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CNP-201 in Subjects With Peanut Allergy

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Men and non-pregnant women, ages 16 to 55 years inclusive. 2. Subjects with physician-diagnosed peanut allergy or documented history of peanut allergy. 3. Subjects with weight ≥ 31.25 kg at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator. 4. Subjects with a documented history of non-severe anaphylaxis (Grade ≤ 3) to peanuts, including mild wheezing or dyspnea without hypoxia. 5. 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. 6. 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. 7. 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. 8. 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. 9. Female subjects who agree to not breastfeed starting at initial Screening and continuing to Day 38. 10. Female subjects who agree to not donate ova starting at initial Screening and continuing to Day 38.. 11. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent. 12. Subjects who are willing to perform and comply with all study procedures. 13. Male subjects who agree to not donate sperm starting at Screening and continuing to Day 38.

Exclusion Criteria:

1. Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation. 2. 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.
3. 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. 4. Any planned vaccination prior to Day 15. 5. Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals tolerating maintenance aeroallergen or venom immunotherapy at Screening can be enrolled. 6. Subjects with relative contraindication or inability to use epinephrine auto-injector. 7. Subjects who have used the following drug(s) within two 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. 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. 13. Subjects with active eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease. 14. Subjects with clinically significant abnormality on electrocardiogram (ECG) at Screening that, in the investigator's opinion, makes the subject unsuitable for study participation. 15. 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. 16. 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. 17. Subjects with severe or poorly controlled (resistant to appropriate medical intervention) atopic disease including atopic dermatitis, generalized eczema, allergic rhinitis and/or urticaria. 18. Subjects who use beta-agonists (within 12 hours), theophylline (within 12 hours), and cromolyn (within 12 hours) prior to SPTs. 19. 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.
20. Subjects who have received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening. 21. 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. 22. Subjects with a known sensitivity to any components of CNP-201 (PLGA, sucrose, mannitol, or sodium citrate).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05250856
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

COUR Pharmaceutical Development Company, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Greta Wodarcyk, PhD
Principal Investigator Affiliation COUR Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Additional Details

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 172-day Post-Dosing period (up to Study Day 180). 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. On Day 90 and Day 120, subjects will return to the clinic for collection of immune safety labs, and PD measurements. Subjects will 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.

Arms & Interventions

Arms

Experimental: CNP-201 25 mg

200 mL intravenous infusion on Day 1 and Day 8: 25 mg CNP-201

Experimental: CNP-201 TBD(1) mg

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

Experimental: CNP-201 TBD(2) mg

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

Placebo Comparator: Placebo

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

Interventions

Drug: - CNP-201

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.

Drug: - Placebo

CNP-201 Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Southern California Research, Mission Viejo, California

Status

Not yet recruiting

Address

Southern California Research

Mission Viejo, California, 92691

San Diego, California

Status

Not yet recruiting

Address

Allergy & Asthma Medicaal Group and Research Center

San Diego, California, 60062

Aventiv Research, Inc, Columbus, Ohio

Status

Recruiting

Address

Aventiv Research, Inc

Columbus, Ohio, 43213

Site Contact

Lexi Lindic

llindic@aventivresearch.com

888-552-2687

Tulsa, Oklahoma

Status

Recruiting

Address

Vital Prospects Clinica Research Institute

Tulsa, Oklahoma, 74136

Site Contact

Caitlin Sheppard, CPhT

caitlin.sheppard@aaicenter.net

888-552-2687

North Charleston, South Carolina

Status

Recruiting

Address

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420

Site Contact

Jenine Dennis

jdennis@nationalallergyandent.com

888-552-2687

Allergy Partners of North Texas Research, Dallas, Texas

Status

Not yet recruiting

Address

Allergy Partners of North Texas Research

Dallas, Texas, 75230

Dallas, Texas

Status

Recruiting

Address

Pharmaceutical Research & Consulting, Inc

Dallas, Texas, 75231

Site Contact

Katrina Goldie

katrina.goldie@daac-prc.com

888-552-2687

Western Sky Medical Research, El Paso, Texas

Status

Recruiting

Address

Western Sky Medical Research

El Paso, Texas, 79903

Site Contact

Laura Herrera, APRN, FNP-C

lherrera@westernskymed.com

888-552-2687

Houston, Texas

Status

Withdrawn

Address

Tranquil Clinical and Research Consulting Services

Houston, Texas, 77598

Clinical Research Partners, Richmond, Virginia

Status

Not yet recruiting

Address

Clinical Research Partners

Richmond, Virginia, 23226

Seattle, Washington

Status

Recruiting

Address

Seattle Allergy & Asthma Research Institute

Seattle, Washington, 98115

Site Contact

Joy Fernandez, BS, MA-C

jfernandez@seattleallergy.org

888-552-2687

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