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New treatment option for Severe Alopecia Areata
Official title A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
ClinicalTrials.gov ID: NCT07029828
What this study is testing
What is Ritlecitinib higher dose?
Ritlecitinib higher dose is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for severe alopecia areata.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 14
You may be able to join if
- Participants with alopecia areata (AA) (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the studies B7981027 or B7981031.
- For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline...
You likely can't join if
- Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study...
- During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of...
- Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment...
- Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with \>30 Days between last dose in Study B7981027 and...
- During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the...
- Any present malignancies or history of malignancies or lymphoproliferative disorders.
See the full eligibility criteria
- Participants with alopecia areata (AA) (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the studies B7981027 or B7981031.
- For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.
- Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028
- During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent...
- Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in...
- Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with \>30 Days between last dose in Study B7981027 and first visit of Study B7981028
- During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety...
- Any present malignancies or history of malignancies or lymphoproliferative disorders.
- Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or...
The study team makes the final eligibility decision.
Where it's taking place
- Encinitas, California, United States
- Miami, Florida, United States
- Tamarac, Florida, United States
- Indianapolis, Indiana, United States
- Marriottsville, Maryland, United States
- Waterford, Michigan, United States
- Omaha, Nebraska, United States
- Papillion, Nebraska, United States
- Albuquerque, New Mexico, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- El Paso, Texas, United States
- San Antonio, Texas, United States
- Shanghai, Shanghai Municipality, China
- Prague, Czechia
- Bron, France
- Dijon, France
- Lille, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encinitas, California, United States; Miami, Florida, United States; Tamarac, Florida, United States; Indianapolis, Indiana, United States; Marriottsville, Maryland, United States; Waterford, Michigan, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.