Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05879718
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-05-18
Brief Title:
A Study to Learn About the Study Medicine PF-06823859 in Adults With Active CLE or SLE With Skin Symptoms
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 2 DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT PHARMACODYNAMIC PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS
Status:
RECRUITING
Status Verified Date:
2024-10
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 this study is to learn about the effects safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus CLE or systemic lupus erythematosus SLE showing some skin symptoms
This study is seeking for participants who
are adults of 18 years of age or older
are confirmed to have CLE or SLE with involvement of the skin
have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity CLASI-A score of at least 8
About 48 participants will be selected to receive active study medicine PF-06823859 or placebo an infusion without drug About 32 are grouped to receive the active study medicine and 16 are to receive placebo They will be receiving the treatments by intravenous infusion injected directly into the veins
At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40 All participants will have last follow-up visit at Week 60
The study will compare participants receiving PF-06823859 to participants who receive placebo This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participants CLASI-A score Participants will take part in this study for about 65 weeks This includes up to a 5-week selection period a 12-week Q4Wk treatment period a 36-week Q8Wk treatment period and a 12-week follow-up period
This study is seeking for participants who
are adults of 18 years of age or older
are confirmed to have CLE or SLE with involvement of the skin
have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity CLASI-A score of at least 8
About 48 participants will be selected to receive active study medicine PF-06823859 or placebo an infusion without drug About 32 are grouped to receive the active study medicine and 16 are to receive placebo They will be receiving the treatments by intravenous infusion injected directly into the veins
At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40 All participants will have last follow-up visit at Week 60
The study will compare participants receiving PF-06823859 to participants who receive placebo This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participants CLASI-A score Participants will take part in this study for about 65 weeks This includes up to a 5-week selection period a 12-week Q4Wk treatment period a 36-week Q8Wk treatment period and a 12-week follow-up period
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503343-33-00 | REGISTRY | CTIS EU | None |