Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-02 @ 8:22 PM
Study NCT ID:
NCT06570434
Status:
WITHDRAWN
Last Update Posted:
2024-10-16
First Post:
2024-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1b/2a in SLE With Budoputug
Sponsor:
Tenet Medicines
Organization:
Study Overview
Official Title:
A Phase 1b/2a 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WITHDRAWN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:
False
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 1b/2a, 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 Clinics(SLICC) classification criteria for SLE, and who have active SLE (as defined by a SLEDAI ≥ 4 at Screening and Day 1),have 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 Clinics(SLICC) classification criteria for SLE, and who have active SLE (as defined by a SLEDAI ≥ 4 at Screening and Day 1),have 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:
True
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?: