Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05104853
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2021-10-22
Brief Title:
Study to Evaluate the Safety Tolerability PDs and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
Sponsor:
COUR Pharmaceutical Development Company Inc
Organization:
COUR Pharmaceutical Development Company Inc
Study Overview
Official Title:
A Phase 2a Double Blind Placebo Controlled Study to Evaluate the Safety Tolerability Pharmacodynamics and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA andor OCA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 Phase 2a First-in-Human FIH clinical trial to assess the safety tolerability pharmacodynamics PD and efficacy of multiple ascending doses of CNP-104 The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period
Detailed Description:
Subjects ages 18-75 with primary biliary cholangitis will be screened up to 14 days prior to enrollment into the study Screening will be completed to assess eligibility obtain vital signs collect laboratory samples and PD measurements and to receive a FibroScan for liver fibrosis Subjects will additionally complete an initial PBC-40 assessment and begin an Itch Diary a questionnaire and scoring system to be completed by the patient every morning and evening through Day 120 and then monthly through end of study
Subjects who meet all inclusion and no exclusion criteria after completing the screening visit will be enrolled in the study Subjects will be randomized on Day 1 in a 11 ratio to receive either CNP-104 or Placebo 09 Sodium Chloride USP by intravenous IV infusion Subjects will be administered CNP-104 or Placebo on Day 1 and on Day 8 This study was originally designed with 2 cohorts Cohort 1 comprised of 6 subjects randomized 11 to placebo or 4 mgkg and Cohort 2 comprised of up to 34 subjects randomized 11 to placebo or 8 mgkg Under Protocol Amendment 6 v70 the remaining subjects for Cohort 2 approximately 16 will be randomized 131 to placebo 4 mgkg and 8 mgkg respectively
Subjects will remain in the clinic on Day 1 and Day 8 from the time of admission prior to administration of CNP-104 or Placebo through the final procedure conducted 4 hours post-dose that same day unless an infusion reaction 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-104 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 2 years to assess safety pharmacodynamics and immunogenicity during the Post-Dosing period
Subjects who meet all inclusion and no exclusion criteria after completing the screening visit will be enrolled in the study Subjects will be randomized on Day 1 in a 11 ratio to receive either CNP-104 or Placebo 09 Sodium Chloride USP by intravenous IV infusion Subjects will be administered CNP-104 or Placebo on Day 1 and on Day 8 This study was originally designed with 2 cohorts Cohort 1 comprised of 6 subjects randomized 11 to placebo or 4 mgkg and Cohort 2 comprised of up to 34 subjects randomized 11 to placebo or 8 mgkg Under Protocol Amendment 6 v70 the remaining subjects for Cohort 2 approximately 16 will be randomized 131 to placebo 4 mgkg and 8 mgkg respectively
Subjects will remain in the clinic on Day 1 and Day 8 from the time of admission prior to administration of CNP-104 or Placebo through the final procedure conducted 4 hours post-dose that same day unless an infusion reaction 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-104 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 2 years to assess 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