Severe Alopecia Areata study: Ritlecitinib higher dose vs Ritlecitinib lower dose
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?
An investigational oral capsule being studied as a potential treatment for severe alopecia areata. It is designed to inhibit JAK3 and TEC family kinases, which may affect immune signaling pathways involved in hair loss.
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 study aims to learn if the medicine ritlecitinib is safe to use over a long period and how it affects the body.
- Who it's for
- This study is for children who have severe hair loss and have already finished a previous Pfizer study for this condition.
- What's involved
- Participants take one capsule by mouth every day at home. They will also have regular check-ups and blood tests at the clinic.
- Time commitment
- The study lasts up to 3 years and includes 17 visits to the clinic plus monthly phone calls.
- 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 is enrolling
- Irvine, California, United States
- Santa Ana, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- Waterford, Michigan, United States
- Omaha, Nebraska, United States
- Albuquerque, New Mexico, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- Corpus Christi, Texas, United States
- El Paso, Texas, United States
- Pflugerville, Texas, United States
- San Antonio, Texas, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
+ 24 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, but 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?
This study is enrolling now at Irvine, California, United States; Santa Ana, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Skokie, Illinois, United States and 38 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.