Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 7:28 PM
Study NCT ID:
NCT07029828
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031
Status:
RECRUITING
Status Verified Date:
2025-09
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:
B7981028
Brief Summary:
The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.
This study is seeking participants who have:
* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).
* at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.
Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.
This study is seeking participants who have:
* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).
* at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.
Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.
Detailed Description:
Study B7981028 is a Phase 3 long-term, double-blind extension study to evaluate the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA) who have completed previous ritlecitinib studies B7981031 or B7981027 and are eligible to enroll for B7981028 study.
The primary objective of this study is to evaluate the long-term safety and tolerability of ritlecitinib in pediatric participants with severe AA who have completed the studies B7981027 or B7981031. The secondary objectives of this study are to evaluate the long-term efficacy of ritlecitinib, durability of response and effect of ritlecitinib on patient centered outcomes.
All participants in this study will receive ritlecitinib higher or lower dose for up to an additional 3 years following completion of either of the prior parent studies. Participants who received higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in Study B7981028. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will be randomized at a 1:1 ratio to receive higher or lower dose of ritlecitinib in Study B7981028.
At least 140 participants evaluable for primary analysis will be enrolled in Study B7981028.
Participants will be evaluated for treatment continuation criteria at Months 3 and 6 (for those who were previously assigned to active treatment in parent Study B7981027) and at Months 9 and 12 in Study B7981028 (for those who previously completed Study B7981031 or were assigned to placebo in the parent Study B7981027). Ritlecitinib treatment will be discontinued for any participant who does not meet the study treatment continuation criteria.
Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.
The efficacy assessments include Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments. Patient reported outcomes including Patient's Global Impression of Change (PGI-C), Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Anxiety Short Form 8a and Depressive Symptoms Short Form 6a, Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), and modified Children's Dermatology Life Quality Index (CDLQI) will be assessed throughout the study.
The primary objective of this study is to evaluate the long-term safety and tolerability of ritlecitinib in pediatric participants with severe AA who have completed the studies B7981027 or B7981031. The secondary objectives of this study are to evaluate the long-term efficacy of ritlecitinib, durability of response and effect of ritlecitinib on patient centered outcomes.
All participants in this study will receive ritlecitinib higher or lower dose for up to an additional 3 years following completion of either of the prior parent studies. Participants who received higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in Study B7981028. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will be randomized at a 1:1 ratio to receive higher or lower dose of ritlecitinib in Study B7981028.
At least 140 participants evaluable for primary analysis will be enrolled in Study B7981028.
Participants will be evaluated for treatment continuation criteria at Months 3 and 6 (for those who were previously assigned to active treatment in parent Study B7981027) and at Months 9 and 12 in Study B7981028 (for those who previously completed Study B7981031 or were assigned to placebo in the parent Study B7981027). Ritlecitinib treatment will be discontinued for any participant who does not meet the study treatment continuation criteria.
Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.
The efficacy assessments include Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments. Patient reported outcomes including Patient's Global Impression of Change (PGI-C), Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Anxiety Short Form 8a and Depressive Symptoms Short Form 6a, Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), and modified Children's Dermatology Life Quality Index (CDLQI) will be assessed throughout the study.
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-515439-31-00 | REGISTRY | CTIS (EU) | View |