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

  • STATUS
    Recruiting
  • End date
    Apr 6, 2023
  • participants needed
    48
  • sponsor
    COUR Pharmaceutical Development Company, Inc.
Updated on 6 April 2022

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.

Description

Subjects who meet all inclusion and no exclusion criteria after initial screening assessments will undergo a Skin Prick Test (SPT) followed by a baseline Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) consisting of peanut and placebo (oat) challenges, administered on two separate days to confirm an allergy to peanut. Subjects who continue to meet all inclusion and no exclusion criteria after completing both days of the DBPCFC will be enrolled into the study.

To mitigate the risk of anaphylaxis ahead of administering CNP-201, all Subjects who continue to meet all inclusion and no exclusion criteria following the DBPCFC will receive subcutaneous injections of omalizumab (XOLAIR). The dose of omalizumab (XOLAIR) will follow the product label specified in the protocol and will be determined by the subject's serum IgE at Screening and weight measured at the XOLAIR Dose 1 visit. Subjects will be dosed either every 2 weeks or every 4 weeks according to the product label.

Subjects who continue to meet all inclusion and no exclusion criteria will be randomized on Day 1 in a 2:1 ratio (Part A) or 1:1 ratio (Part B) to receive either CNP-201 or Placebo (0.9% Sodium Chloride USP) by intravenous (IV) infusion. Subjects will be administered CNP-201 or Placebo on Day 1 and on Day 8.

Subjects will remain in the clinic on Day 1 and Day 8 from the time of admission (prior to administration of CNP-201 or Placebo) through the final procedure conducted 4 hours post-dose that same day unless an infusion reaction, anaphylaxis, or other adverse event requires an extended duration of monitoring. Subjects will be discharged if safety parameters are acceptable to the investigator. Seven days after the second administration of CNP-201 or Placebo, subjects must return to the clinic for collection of safety labs, PD measurements, and assessment of AEs and medication changes.

Subjects will continue to be followed for safety, pharmacodynamics, and immunogenicity during the Post-Dosing period.

Details
Condition Peanut Allergy
Treatment Placebo, CNP-201
Clinical Study IdentifierNCT04950504
SponsorCOUR Pharmaceutical Development Company, Inc.
Last Modified on6 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
Male subjects who agree to not donate sperm starting at Screening and throughout the entire study to Day 90 (EOS/ET)

Exclusion Criteria

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
Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals tolerating maintenance aeroallergen or venom immunotherapy at Screening can be enrolled
epicutaneous immunotherapy [EPIT], sublingual immunotherapy [SLIT]
subcutaneous immunotherapy [SCIT], and oral immunotherapy [OIT]) in the 3
Subjects who have a severe hypersensitivity to omalizumab or any ingredient of omalizumab
months prior to Screening, or who plan to receive any of these treatments
Subjects with relative contraindication or inability to use epinephrine auto-injector
during the study period
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 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 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
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 active eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease
Subjects with clinically significant abnormality on electrocardiogram (ECG) at Screening that, in the investigator's opinion, makes the subject unsuitable for study participation
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 active malignancy, or history of malignancy or chemotherapy within the past 5 years other than history of localized or surgical removal of focal skin cancer, or cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy
Subjects with a mental condition such as schizophrenia, bipolar disorder, major depressive disorder, or subjects who have received drug(s) for the treatment of dementia
Subjects with severe or poorly controlled atopic disease including atopic dermatitis, generalized eczema, allergic rhinitis and/or urticaria
Subjects who are unable to discontinue oral antihistamines for at least 7 days prior to Screening and at least 7 days prior to the start of the Post-Dosing DBPCFC Challenge 1 and through the completion of each challenge
Subjects who use beta-agonists (within 12 hours), theophylline (within 12 hours), and cromolyn (within 12 hours) prior to SPTs/DBPCFCs
Subjects with severe or uncontrolled/difficult to control asthma/wheezing, defined by at least one of the following criteria
Global Initiative for Asthma (GINA) 2020: Personalized management to control symptoms and minimize future risk requiring treatment Steps 4 or 5 OR
Forced expiratory volume in 1 second (FEV1) < 80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only those able to reliable perform spirometry. If unable to do spirometry, PEF of > 80% is acceptable OR
One overnight admission to a hospital in the past year for asthma OR
Emergency room visit for asthma within 6 months prior to Screening OR
History of 2 or more systemic corticosteroid courses within 6 months of Screening or one course of systemic corticosteroids within 3 months of Screening to treat asthma/wheezing OR
Prior intubation/mechanical ventilation for asthma/wheezing
Subjects with dose-limiting reaction (based on CoFAR Grading Scale for Systemic Allergic Reactions; to any dose during placebo (oat) DBPCFC at Screening
Subjects with any condition which, in the investigator's opinion, makes the subject unsuitable for study participation: Past or current medical problems, history of other chronic diseases requiring therapy, findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study
Subjects with a known sensitivity to any components of CNP-201 (PLGA, sucrose, mannitol, or sodium citrate)
Subjects who have received an investigational therapy within 28 days or 5 half-lives
whichever is longer, prior to Screening
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