What is the mechanism of action of this treatment?

Common treatments for peanut allergy, such as oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and epicutaneous immunotherapy (EPIT), work by gradually exposing patients to small, controlled amounts of peanut protein. This exposure aims to desensitize the immune system, reducing its overreaction to peanut allergens. OIT involves ingesting peanut protein, SLIT places it under the tongue, and EPIT uses a skin patch. These mechanisms are crucial for peanut allergy patients as they can potentially increase the threshold of allergen required to trigger a reaction, thereby improving safety and quality of life by reducing the risk of severe allergic responses.

What side effects are associated with this type of intervention?

Common treatments for peanut allergy, such as oral immunotherapy (OIT) and epicutaneous immunotherapy (EPIT), are associated with several side effects. OIT often leads to allergic reactions, including anaphylaxis, vomiting, angioedema, and respiratory issues, with a higher incidence of these reactions compared to avoidance strategies. EPIT primarily causes local skin reactions, though serious adverse events are rare. Adjunct therapies like omalizumab and dupilumab, used in combination with OIT, have shown promise in reducing the frequency and severity of allergic reactions, but they still carry risks of mild to moderate adverse events.

What prior FDA approvals exist?

The FDA has approved Palforzia, an oral immunotherapy (OIT) for peanut allergy, which helps desensitize patients to peanut protein. Additionally, omalizumab, an anti-IgE monoclonal antibody, has been used off-label to reduce allergic reactions during OIT. These treatments aim to increase the threshold of peanut protein that triggers allergic reactions, similar to the goals of the CNP-201 trial.

What other types of research exist?

Promising novel alternatives for peanut allergy treatment in 2024 may include oral immunotherapy (OIT) with peanut protein, epicutaneous immunotherapy (EPIT) using peanut patches, and biologics such as anti-IgE antibodies (e.g., omalizumab). These approaches aim to desensitize patients to peanut allergens and reduce the severity of allergic reactions.

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Other

CNP-201 for Peanut Allergy

Phase 1

Waitlist Available

Research Sponsored by COUR Pharmaceutical Development Company, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1 pre-dose) through day 60, an average of 52 days

Awards & highlights

Summary

This trial tests a new treatment called CNP-201 to see if it is safe and how it affects the body. It includes people who meet specific health criteria. The treatment is given through an IV infusion, and researchers will monitor its safety and effects.

Who is the study for?

This trial is for men and women aged 16-55 with a physician-diagnosed peanut allergy or documented history of it. They must weigh at least 31.25 kg, have been on a peanut-free diet for at least 14 days prior to screening, and agree to avoid peanuts during the study. Participants need a specific level of peanut-specific IgE or positive skin test results for peanuts. Women can't be pregnant or breastfeeding, and all participants must use effective contraception.

What is being tested?

The trial is testing CNP-201 against a placebo in people with peanut allergies over multiple doses to find a safe amount that's tolerable. It has two phases: an Escalation Phase to determine the right dose levels, followed by an Expansion Phase where these levels are tested on more subjects.

What are the potential side effects?

Potential side effects aren't detailed here but generally could include reactions typical of new medications such as discomfort at injection site, allergic reactions, gastrointestinal issues like nausea or diarrhea, headaches, fatigue, or other immune-related responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1 pre-dose) through day 60, an average of 52 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1 pre-dose) through day 60, an average of 52 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1 pre-dose) through day 60, an average of 52 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

Secondary study objectives

Change in peanut specific IgE between CNP-201 and Placebo

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

Regulatory T-Lymphocytes

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: CNP-201 8 mgExperimental Treatment1 Intervention

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

Group II: CNP-201 4 mgExperimental Treatment1 Intervention

intravenous infusion on Day 1 and Day 8: 4 mg CNP-201

Group III: CNP-201 2 mgExperimental Treatment1 Intervention

intravenous infusion on Day 1 and Day 8: 2 mg CNP-201

Group IV: CNP-201 1 mgExperimental Treatment1 Intervention

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

Group V: PlaceboPlacebo Group2 Interventions

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for peanut allergy, such as oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and epicutaneous immunotherapy (EPIT), work by gradually exposing patients to small, controlled amounts of peanut protein. This exposure aims to desensitize the immune system, reducing its overreaction to peanut allergens. OIT involves ingesting peanut protein, SLIT places it under the tongue, and EPIT uses a skin patch. These mechanisms are crucial for peanut allergy patients as they can potentially increase the threshold of allergen required to trigger a reaction, thereby improving safety and quality of life by reducing the risk of severe allergic responses.

Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.[INVESTIGATION OF TREATMENT GOAL IN ALLERGEN IMMUNOTHERAPY FOR JAPANESE CEDAR POLLINOSIS].Enhancing the Safety and Efficacy of Food Allergy Immunotherapy: a Review of Adjunctive Therapies.

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Who is running the clinical trial?

COUR Pharmaceutical Development Company, Inc.Lead Sponsor

4 Previous Clinical Trials

128 Total Patients Enrolled

Jerry StaserStudy DirectorCOUR Pharmaceuticals

1 Previous Clinical Trials

9 Total Patients Enrolled

Greta Wodarcyk, PhDStudy DirectorCOUR Pharmaceuticals

Media Library

CNP-201 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05250856 — Phase 1

Peanut Allergy Research Study Groups: CNP-201 1 mg, CNP-201 2 mg, CNP-201 4 mg, CNP-201 8 mg, Placebo

Peanut Allergy Clinical Trial 2023: CNP-201 Highlights & Side Effects. Trial Name: NCT05250856 — Phase 1

CNP-201 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05250856 — Phase 1

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