A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
NCT ID: NCT07029711
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
225 participants
INTERVENTIONAL
2025-07-31
2027-05-18
Brief Summary
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This study is seeking participants who have:
* at least 50% scalp hair loss due to alopecia areata.
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
* history of clinical response failure to alopecia areata treatment (for children in EU/UK only).
All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo.
The study medicine is a capsule that is taken by mouth. It is taken once each day at home.
The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective.
Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.
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Detailed Description
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This study will have 3 treatment arms, including 2 ritlecitinib dosage levels (higher and lower doses) and 1 placebo arm. The participants will be assessed for study eligibility at the screening visit after informed consent/assent is obtained (as applicable).
Participants will receive study medication for a duration of 24 weeks.
At least 225 participants will be enrolled in the study. At least 30% of total study population will be recruited from Europe.
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), Alopecia Areata Patient Priority Outcomes (AAPPO), 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. Pharmacokinetics of ritlecitinib will be evaluated using sparse sampling.
Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.
Participants completing the 24-week treatment period of the study may have the option to enter the long-term extension (LTE) Study B7981028, if the eligibility criteria are met. Participants who complete the 24-week treatment period of the study but who are ineligible for the LTE study will undergo a 4-week off-treatment follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Sponsor staff who are not directly involved with the conduct of this study will prepare analyses and documentation containing unblinded data while the study is ongoing
Study Groups
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Ritlecitinib higher dose
Participants will receive
1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks.
Ritlecitinib higher dose
Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.
Ritlecitinib lower dose
Participants will receive
1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.
Ritlecitinib lower dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Placebo
Participants will receive
1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.
Placebo
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Interventions
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Ritlecitinib higher dose
Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.
Ritlecitinib lower dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Placebo
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)
* Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.
Exclusion Criteria
* Pre-existing hearing loss.
* Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
* Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
* Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.
6 Years
11 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pediatric Skin Research
Miami, Florida, United States
D&H Tamarac Research Center
Tamarac, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Ear, Nose and Throat Consultants, LLC
Omaha, Nebraska, United States
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
Papillion, Nebraska, United States
Northwest Dermatology Institute
Portland, Oregon, United States
3A Research - West Location
El Paso, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
AMR Clinical
Layton, Utah, United States
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-515438-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B7981027
Identifier Type: -
Identifier Source: org_study_id
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