NCT07318597 Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
| NCT ID | NCT07318597 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Regeneron Pharmaceuticals |
| Condition | Pulmonary Arterial Hypertension (PAH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2028-02-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 99 participants in total. It began in 2026-05-06 with a primary completion date of 2028-02-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 lead to side effects)
Eligibility Criteria
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
Contact & Investigator
Clinical Trial Management
STUDY DIRECTOR
Regeneron Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07318597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension (PAH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07318597 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07318597 currently recruiting?
Yes, NCT07318597 is actively recruiting participants. Contact the research team at clinicaltrials@regeneron.com for enrollment information.
Where is the NCT07318597 trial being conducted?
This trial is being conducted at Aurora, United States, Boston, United States, South Brisbane, Australia, Hobart, Australia and 11 additional locations.
Who is sponsoring the NCT07318597 clinical trial?
NCT07318597 is sponsored by Regeneron Pharmaceuticals. The principal investigator is Clinical Trial Management at Regeneron Pharmaceuticals. The trial plans to enroll 99 participants.