Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163326
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-11-30
Brief Title:
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 3 OPEN-LABEL MULTI-CENTER EXTENSION STUDY INVESTIGATING THE SAFETY EFFICACY AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
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:
Tranquillo LTE
Brief Summary:
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo NSV
Ritlecitinib is studied in patients with non-segmental vitiligo Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin
Non-segmental vitiligo is an autoimmune disorder and is the focus of this study The study will show
if the repigmentation the recovery of pigmentation achieved in study B7981040 also called the parent study will stay the same or will further increase if you keep receiving the same study medicine ritlecitinib 50 milligrams or placebo
Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study
This study is seeking for participants who
have non-segmental vitiligo either active or stable and
received ritlecitinib or placebo for 52 weeks in the parent study A placebo looks exactly like the study capsule but does not contain any medicine in it
All participants in this study will receive the study medicine or placebo The study medicine ritlecitinib 50 milligrams or 100 milligrams or placebo are capsules that are taken by mouth at home every day At week 4 or if it cannot be done then at week 8 study visit you must take the medication at the study site and not at home
Participants may receive the study medicine or placebo for up to 52 weeks
The study will look at the experiences of people receiving the study medicine This will help see if ritlecitinib is better for treating vitiligo
Participants will be involved in this study for a maximum of 60 weeks During this time they will have 9 study visits during the study
Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata a disease with similar abnormal changes in the body functions like vitiligo in the US EU and Japan China Great Britain and other market applications are pending
Ritlecitinib is studied in patients with non-segmental vitiligo Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin
Non-segmental vitiligo is an autoimmune disorder and is the focus of this study The study will show
if the repigmentation the recovery of pigmentation achieved in study B7981040 also called the parent study will stay the same or will further increase if you keep receiving the same study medicine ritlecitinib 50 milligrams or placebo
Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study
This study is seeking for participants who
have non-segmental vitiligo either active or stable and
received ritlecitinib or placebo for 52 weeks in the parent study A placebo looks exactly like the study capsule but does not contain any medicine in it
All participants in this study will receive the study medicine or placebo The study medicine ritlecitinib 50 milligrams or 100 milligrams or placebo are capsules that are taken by mouth at home every day At week 4 or if it cannot be done then at week 8 study visit you must take the medication at the study site and not at home
Participants may receive the study medicine or placebo for up to 52 weeks
The study will look at the experiences of people receiving the study medicine This will help see if ritlecitinib is better for treating vitiligo
Participants will be involved in this study for a maximum of 60 weeks During this time they will have 9 study visits during the study
Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata a disease with similar abnormal changes in the body functions like vitiligo in the US EU and Japan China Great Britain and other market applications are pending
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 |
|---|---|---|---|
| 2023-505804-42-00 | REGISTRY | CTIS EU | None |