Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Recruiting
Phase 2Interventional Study
Pulmonary Arterial Hypertension (PAH)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
99 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults who have been diagnosed with a specific type of high blood pressure in the lungs and who are currently taking stable treatments for it. They should be experiencing mild to moderate limitations in their daily activities. However, people with certain heart or lung diseases, or anyone with a history of severe bleeding issues, won't be eligible to participate.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
* …
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)
Trial Locations
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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 f…
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
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