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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID

NCT04950504

Run by

COUR Pharmaceutical Development Company, Inc.

People needed

9

Starts

2021-06-02

Expected to finish

2022-07-29

Last updated by the study team

2023-09-18

Who can join

Age: 16 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.
• 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 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, 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:

Where it is running

• Medical Research of Arizona — Scottsdale, Arizona, United States
• Stanford University School of Medicine / Sean N. Parker Center for Allergy and Asthma Research — Mountain View, California, United States
• Peninsula Research Institute — Rolling Hills Estates, California, United States
• Allergy & Asthma Medical Group and Research Center — San Diego, California, United States
• Allergy & Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States
• Pharmaceutical Research & Consulting, Inc — Dallas, Texas, United States
• Western Sky Medical Research — El Paso, Texas, United States
• Seattle Allergy & Asthma — Seattle, Washington, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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