CNP-201 in Subjects With Peanut Allergy

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    58
  • sponsor
    COUR Pharmaceutical Development Company, Inc.
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Updated on 7 October 2022
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Summary

This study is a Phase 1b/2a randomized, double-blind, placebo-controlled 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).

Description

Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into the study. Subjects will be randomized on Day 1 in a 2:1 ratio 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, and tolerability during the 52-day Post-Dosing period. Subjects will return to the clinic on Day 38 for collection of immune safety labs and PD measurements.

On Day 60, subjects will return to the clinic for collection of immune safety labs, PD measurements and to undergo a Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) consisting of peanut and placebo (oat) challenges. The DBPCFC will be conducted with a study physician or staff trained to manage clinical emergencies present on site, with immediate access to emergency medications and equipment, and within close proximity to hospital emergency departments for rapid delivery of urgent care if needed.

An additional 120-day Post-Dosing period is optional. On Day 90 and Day 120, subjects may choose to return to the clinic for collection of immune safety labs, and PD measurements. Subjects may then return to the clinic for the end of study visit on Day 180 for a second DBPCFC consisting of peanut and placebo (oat) challenges, collection of safety labs, PD measurements, and final assessment of AEs and medication changes.

Details
Condition Peanut Allergy
Treatment Placebo, CNP-201
Clinical Study IdentifierNCT05250856
SponsorCOUR Pharmaceutical Development Company, Inc.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men and non-pregnant women, ages 16 to 55 years inclusive
Subjects with physician-diagnosed peanut allergy or documented history of peanut allergy. Note: If subject does not have documented history in their medical record but is reasonably suspected of having peanut allergy and is deemed to otherwise be a good candidate for this trial, the screen testing (peanut specific IgE, SPT, etc.) may be used to establish the peanut allergy and the PI may subsequently document the peanut allergy to fulfil this inclusion criterion
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 38\
Female subjects who agree to not breastfeed starting at initial Screening and continuing to Day 38
Female subjects who agree to not donate ova starting at initial Screening and continuing to Day 38
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 38

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 timeframe
Any live vaccine (other than intranasal Influenza) within 28 days prior to Screening
Any subunit vaccine within 14 days prior to Screening
Any planned vaccination prior to Day 15
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
Subjects with relative contraindication or inability to use epinephrine auto-injector
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 used the following drug(s) within 2 months prior to Screening
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
Systemic steroids, chemical mediator-isolation inhibitors, Th2 cytokine
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
inhibitors, thromboxane -blockers, angiotensin-converting enzyme inhibitors
and/or angiotensin-receptor blockers unless, in the investigator's opinion
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
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
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
action of CNP-201 as determined in consultation with the sponsor
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 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, generalized anxiety disorder, panic disorder/attacks, or subjects who have received drug(s) for the treatment of dementia
Subjects who use beta-agonists (within 12 hours), theophylline (within 12 hours), and cromolyn (within 12 hours) prior to SPTs
Subjects with severe or poorly controlled (resistant to appropriate medical intervention) atopic disease including atopic dermatitis, generalized eczema, allergic rhinitis and/or urticaria
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 (Appendix 3) 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 two 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 who have received an investigational therapy within 28 days or 5 half-lives
whichever is longer, prior to 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)
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