PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03449524
• Date of registration: 14/02/2018
• Prospective Registration: Yes
• Primary sponsor: Complexa, Inc.
• Public title: PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) PAH
• Scientific title: Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
• Date of first enrolment: August 1, 2018
• Target sample size: 69
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03449524
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United Kingdom, United States

Contacts

• Name: Theo Danoff, MD
• Affiliation: Complexa, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females between 18 to 80 years of age inclusive at Screening

- Weight =40 kg

- Must have a diagnosis of WHO Group 1 PH

- Have a World Health Organization (WHO) Classification of Functional Status Class II or
III of patients with PH

- Must meet hemodynamic criteria by means of a right heart catheterization

- Meet pulmonary function test parameters

- A 6 MWD test of =125m and =550m at the visit

- Subjects must have a resting arterial oxygen saturation (SaO2) =90%, with or without
supplemental oxygen, as measured by pulse oximetry at Screening

- Subjects enrolled in a prescribed exercise program for pulmonary rehabilitation must
be in a stable program for 3 months prior to Screening (Visit 1) and must agree to
maintain their current level of rehabilitation throughout the study. If subjects are
not enrolled in a prescribed exercise training program for pulmonary rehabilitation,
they cannot enroll during the Screening/Baseline Period or throughout the study

- If receiving simvastatin-containing products: dose should not exceed 20 mg/day

- Subjects must be receiving no more than three of the following previously approved PAH
therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist
(ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor
agonists and must be on stable doses (=3 months) at Screening (Visit 1)

Exclusion Criteria:

- Contraindications for CMRI imaging

- WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension

- Unrepaired congenital heart defects and significant congenital heart defects (i.e.,
atrial septal defects, ventricular septal defects, and patent ductus arteriosus)
repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of
Pulmonary Hypertension)

- QTcF > 500 msec

- Acute myocardial infarction or acute coronary syndrome within the last 90 days

- Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days

- Hospitalization for left heart failure within the last 90 days

- Clinically significant aortic or mitral valve disease defined as greater than mild
regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive
cardiomyopathy; left ventricular dysfunction (LVEF < 50%); left ventricular outflow
obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid
depletion

- Chronic atrial fibrillation and life-threatening cardiac arrhythmias

- Personal or family history of congenital prolonged QTc syndrome or sudden or sudden
unexpected death due to a cardiac reason

- Clinically significant anemia

- Severe hepatic impairment or active chronic hepatitis

- Receiving intravenous inotropes within 2 weeks prior to Screening

- History of angina pectoris or other condition that was treated with long or short
acting nitrates <12 weeks of Screening

- Received prednisone doses >15mg/day or changes in immunosuppressive medications < 12
weeks prior to Screening (Visit 1)

- Recent (within 1 year) history of abusing alcohol or illicit drugs.

- History of any primary malignancy, with no evidence of disease for at least 5 years

- Treatment with any investigational drug or device within 30 days or 5 half-lives



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

PAH

Intervention(s)

Drug: 75mg CXA-10

Drug: 150mg CXA-10

Other: Placebo

Primary Outcome(s)

Pulmonary Vascular Resistance (PVR) [Time Frame: 6 months]

Right Ventricular Ejection Fraction (RVEF) [Time Frame: 6 months]

Secondary Outcome(s)

6 Minute Walk Distance (6MWD) [Time Frame: 6 months]

Secondary ID(s)

CXA-10-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MicroConstants

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Cardiovascular Clinical Science Foundation

Innovative Analytics

Medpace, Inc.

Philips Healthcare