Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04950504
Status:
TERMINATED
Last Update Posted:
2023-09-18
First Post:
2021-06-03
Brief Title:
Evaluate the Safety Tolerability Pharmacodynamics and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy
Sponsor:
COUR Pharmaceutical Development Company Inc
Organization:
COUR Pharmaceutical Development Company Inc
Study Overview
Official Title:
A Two-Part 1b2a Randomized Double Blind Placebo Controlled Study to Evaluate the Safety Tolerability Pharmacodynamics and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lagging Enrollment Opened a separate study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a two-part Phase 1b2a 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
Detailed Description:
Subjects who meet all inclusion and no exclusion criteria after initial screening assessments will undergo a Skin Prick Test SPT followed by a baseline Double-Blind Placebo-Controlled Food Challenge DBPCFC consisting of peanut and placebo oat challenges administered on two separate days to confirm an allergy to peanut Subjects who continue to meet all inclusion and no exclusion criteria after completing both days of the DBPCFC will be enrolled into the study
To mitigate the risk of anaphylaxis ahead of administering CNP-201 all Subjects who continue to meet all inclusion and no exclusion criteria following the DBPCFC will receive subcutaneous injections of omalizumab XOLAIR The dose of omalizumab XOLAIR will follow the product label specified in the protocol and will be determined by the subjects serum IgE at Screening and weight measured at the XOLAIR Dose 1 visit Subjects will be dosed either every 2 weeks or every 4 weeks according to the product label
Subjects who continue to meet all inclusion and no exclusion criteria will be randomized on Day 1 in a 21 ratio Part A or 11 ratio Part B to receive either CNP-201 or Placebo 09 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 pharmacodynamics and immunogenicity during the Post-Dosing period
To mitigate the risk of anaphylaxis ahead of administering CNP-201 all Subjects who continue to meet all inclusion and no exclusion criteria following the DBPCFC will receive subcutaneous injections of omalizumab XOLAIR The dose of omalizumab XOLAIR will follow the product label specified in the protocol and will be determined by the subjects serum IgE at Screening and weight measured at the XOLAIR Dose 1 visit Subjects will be dosed either every 2 weeks or every 4 weeks according to the product label
Subjects who continue to meet all inclusion and no exclusion criteria will be randomized on Day 1 in a 21 ratio Part A or 11 ratio Part B to receive either CNP-201 or Placebo 09 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 pharmacodynamics and immunogenicity during the Post-Dosing period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None