Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570434
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Phase 1b2a in SLE With Budoputug
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b2a Open Label Dose Escalating Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Budoprutug in Adult Participants With Sys-temic Lupus Erythematosus SLE
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the safety tolerability and pharmacokinetics of budoprutug in participants with SLE
Detailed Description:
This is a Phase 1b2a multicenter open-label study designed to evaluate the safety tolerability PK and PD of budoprutug in adult participants with SLE
In Phase 1b participants who fulfill the 2012 Systemic Lupus International Collaborating ClinicsSLICC classification criteria for SLE and who have active SLE as defined by a SLEDAI 4 at Screening and Day 1have failed at least 1 line of treatment and who are assessed as appropriate for the study by the Eligibility Adjudicator will be enrolled in sequential escalating dose cohorts Three dose cohorts are planned
The Phase 2a expansion cohort will include approximately 16 to 20 participants with active SLE at least one-half of whom will have renal involvement Participants will continue to be followed through Week 52 for safety PK and PD assessmentsParticipants will also be monitored during this time for ongoing clinical response safety parameters and kinetics of re-population of B-cell subsets after the return of B cells to baseline values
In Phase 1b participants who fulfill the 2012 Systemic Lupus International Collaborating ClinicsSLICC classification criteria for SLE and who have active SLE as defined by a SLEDAI 4 at Screening and Day 1have failed at least 1 line of treatment and who are assessed as appropriate for the study by the Eligibility Adjudicator will be enrolled in sequential escalating dose cohorts Three dose cohorts are planned
The Phase 2a expansion cohort will include approximately 16 to 20 participants with active SLE at least one-half of whom will have renal involvement Participants will continue to be followed through Week 52 for safety PK and PD assessmentsParticipants will also be monitored during this time for ongoing clinical response safety parameters and kinetics of re-population of B-cell subsets after the return of B cells to baseline values
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None