An Open-label Study to Evaluate the Safety and Tolerability of LIQ861 in Participants With WHO Group 1 PAH Transitioning From Oral Selexipag to Inhaled Treprostinil
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Liquidia Technologies, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Study Overview
Brief Summary
This study will look at safety and tolerability of LIQ861 (treprostinil) inhalation powder in adults with pulmonary arterial hypertension (PAH, WHO Group 1) who switch from selexipag, a medicine taken by mouth, to treprostinil, a medicine breathed into the lungs.
Everyone who takes part will receive LIQ861. On the first study day, participants will stop taking selexipag and begin taking LIQ861 four times a day using a small handheld dry powder inhaler. The dose may be increased over time based on how well it is tolerated. Participants will take LIQ861 for 16 weeks.
The study will also look at whether switching to LIQ861 affects walking distance, a blood marker of heart strain, and symptoms reported by participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female 18 to 80 years of age
- •Documented findings on right heart catheterization consistent with a diagnosis of WHO Group 1 pulmonary arterial hypertension of one of the following subtypes: idiopathic PAH; heritable PAH; drug- or toxin-induced PAH; PAH associated with connective tissue disease; or PAH associated with simple congenital systemic-to-pulmonary shunts repaired at least 1 year previously
- •Receiving selexipag at any dose between 200 and 1600 mcg twice daily for at least 90 days, and willing and able to transition from selexipag to LIQ861 due to unsatisfactory clinical response or tolerability issues
- •May be receiving up to 2 additional approved non-prostacyclin oral PAH therapies at a stable dose and regimen, planned to continue unchanged for the duration of the study
- •New York Heart Association Functional Class II or III
- •Able to demonstrate correct use of the dry powder inhaler
Exclusion Criteria
- •Pulmonary hypertension in WHO Group 2, 3, 4, or 5, or a WHO Group 1 subtype not listed in the inclusion criteria
- •Clinically significant left-sided heart disease by echocardiography, including left ventricular ejection fraction ≤ 45%, left atrial volume index > 48 mL/m², or hemodynamically significant valvular disease
- •Symptomatic coronary artery disease within the previous 6 months
- •Prior atrial septostomy
Arms & Interventions
Selexipag to LIQ861 (treprostinil) inhalation powder
Intervention: LIQ861 (treprostinil) inhalation powder (Combination Product)
Outcomes
Primary Outcomes
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: Day 1 through 30 days after the last dose of study drug (up to approximately 24 weeks)
Secondary Outcomes
No secondary outcomes reported