REGENERON PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF REGN13335

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OFREGN13335, AN ANTI-PDGF-B MONOCLONAL ANTIBODY, IN ADULTSWITH PULMONARY ARTERIAL HYPERTENSION

medical-cross
Pulmonary arterial hypertension (PAH), Pulmonary conditions
user
All genders
person-wave 18-100
world
Recruiting now

Overview
Principal Investigator: Nicholas Hill, MD

R13335-PAH-2365 is a phase 2, multinational, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study. The purpose of this study is to assess the efficacy, safety, PD, and PK of REGN13335 in participants with PAH. The study population will include adult participants with symptomatic PAH classified as World Health Organization (WHO) functional class II or III on stable background standard of care (SOC) therapy for PAH. Participants should remain on stable background SOC therapy for PAH for the duration of the study.

Study details
Inclusion Criteria
  • Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension)
  • PVR ≥400 dynes∙sec/cm5 (5 Wood units) based on right heart catheterization (RHC) during the screening period
  • 6MWD ≥150 and ≤550 meters during the screening period
Exclusion Criteria
  • Pulmonary arterial wedge pressure >15 mm Hg by RHC during the screening period
  • Obstructive lung disease defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity <0.7 and FEV1 <70% of the predicted value within 6 months prior to first screening visit or during the screening period
  • Evidence of interstitial lung disease within 6 months prior to first screening visit or during the
    screening period
Study Requirements

Subjects will be in this study minimum of 9 months and up to 2.5 years. Subjects will come to the site   8 or 9 times during the study treatment period. The visits will be every other week for the first month (some participants will have an extra visit in the first month) and then every 4 weeks. Over the course of the study, about 7 milliliters (2 teaspoons) to 39 milliliters (8 teaspoons) of blood will be taken at each visit that has blood draws. There may be a V/Q scan and/or an HRCT during the screening period.