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Looking for participantsPhase2

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT07318597

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
REGN13335 (drug), Placebo (drug)
How long the study runs
Study runs about 28 months (dates as stated)
About the drug or intervention
REGN13335 — drug: Administered per the protocol · Placebo — drug: Administered per the protocol
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
99
Started
2026-05-06
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary arterial hypertension (pah)
  • • Phase2 - 99 participants
  • • This study is researching an experimental drug called REGN13335

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with pulmonary arterial hypertension (pah)

Where?

  • • Bath - Royal United Hospitals Bath NHS Foundation Trust
  • • London - Royal Free Hospital
  • • London - Imperial College Healthcare NHS Trust, Hammersmith Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

Pulmonary Arterial Hypertension (PAH)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on lung Hypertension (WSPH))
  • ✓WHO functional class II or III (slight to marked limitation of functional status due to PAH)
  • ✓Receiving background the usual treatment (SOC) therapy for PAH on a stable dose and regimen, as determined by the...
  • ✓PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
  • ✓Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol

Who cannot take part

  • ✗lung Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
  • ✗History of left-sided heart disease and/or clinically significant heart disease, as described in the protocol
  • ✗Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity \<0.7 and FEV1...
  • ✗Evidence of interstitial lung disease as defined in the protocol
  • ✗Evidence of chronic thromboembolic lung disease or acute lung embolism as described in the protocol
See the full 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

Where Is This Study? (3 UK sites)

Royal United Hospitals Bath NHS Foundation Trust

Bath BA1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London W12 0HS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09