Current Pulmonary Hypertension Trials
Pharmaceutical Studies
A011-12 - SOTERIA
An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
- Enrollment Status: Open to Enrollment upon successful completion of A011-09, A-011-11, A011-13 or A011-14
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Sotatercept or Placebo
- Sponsor: Acceleron Pharma
- PI: Leslie A. Spikes, MD
A011-13 - HYPERION
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Sotatercept or Placebo
- Sponsor: Acceleron Pharma
- PI: Leslie A. Spikes, MD
A011-14 - ZENITH
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Sotatercept or Placebo
- Sponsor: Acceleron Pharma
- PI: Leslie A. Spikes, MD
A011-16 - CADENCE
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heath Failure with Preserved Injection Fraction (HFpEF).
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Sotatercept or Placebo
- Sponsor: Acceleron Pharma
- PI: Leslie A. Spikes, MD
AV-101-002 - IMPAHCT
IMPAHCT: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled 24-Weeek Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH)
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: AV-101 or Placebo
- Sponsor: Aerovate Therapeutics
- PI: Leslie A. Spikes, MD
GB002-2102 - TORREY OLE
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
- Enrollment Status: Active, Closed to Enrollment
- Study Type: Interventional
- Intervention/Treatment: GB002
- Sponsor: Gossamer Bio
- PI: Leslie A. Spikes, MD
GB002-3101 - PROSERA
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
- Enrollment Status: Recruiting
- Study Type: Interventional
- Intervention/Treatment: Seralutinib or Placebo
- Sponsor: Gossamer Bio
- PI: Leslie A. Spikes, MD
INS1009-202
A Phase 2, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension.
- Enrollment Status: Recruiting
- Study Type: Interventional
- Intervention/Treatment: Treprostinil Palmitil Inhalation Powder or Placebo
- Sponsor: Insmed
- PI: Leslie A. Spikes, MD
INS1009-203
An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
- Enrollment Status: Open to Enrollment upon successful completion of INS1009-202
- Study Type: Interventional
- Intervention/Treatment: Treprostinil Palmitil Inhalation Powder
- Sponsor: Insmed
- PI: Leslie A. Spikes, MD
KER-012-A021 (TROPOS)
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension
- Enrollment Status: Recruiting
- Study Type: Interventional
- Intervention/Treatment: KER-012 or Placebo
- Sponsor: Keros Therapeutics
- PI: Leslie A. Spikes, MD
MK5475-013
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension
- Enrollment Status: Recruiting
- Study Type: Interventional
- Intervention/Treatment: MK-5475 or Placebo
- Sponsor: Merck Sharp & Dohme LLC
- PI: Leslie A. Spikes, MD
PBI-L606p3
A Phase 3, 2-Part, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects with Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated with Interstitial Lung Disease
- Enrollment Status: Recruiting
- Study Type: Interventional
- Intervention/Treatment: L606 (liposomal Treprostinil inhalation suspension
- Sponsor: Liquidia Technologies, Inc.
- PI: Leslie A. Spikes, MD
LTI-302 - INSPIRE OLE
A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients
- Enrollment Status: Active, Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: LIQ861
- Sponsor: Liquidia
- PI: Leslie A. Spikes, MD
MK-5475 - INSIGNIA-PAH
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: MK5475 or Placebo
- Sponsor: Merck & Co.
- PI: Leslie A. Spikes, MD
RiOciguAt UseRs Registry-The ROAR Registry
- Enrollment Status: Recruiting
- Study Type: Observational
- Intervention/Treatment: Riociguat (Adempas, BAY63-2521)
- Sponsor: Bayer
- PI: Leslie A. Spikes, MD
RT234-PAH-CL202
A Phase 2, Open-label, Dose Escalation Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects with Pulmonary Arterial Hypertension (PAH)
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Drug - RT234 - Vardenafil Inhalation Powder (PRN); Device - Axillary Oscillating Sphere Dry Powder Inhaler (AOS DPI)
- Sponsor: Respira Therapeutics
- PI: Leslie A. Spikes, MD
PHAR - Pulmonary Hypertension Association Registry
- Enrollment Status: Recruiting
- Study Type: Observational
- Sponsor: Pulmonary Hypertension Association, Inc.
- PI: Timothy Williamson, MD
XPOSE-PAH
Exposure to Substances in PAH (XPOSE-PAH)
- Enrollment Status: Recruiting
- Study Type: Case-control and prospective cohort study
- Sponsor: Pulmonary Hypertension Association, Inc.
- PI: Timothy Williamson, MD
Investigator-Initiated (Pulmonary Hypertension)
PHBR - Pulmonary Hypertension Biorepository & Registry
- Enrollment Status: Open to Enrollment
- Study Type: Observational
- Sponsor: University of Kansas Medical Center
- PI: Leslie A. Spikes, MD