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Current Pulmonary Hypertension Trials

Pharmaceutical Studies

A011-09 - PULSAR

A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

  • Enrollment Status: Active, Closed to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Sotatercept or Placebo
  • Sponsor: Acceleron Pharma
  • PI: Leslie A. Spikes, M.D.

A011-11 - STELLAR

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

  • Enrollment Status: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Sotatercept or Placebo
  • Sponsor: Acceleron Pharma
  • PI: Leslie A. Spikes, M.D.

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, M.D.

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: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Sotatercept or Placebo
  • Sponsor: Acceleron Pharma
  • PI: Leslie A. Spikes, M.D.

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: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Sotatercept or Placebo
  • Sponsor: Acceleron Pharma
  • PI: Leslie A. Spikes, M.D.

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: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Sotatercept or Placebo
  • Sponsor: Acceleron Pharma
  • PI: Leslie A. Spikes, M.D.

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: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: AV-101 or Placebo
  • Sponsor: Aerovate Therapeutics
  • PI: Leslie A. Spikes, M.D.

BIA-51058-203-UpRight

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase IIb Study with Open-Label Extension to Demonstrate the Efficacy and Safety of Zamicastat (BIA 5-1058) as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH) Patients with Right Ventricular (RV) Systolic Dysfunction. 

  • Enrollment Status: Open to Enrollment
  • Study Type: Interventional
  • Intervention/Treatment: BIA 5-1058 or Placebo
  • Sponsor: BIAL
  • PI: Leslie A. Spikes, M.D.

GB002-2101 - TORREY

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH).

  • Enrollment Status: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: GB002 or Placebo
  • Sponsor: Gossamer Bio
  • PI: Leslie A. Spikes, M.D.

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: Open to Enrollment upon successful completion of GB002-2101
  • Study Type: Interventional
  • Intervention/Treatment: GB002
  • Sponsor: Gossamer Bio
  • PI: Leslie A. Spikes, M.D.

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.


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, M.D.

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: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: MK5475 or Placebo
  • Sponsor: Merck & Co.
  • PI: Leslie A. Spikes, M.D.

PB1046-PT-CL-0004 - VIP

A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension

  • Enrollment Status: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Pemziviptadil (PB1046) or Placebo
  • Sponsor: PhaseBio
  • PI: Leslie A. Spikes, M.D.

PB1046-PT-CL-0006 - VIP EXTEND

A Long-Term, Open-label Extension Study of PB1046 Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004

  • Enrollment Status: Open to Enrollment upon successful completion of PB1046-PT-CL-0004
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Pemziviptadil (PB1046)
  • Sponsor: PhaseBio
  • PI: Leslie A. Spikes, M.D.

RiOciguAt UseRs Registry - The ROAR Registry


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)


RVT-1201-2002 - ELEVATE 2

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension

  • Enrollment Status: Open to Enrollment
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: Rodatristal Ethyl or Placebo
  • Sponsor: Altavant Sciences
  • PI: Leslie A. Spikes, M.D.

TIP-PH-101 - BREEZE

An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects with Pulmonary Arterial Hypertension Currently Using Tyvaso


PHAR - Pulmonary Hypertension Association Registry


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, M.D.
Internal Medicine

University of Kansas Medical Center
Internal Medicine
Pulmonary, Critical Care, and Sleep Medicine Division
Mailstop 3007
3901 Rainbow Boulevard
Kansas City, KS 66160
Phone: 913-588-6045