization, 6-minute walk test, and QoL questionnaires.
