Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335979
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-22
Brief Title:
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus SLE
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase Ib Open-label Ascending Dose Study With Step-up Doses to Assess Safety Tolerability and Pharmacokinetics of PIT565 in Participants With Systemic Lupus Erythematosus SLE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of the study is to determine the safety tolerability and pharmacokinetics of PIT565 in participants with SLE
Detailed Description:
This is an open-label ascending dose uncontrolled study in participants with SLE systemic lupus erythematosus SLE PIT565 will be administered subcutaneously sc following premedication
Up to 8 cohorts are planned Every cohort will have 3 sentinel participants and depending on safety as well as observed biological activity may have up to 3 additional optional participants up to 6 participants per cohort The decision to escalate the dose from one cohort to the next will be based both on safety and PD data After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100 of the participants candidate dose level the cohort from this candidate dose level can optionally be enriched with 6 additional participants up to a total of 12 participants
Up to 8 cohorts are planned Every cohort will have 3 sentinel participants and depending on safety as well as observed biological activity may have up to 3 additional optional participants up to 6 participants per cohort The decision to escalate the dose from one cohort to the next will be based both on safety and PD data After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100 of the participants candidate dose level the cohort from this candidate dose level can optionally be enriched with 6 additional participants up to a total of 12 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510025-14-00 | OTHER | EU CT | None |