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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

Study Summary

This trial is testing a new drug to see if it is safe and effective.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to register for this research study?

"This medical trial is looking to enrol 58 individuals that suffer from peanut allergies, ranging in age between 16 and 55. Participants must meet the following criteria: Men and non-pregnant women of ages 16 - 55 years old, with a physician verified or documented history of allergy; evidence of anaphylaxis (Grade ≤ 3) due to peanuts including mild wheezing/dyspnea without hypoxia; ImmunoCAP score ≥ 5 kU/L at screening OR SPT change in diameter ≥ 3mm compared to negative control; female subjects willing to practice effective contraception from Screening until Day 38 as well as refrain"

Answered by AI

What is the principal aim of this experiment?

"Based on the information released by COUR Pharmaceutical Development Company, Inc., this study's primary metric of success is tracking frequency of adverse events and serious adverse events over an average period of 180 days. Other secondary objectives include measuring changes in peanut specific IgE to IgG ratio via ImmunoCap assay, basophil activation response as a result of CNP-201 & placebo treatment at baseline, Day 60, and Day 180; along with recording any change in peanut specific immunoglobulin E between CNP-201 & placebo groups from Baseline (Screening) to Visit 5."

Answered by AI

Is this research protocol permitting individuals aged thirty or over to participate?

"This study requires that the enrolled participants must fall between 16 to 55 years of age."

Answered by AI

At what venues is this experiment currently taking place?

"A total of 15 medical centres are offering this clinical trial, such as AllerVie Clinical Research in Birmingham, Southern California Research in Mission Viejo and Children's Research Institute in Washington. An additional 12 sites can be found throughout the country."

Answered by AI

How many participants has the research team recruited for this trial?

"This clinical trial seeks 58 volunteers that meet the pre-set inclusion criteria. Potential participants can locate study sites at AllerVie Clinical Research in Birmingham, Alabama and Southern California Research in Mission Viejo, District of Columbia."

Answered by AI

Is this research endeavor currently open to participants?

"According to the clinicaltrials.gov website, this research endeavour is presently seeking participants since its initial posting on March 14th 2022 and last revision on August 22nd 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CNP-201 in Subjects With Peanut Allergy
2022. "CNP-201 in Subjects With Peanut Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05250856.
~5 spots leftby Apr 2025
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