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Immunotherapy

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 and at visit 11 (day 60 post-dose)
Awards & highlights

Study Summary

This study is evaluating whether a drug called CNP-201 is safe and tolerable.

Eligible Conditions
  • Peanut Allergy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at visit 11 (day 60 post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at visit 11 (day 60 post-dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the proportion of activated peanut specific T cells (activated peanut specific T cells / total peanut specific T cells)
Change in the proportion of peanut specific Th2a+ T cells (peanut specific Th2a+ cells / total peanut specific T cells)
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
+1 more
Secondary outcome measures
Change in the ratio of IL-5 to IFN-γ
Other outcome measures
Change in the cumulative tolerated dose (CTD) of peanut protein (mg)
Change in the effective concentration at 50% of maximal basophil activation (EC50)
Change in the proportion of peanut specific T regulatory cells (peanut specific T regulatory cells / peanut specific CD4+ effector memory cells
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: CNP-201 650 mgExperimental Treatment1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: 650 mg CNP-201
Group II: CNP-201 450 mgExperimental Treatment1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: 450 mg CNP-201
Group III: CNP-201 250 mgExperimental Treatment1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: 250 mg CNP-201
Group IV: PlaceboPlacebo Group1 Intervention
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
134 Total Patients Enrolled
Jerry StaserStudy DirectorCOUR Pharmaceuticals, Inc
1 Previous Clinical Trials
15 Total Patients Enrolled
Robbin FrnkaStudy DirectorCOUR Pharmaceuticals
1 Previous Clinical Trials
15 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy
2021. "Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04950504.
~2 spots leftby Apr 2025
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