A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)
Pulmonary Arterial Hypertension
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary arterial hypertension (PAH), Pulmonary hypertension (PH), RVT-1201, Rodatristat ethyl, Tryptophan hydroxylase (TPH), Serotonin reduction, ELEVATE 1, KAR5417
Eligibility Criteria
Key Inclusion Criteria:
Symptomatic PAH belonging to one of the following types:
- Idiopathic
- Heritable
- Drug- or toxin- induced
- Associated with one of the following: connective tissue disease or congenital heart disease
- World Health Organization (WHO) Functional Class (FC) II or III
- PAH diagnosed by right heart cardiac catheterization prior to Screening
- Receiving standard of care treatment for PAH with oral monotherapy or dual therapy for at least 12 weeks prior to Screening at a dose which has been stable for at least 8 weeks prior to Screening
- If on a diuretic, dose must be stable for at least 4 weeks prior to Screening, with no changes anticipated during study participation
- 6-Minute Walk Distance (6MWD) between 150 and 500 meters at Screening and Baseline visits
- Plasma N-terminal pro B-type natriuretic peptide (NT-proBNP) level ≥ 300 pg/mL at Screening
- Ability and willingness to give written informed consent and to comply with the requirements of the study
Key Exclusion Criteria:
- PAH associated with human immunodeficiency virus (HIV) infection, portal hypertension or schistosomiasis
Other types of pulmonary hypertension (PH):
- Pulmonary hypertension due to left heart disease (WHO PH Group 2)
- Pulmonary hypertension due to lung diseases and/or hypoxia (WHO PH Group 3)
- Chronic thromboembolic pulmonary hypertension (WHO PH Group 4)
- Pulmonary hypertension with unclear multifactorial mechanisms (WHO PH Group 5)
- Hospitalization for pulmonary hypertension within 12 weeks of screening
- Cardiopulmonary rehabilitation program based on exercise (planned, or started ≤ 12 weeks prior to Screening)
- Prostanoid or prostacyclin receptor agonist therapy within 12 weeks of screening
- Evidence of left-sided heart disease
- If Pulmonary function tests were done prior to screening, Pulmonary function tests demonstrate obstructive or restrictive lung disease
- Use of telotristat (Xermelo®) within the last 6 months
- Use of any investigational drug within 30 days or five half-lives (whichever is longer) prior to Screening, or 90 days if an investigational drug for PAH
- Have uncontrolled atrial fibrillation (AFib) or other uncontrolled arrhythmias
- Body mass index (BMI) >45 kg/m2
- Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception
Sites / Locations
- Pulmonary Associates, PA
- University of California Davis Medical Center
- SBPA Research LLC
- University of Colorado
- George Washington Medical Faculty Associates - Pulmonary Hypertension Program
- University of Florida
- San Marcus Research Clinic, Inc.
- Central Florida Pulmonary Group, P.A.
- University of Chicago Medical Center
- Kentuckiana Pulmonary Research Center
- Louisiana State University Health Sciences Center
- Boston Children's Hospital
- Baystate Medical Center
- Pulmonary Research Institute of Southeast Michigan
- Washington University School of Medicine
- Duke University Medical Center
- Cleveland Clinic
- Oregon Health & Science University
- University of Texas Southwestern Medical Center
- University of Texas Health Science Center at Houston, McGovern Medical School
- University of Calgary
- University of Alberta
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
RVT-1201
Placebo
RVT-1201 600 mg immediate-release tablet, administered orally twice daily with food for 6 weeks, in addition to the patient's current standard of care medication(s) for PAH (n=24 [Anticipated])
Matching placebo tablet, administered orally twice daily with food for 6 weeks, in addition to the patient's current standard of care medication(s) for PAH (n=12 [Anticipated])