Pulmonary Arterial Hypertension (PAH)Phase 2ILLUMINATENCT07318597
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
A Phase 2 study testing REGN13335 in people with Pulmonary Arterial Hypertension (PAH), run by Regeneron Pharmaceuticals at 33 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- REGN13335
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 33 sitesin 10 countries
- Study dates
- 6 May 2026to 17 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
- WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- 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
- 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 join
- 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
- Pulmonary Arterial Wedge Pressure (PAWP) >15 mm Hg by RHC during the screening period
- History of left-sided heart disease and/or clinically significant cardiac 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 <70% of the predicted value as described in the protocol
- Evidence of interstitial lung disease as defined in the protocol
- Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
Show all 10Show fewer
- Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
- Has any history of intracranial bleeding or any history of elevated intracranial pressure
- Has any history of bleeding meeting criteria as described in the protocol
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
33 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 10 countries
Spain6 sites, 6 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, Catalonia, 08035
- Recruiting
Hospital Clinic, Barcelona
Barcelona, 08036
- Recruiting
University hospital 12 de octubre
Madrid, 28041
- Recruiting
Hospital Universitario Costa del Sol
Marbella, Malaga, 29603
- Recruiting
University Hospital Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario De Toledo
Toledo, 45007
South Korea5 sites, 5 recruiting
- Recruiting
Gachon University Gil Medical Center
Namdong-gu, Incheon, 21565
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital
Seoul, 03722
- Recruiting
Samsung Medical Center
Seoul, 06351
United States4 sites, 4 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
- Recruiting
University of Nebraska Medical Center - 2365
Omaha, Nebraska, 68198
Poland4 sites, 4 recruiting
- Recruiting
University Hospital in Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
- Recruiting
Gornoslaskie Centrum Medyczne, Prof. Leszek Giec, Sląski Uniwersytet Medyczny, Katowice
Katowice, 40-635
- Recruiting
Oddzial Kardiologiczny
Lodz, Łódź Voivodeship, 93487
- Recruiting
University Clinical Hospital in Poznan - Early Phase Unit
Poznan, Greater Poland Voivodeship, 61-848
Australia3 sites, 3 recruiting
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland, 4032
- Recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
- Recruiting
Mater Misericordiae Ltd
South Brisbane, Queensland, 4101
Germany3 sites, 3 recruiting
- Recruiting
Clinic of University Greifswald
Greifswald, 17485
- Recruiting
Universitatsklinikum Halle
Halle, Saxony-Anhalt, 06120
- Recruiting
Universitatsmedizin Mainz
Mainz, 55131
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
- Recruiting
Royal Free Hospital
London, NW3 2QG
- Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, W12 0HS
Belgium2 sites, 2 recruiting
- Recruiting
H.U.B. Erasme Hospital
Brussels, 1070
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
France2 sites, 2 recruiting
- Recruiting
Hopital Bicetre
Le Kremlin-Bicêtre, 94275
- Recruiting
Nouvel hopital civil
Strasbourg, 67091
Latvia1 site, 1 recruiting
- Recruiting
P. Stradins Clinical University hospital
Riga, LV1002
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension
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)
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- REGN13335, Placebo
- Keywords
- Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH), Elevated Pulmonary Vascular Resistance (PVR), World Health Organization (WHO) functional class II or III, Platelet-Derived Growth Factor-B (PDGF-B), REGN13335
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN13335Drug
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| DBTP-Arm1 | Experimental | Not described Receives: Drug: REGN13335 |
| DBTP-Arm2 | Experimental | Not described Receives: Drug: REGN13335 |
| DBTP-Arm3 | Placebo comparator | Not described Receives: Drug: Placebo |
| OLE-Arm1 | Experimental | Not described Receives: Drug: REGN13335 |
| OLE-Arm2 | Experimental | Not described Receives: Drug: REGN13335 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pulmonary Vascular Resistance (PVR)
Measured: At week 24
Secondary outcomes (10)
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Through end of study, up to approximately 2.5 years
Severity of TEAEs
Measured: Through end of study, up to approximately 2.5 years
Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations
Measured: At week 24
Change from baseline in mean pulmonary artery pressure
Measured: At week 24
Change from baseline in cardiac output
Measured: At week 24
Change from baseline in cardiac index
Measured: At week 24
Change from baseline in right atrial pressure
Measured: At week 24
Change from baseline in 6-Minute Walk Distance (6MWD)
Measured: At week 24
Concentrations of functional REGN13335 in plasma
Measured: Through end of study, up to approximately 2.5 years
Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma
Measured: Through end of study, up to approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start6 May 2026
- Primary completion27 Feb 2028 (estimated)
- Study completion17 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include: A Double-Blind Treatment Period (DBTP) and an Open-Label Extension (OLE) period for participants who choose to continue treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318597
- Sponsor's protocol ID
- R13335-PAH-2365
- Other IDs
- 2024-514754-79-00
- Acronym
- ILLUMINATE
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07318597
- Acronym / sponsor ID
- ILLUMINATE / R13335-PAH-2365
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH), Elevated Pulmonary Vascular Resistance (PVR), World Health Organization (WHO) functional class II or III, Platelet-Derived Growth Factor-B (PDGF-B), REGN13335
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 27 Feb 2028 (estimated)
- Study completion
- 17 Sep 2028 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- The study will include: A Double-Blind Treatment Period (DBTP) and an Open-Label Extension (OLE) period for participants who choose to continue treatment
| Arm | Type | Receives |
|---|---|---|
| DBTP-Arm1 | Experimental | Drug: REGN13335 |
| DBTP-Arm2 | Experimental | Drug: REGN13335 |
| DBTP-Arm3 | Placebo comparator | Drug: Placebo |
| OLE-Arm1 | Experimental | Drug: REGN13335 |
| OLE-Arm2 | Experimental | Drug: REGN13335 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
- WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- 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
- 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
Key exclusion criteria (10 listed)
- 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
- Pulmonary Arterial Wedge Pressure (PAWP) >15 mm Hg by RHC during the screening period
- History of left-sided heart disease and/or clinically significant cardiac 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 <70% of the predicted value as described in the protocol
- Evidence of interstitial lung disease as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN13335Administered per the protocol | Drug | DBTP-Arm1, DBTP-Arm2, OLE-Arm1, OLE-Arm2 |
| PlaceboAdministered per the protocol | Drug | DBTP-Arm3 |
Primary outcome
Change from baseline in Pulmonary Vascular Resistance (PVR)
Time frame: At week 24
10 secondary outcomes
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through end of study, up to approximately 2.5 years
Severity of TEAEs
Time frame: Through end of study, up to approximately 2.5 years
Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations
Time frame: At week 24
Change from baseline in mean pulmonary artery pressure
Time frame: At week 24
Change from baseline in cardiac output
Time frame: At week 24
Change from baseline in cardiac index
Time frame: At week 24
Change from baseline in right atrial pressure
Time frame: At week 24
Change from baseline in 6-Minute Walk Distance (6MWD)
Time frame: At week 24
Concentrations of functional REGN13335 in plasma
Time frame: Through end of study, up to approximately 2.5 years
Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma
Time frame: Through end of study, up to approximately 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- IlluminateLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGN13335 in people with Pulmonary Arterial Hypertension (PAH), run by Regeneron Pharmaceuticals at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, South Korea, United States, Poland, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pulmonary Vascular Resistance (PVR) (time frame: At week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.