- Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH) — Recruiting • Phase II • Cardiology / Cardiovascular • NCT07318597.
- Drug being tested: REGN13335, an experimental therapeutic agent, is being evaluated for safety and efficacy in adults with pulmonary arterial hypertension (PAH), a condition characterised by elevated pulmonary vascular resistance and right heart strain.
- Patient eligibility: The trial enrolls adult participants with confirmed PAH diagnosis; specific inclusion criteria regarding disease severity, current treatment status, and functional capacity are applied to define the study population.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines. The study is looking at several other research questions, including: * What side effects may happen from taking REGN13335 * How much REGN13335 is in the blood at different times * Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could…
- Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol 4. PVR ≥400 dynes∙sec/cm^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period 5. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.