Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy

NCT04950504 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CNP-201-5.001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a two-part Phase 1b/2a First-in-Human (FIH) randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-201 in Part A, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in Part B.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (4)

• 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 90 Days

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

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

  through Study Completion, an average of 90 Days

• Change in the proportion of peanut specific Th2a+ T cells (peanut specific Th2a+ cells / total peanut specific T cells)

  Change in the proportion of peanut specific Th2a+ T cells (peanut specific Th2a+ cells / total peanut specific T cells) following ex vivo stimulation of PBMCs between placebo and CNP-201

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

• Change in the proportion of activated peanut specific T cells (activated peanut specific T cells / total peanut specific T cells)

  Change in the proportion of activated peanut specific T cells (activated peanut specific T cells / total peanut specific T cells) following ex vivo stimulation of PBMCs between placebo and CNP-201

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

Secondary Outcomes (1)

• Change in the ratio of IL-5 to IFN-γ

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

Other Outcomes (4)

• Change in the proportion of peanut specific T regulatory cells (peanut specific T regulatory cells / peanut specific CD4+ effector memory cells

  Baseline (Day 1 pre-dose) and at Day 15.

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

  Baseline and at Visit 11 (Day 60 Post-Dose)

• Change in the ratio of peanut specific IgE to IgG

  Baseline and at Visit 11 (Day 60 Post-Dose)

Study Arms (4)

CNP-201 250 mg

EXPERIMENTAL

200 mL intravenous infusion on Day 1 and Day 8: 250 mg CNP-201

Drug: CNP-201

CNP-201 450 mg

EXPERIMENTAL

200 mL intravenous infusion on Day 1 and Day 8: 450 mg CNP-201

Drug: CNP-201

CNP-201 650 mg

EXPERIMENTAL

200 mL intravenous infusion on Day 1 and Day 8: 650 mg CNP-201

Drug: CNP-201

Placebo

PLACEBO COMPARATOR

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

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-201 250 mg; CNP-201 450 mg; CNP-201 650 mg

Placebo DRUG

CNP-201 Placebo

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 35 years inclusive.
• Subjects with a Body Mass Index (BMI) ≥ 18 and ≤ 32 and weight \> 30 kg and ≤ 150 kg at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator.
• Subjects with serum IgE ≥ 30 IU/mL and ≤ 1500 IU/mL at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator.
• Subjects with physician-diagnosed peanut allergy or documented history of peanut allergy.
• 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 \> 2 kU/L as measured by ImmunoCAP at Screening and/or 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 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 with the exception of the study DBPCFCs.
• 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 throughout the entire study to Day 90 (EOS/ET).
• Female subjects who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 90 (EOS/ET).
• Female subjects who agree to not donate ova starting at initial Screening and throughout the entire study to Day 90 (EOS/ET).
• 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 including attending study visits as scheduled and completing two DBPCFCs.
• Male subjects who agree to not donate sperm starting at Screening and throughout the entire study to Day 90 (EOS/ET).
• Subjects must have a positive peanut DBPCFC at Screening with an eliciting dose of ≥ 10 mg and ≤ 300 mg of peanut protein in order to be included in statistical analyses for exploratory endpoints. Subjects who tolerate \> 444 mg of peanut protein (cumulative tolerated dose) will be followed for safety and will be evaluated separately.

You may not qualify if:

• Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation.
• Subjects who have received administration of vaccinations in the following time frame:
• 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 (either first or second dose) 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 second dose of the vaccine if applicable;
• Any planned vaccination prior to Day 15.
• Subjects who have received any specific immunotherapy for food allergy (e.g., epicutaneous immunotherapy \[EPIT\], sublingual immunotherapy \[SLIT\], subcutaneous immunotherapy \[SCIT\], and oral immunotherapy \[OIT\]) in the 3 months prior to Screening, or who plan to receive any of these treatments during the study period.
• Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals tolerating maintenance aeroallergen or venom immunotherapy at Screening can be enrolled.
• Subjects who have a severe hypersensitivity to omalizumab or any ingredient of omalizumab.
• 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: Systemic steroids, chemical mediator-isolation inhibitors, Th2 cytokine inhibitors, thromboxane A2 synthesis inhibitors, thromboxane A2 receptor antagonists, β-blockers, angiotensin-converting enzyme inhibitors, and/or angiotensin-receptor blockers.
• Subjects who have used biologics and/or immune modulators (including but not limited to anti-TNFα antibody and anti-IgE monoclonal antibody) within 3 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.

Sponsors & Collaborators

• COUR Pharmaceutical Development Company, Inc.: lead

Study Sites (9)

Medical Research of Arizona

Scottsdale, Arizona, 85251, United States

Location

Stanford University School of Medicine / Sean N. Parker Center for Allergy and Asthma Research

Mountain View, California, 94040, United States

Location

Peninsula Research Institute

Rolling Hills Estates, California, 90274, United States

Location

Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

Pharmaceutical Research & Consulting, Inc

Dallas, Texas, 75231, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Seattle Allergy & Asthma

Seattle, Washington, 98115, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98181, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jerry Staser

  COUR Pharmaceuticals, Inc

  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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was designed as a multiple ascending doses of CNP-201 in Part A, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in Part B. However, the study was terminated for administrative reasons prior to the completion of the first Cohort in Part A.

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: July 6, 2021
• Study Start: June 2, 2021
• Primary Completion: June 24, 2022
• Study Completion: July 29, 2022
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)