Phase 2B Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old

NCT04122170 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PB2452-PT-CL-0003
• Study Type: interventional
• Target: 207
• Locations: 2 countries
• Sites: 15

Brief Summary

This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old. A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start.

  Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo

  Baseline (pre-dose) to 4 hours after the start of infusion

Study Arms (2)

Bentracimab (PB2452)

ACTIVE COMPARATOR

PB2452 18 g Intravenous Infusion over a 16 hour duration.

Drug: Ticagrelor Oral Tablet - Pre-Treatment; Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment; Drug: Bentracimab (PB2452) Infusion

Placebo

PLACEBO COMPARATOR

Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.

Drug: Ticagrelor Oral Tablet - Pre-Treatment; Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment; Drug: Placebo (0.9% Sodium chloride) infusion

Interventions

Ticagrelor Oral Tablet - Pre-Treatment DRUG

Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.

Bentracimab (PB2452); Placebo

Aspirin (ASA) Oral Tablet - Pre-Treatment DRUG

Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.

Bentracimab (PB2452); Placebo

Bentracimab (PB2452) Infusion DRUG

Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.

Bentracimab (PB2452)

Placebo (0.9% Sodium chloride) infusion DRUG

0.9% Sodium chloride Intravenous Infusion over a 16 hour duration

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject provides written or verbal informed consent (in-person or remotely) and agrees to comply with all protocol requirements throughout study participation.
• The subject is male or female between ≥50 and ≤80 years of age.
• The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥ 50 kg but ≤ 120 kg, inclusive, at screening.

You may not qualify if:

• Subjects taking medications for well-controlled medical conditions must have been on a stable dose for at least 30 days prior to screening visit.
• Subjects entering the study must be willing to start and/or document an 81 mg daily dose of aspirin on Day -7 and must document daily dosing until the final dose is administered on the morning of Day 1. Subjects already taking daily aspirin must suspend aspirin dosing after Day 1 until discharge from the clinical facility.
• Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant for 3 months after the last dose of study drug. Female subjects of childbearing potential must use two effective methods of birth control from screening and before study drug administration through to the end of the study.
• In the opinion of the Investigator there are concern(s) regarding the inability of the subject to comply with study procedures and/or follow up, or, if the subject is not suitable for entry into the study.
• History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject to an extent where the subject's study participation is affected.
• Any clinically significant acute illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study drug or any planned surgical procedure that will occur during the study.
• Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in.
• Any specific contraindication to ticagrelor as described in the ticagrelor prescribing information.
• Receiving chronic treatment with nonsteroidal anti-inflammatory drugs \[including aspirin (\>100 mg daily), anticoagulants, or other antiplatelet agents that cannot be discontinued 14 days prior to screening including clopidogrel, prasugrel, ticlopidine, dipyridamole, or cilostazol\].
• First positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
• Has received another investigational drug within 30 days of the administration of study drug in this study or within 5 half-lives of the experimental medication, whichever is longer.
• History of severe or ongoing allergy/hypersensitivity to any biologic therapeutic agent.
• Involvement with any PhaseBio or study site employee or their close relatives (e.g., spouse, parents, siblings, or children whether biological or legally adopted).
• Previously received Bentracimab (PB2452) or had been randomized to receive study drug in an earlier cohort for this study

Sponsors & Collaborators

• SFJ Pharmaceuticals, Inc.: lead

Study Sites (15)

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014-3616, United States

Location

PPD Development, LP

Orlando, Florida, 32806, United States

Location

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

Location

BioPharma Services USA Inc. (BPSUSA)

St Louis, Missouri, 63141, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

VitaLink Research - Greenville

Greenville, South Carolina, 29615, United States

Location

VitaLink Research - Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Rebecca Wood-Horrall

Austin, Texas, 78744, United States

Location

BioPharma Services Inc.

Toronto, Ontario, M9L 3A2, Canada

Location

Altasciences Company Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

Aspirin; PB-2452; Sodium Chloride

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Michele LaRussa SVP, Chief Regulatory Officer
• Organization: SFJ Pharmaceuticals, Inc.

Bentracimab.General@SFJ-Pharma.com

925-223-6233

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 10, 2019
• Study Start: September 24, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); CA (2)