CNP-201 in Subjects With Peanut Allergy

NCT05250856 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CNP-201-5.002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 17

Brief Summary

This study is a Phase 1b/2a clinical trial to assess the safety, tolerability, and pharmacodynamics of multiple ascending doses (Escalation Phase) of CNP-201 with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects (Expansion Phase).

Conditions

Peanut Allergy

Keywords

Allergy; Food Allergy

Outcome Measures

Primary Outcomes (2)

• Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinuation from TP and study, by severity, and by causality. No formal statistical testing will be done.

  through Study Completion, an average of 67 Days

• Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)

  Summary statistics will be presented for the change from baseline values for Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)

  Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days

Secondary Outcomes (6)

• Change in the ratio of peanut specific IgE to IgG

  Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days

• Change in peanut specific IgE between CNP-201 and Placebo

  Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days

• Difference in percentage of subjects who pass a DBPCFC

  At Day 60

• Change in the proportion of peanut specific Th2a+ T cells

  Baseline (Day 1 pre-dose) through Day 15, an average of 15 Days

• Change in the effective concentration at 50% of maximal basophil activation (EC50)

  Baseline (Day 1 pre-dose), at Day 15, and at Day 60

Study Arms (5)

CNP-201 1 mg

EXPERIMENTAL

intravenous infusion on Day 1 and Day 8: 1 mg CNP-201

Drug: CNP-201

CNP-201 2 mg

EXPERIMENTAL

intravenous infusion on Day 1 and Day 8: 2 mg CNP-201

Drug: CNP-201

CNP-201 4 mg

EXPERIMENTAL

intravenous infusion on Day 1 and Day 8: 4 mg CNP-201

Drug: CNP-201

CNP-201 8 mg

EXPERIMENTAL

intravenous infusion on Day 1 and Day 8: 8 mg CNP-201

Drug: CNP-201

Placebo

PLACEBO COMPARATOR

200 ml intravenous infusion on Day 1 and Day 8: CNP-201 Placebo

Drug: CNP-201; Drug: Placebo

Interventions

CNP-201 DRUG

CNP-201 is comprised of purified peanut extract (PPE) drug substance dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of \~5 μg of PPE per mg of PLGA.

CNP-201 1 mg; CNP-201 2 mg; CNP-201 4 mg; CNP-201 8 mg; Placebo

Placebo DRUG

Placebo, (0.9% Sodium Chloride for IV infusion)

Placebo

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Men and non-pregnant women, ages 16 to 55 years inclusive.
• Subjects with weight ≥ 31.25 kg at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator.
• Subjects with a documented history of non-severe anaphylaxis (Grade ≤ 3) to peanuts, including mild wheezing or dyspnea without hypoxia.
• Subjects with peanut specific IgE \> 5 kU/L as measured by ImmunoCAP at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have peanut specific IgE ≥ 5 kU/L as measured by ImmunoCAP at Screening may be included at the discretion of the investigator, OR Subjects with a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm as compared to a negative control (50% glycerin) at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm at Screening may be included at the discretion of the investigator.
• Subjects who are self-reported to be on a peanut free diet with no suspected peanut exposure, including any peanut food challenge, for at least 14 days prior to Screening and agreement to continue restriction to peanut exposure during the study.
• Female subjects and male subjects and their female spouse/partners who are willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) starting at Screening and continuing to Day 60.
• Female subjects who agree to not breastfeed starting at initial Screening and continuing to Day 60.
• Female subjects who agree to not donate ova starting at initial Screening and continuing to Day 60.
• Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent.
• Subjects who are willing to perform and comply with all study procedures.
• Male subjects who agree to not donate sperm starting at Screening and continuing to Day 60.

You may not qualify if:

• Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation.
• Subjects with peanut specific IgE ≥ 100 kU/L as measured by ImmunoCAP at Screening.
• Subjects who have received administration of vaccinations in the following timeframe:
• Any live vaccine (other than intranasal Influenza) within 28 days prior to Screening.
• Any subunit vaccine within 14 days prior to Screening.
• Any COVID-19 vaccine within 14 days prior to Screening. Subjects who have received the first dose of any COVID-19 vaccine may not screen for the study until 14 days following their last dose of the vaccine if applicable.
• Any planned vaccination prior to Day 15.
• Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals tolerating maintenance aeroallergen or venom immunotherapy at Screening can be enrolled.
• Subjects with relative contraindication or inability to use epinephrine auto-injector.
• Subjects who have used the following drug(s) within 2 months prior to Screening: Th2 cytokine inhibitors, thromboxane A2 synthesis inhibitors, thromboxane A2 receptor antagonists, β-blockers, angiotensin-converting enzyme inhibitors, and/or angiotensin-receptor blockers unless, in the investigator's opinion, the underlying condition being treated by the drug is well controlled and the drug dose and frequency is not expected to interfere with the mechanism of action of CNP-201 as determined in consultation with the sponsor.
• Subjects who have used biologics and/or immune modulators (including but not limited to anti-TNFα antibody and anti-IgE monoclonal antibody) within three months prior to Screening.
• Subjects with a history of allergic reactions such as anaphylactic shock, angioedema with airway constriction, or hypotension caused by food other than peanut and/or medical products.
• Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/ antibody as determined at Screening.
• Subjects who are immunocompromised, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternate days for 2 weeks or more within 6 months prior to Screening, any dose of corticosteroids within 30 days of Screening, or high dose inhaled corticosteroids \[\> 960 μg/day of beclomethasone dipropionate or equivalent\]) or other immunosuppressive agents.
• Subjects with a history of unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease, or any other chronic medical condition that which in the opinion of the investigator, would pose a significant health threat in the event of anaphylaxis/treatment of anaphylaxis.

Sponsors & Collaborators

• COUR Pharmaceutical Development Company, Inc.: lead

Study Sites (17)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Long Beach Clinical Trials, LLC

Long Beach, California, 90806, United States

Location

Southern California Research

Mission Viejo, California, 92691, United States

Location

Allergy & Asthma Medicaal Group and Research Center

San Diego, California, 60062, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sneeze, Wheeze and Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Meridian Clinical Research. LLC

Overland Park, Kansas, 66210, United States

Location

Institute for Asthma & Allergy

Chevy Chase, Maryland, 20815, United States

Location

Aventiv Research, Inc

Columbus, Ohio, 43213, United States

Location

Vital Prospects Clinica Research Institute

Tulsa, Oklahoma, 74136, United States

Location

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420, United States

Location

Allergy Partners of North Texas Research

Dallas, Texas, 75230, United States

Location

Pharmaceutical Research & Consulting, Inc

Dallas, Texas, 75231, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Tranquil Clinical and Research Consulting Services

Houston, Texas, 77598, United States

Location

Clinical Research Partners

Richmond, Virginia, 23226, United States

Location

Seattle Allergy & Asthma Research Institute

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Jerry Staser

  COUR Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was designed with multiple ascending doses of CNP-201 in a Dose Escalation Phase, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in a Dose Expansion Phase. However, the study was terminated for administrative reasons and lagging enrollment within the Dose Escalation Phase.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 22, 2022
• Study Start: March 14, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)