REGN13335 for adults with pulmonary arterial hypertension (PAH)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives adults with WHO functional class II–III PAH either REGN13335 or placebo in addition to their stable background PAH therapy to test safety and potential benefit. The study tracks side effects, measures drug levels in blood over time, and looks for anti-drug antibodies that could affect effectiveness or cause reactions. Key eligibility includes confirmed Group 1 PAH with PVR ≥400 dynes·sec/cm5 by right heart catheterization and a 6-minute walk distance between 150 and 550 meters. The trial is sponsored by Regeneron and is conducted at academic centers in the United States, United Kingdom, and South Korea.

Why it matters

Who can join: the full rules

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 Exclusion Criteria:

1. Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and/or multifactorial mechanisms) PH according to the 7th WSPH
2. Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
3. History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
4. Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity \<0.7 and FEV1 \<70% of the predicted value as described in the protocol
5. Evidence of interstitial lung disease as defined in the protocol
6. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
7. Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
8. Has any history of intracranial bleeding or any history of elevated intracranial pressure
9. Has any history of bleeding meeting criteria as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where it's running

• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Nebraska Medical Center - 2365
  Omaha, Nebraska, United States Recruiting
• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting
• The Prince Charles Hospital
  Brisbane, Queensland, Australia Recruiting
• Mater Misericordiae Ltd
  South Brisbane, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes

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• Treprostinil inhalation powder for PAH patients switching from selexipag

  This study tests whether inhaled treprostinil (LIQ861) is safe and tolerable for adults with PAH who are moving from oral selexipag to inhaled therapy.

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• Escalation options for PAH patients already on dual therapy

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• Vasoactive Agents in Pulmonary Hypertension Crisis

  This trial tests whether dopamine, norepinephrine, or epinephrine can safely and effectively help people with a pulmonary hypertension crisis who are in the hospital.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.