A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03924154
• Date of registration: 05/04/2019
• Prospective Registration: Yes
• Primary sponsor: Altavant Sciences GmbH
• Public title: A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)
• Scientific title: A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: August 1, 2019
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03924154
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Ed Parsley, DO
• Affiliation: Altavant Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Placebo

Drug: RVT-1201

Primary Outcome(s)

Adverse events (AEs) and discontinuations due to AEs [Time Frame: 8 weeks]

Secondary Outcome(s)

Area under the plasma concentration versus time curve (AUC) of KAR5417 (the active metabolite of RVT-1201) [Time Frame: 6 weeks]

Concentration of biomarkers of serotonin biosynthesis in plasma [Time Frame: 8 weeks]

Concentration of biomarkers of serotonin biosynthesis in urine [Time Frame: 8 weeks]

Relationship between KAR5417 exposure and percent change from baseline in urine concentrations of the serotonin-related biomarkers [Time Frame: 6 weeks]

Study drug (RVT-1201) and active metabolite (KAR5417) plasma concentrations [Time Frame: 6 weeks]

Relationship between KAR5417 exposure and percent change from baseline in plasma concentrations of the serotonin-related biomarkers [Time Frame: 6 weeks]

Secondary ID(s)

RVT-1201-2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PPD

Altavant Sciences, Inc.