A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

Phase 3RecruitingNCT07029711

Pfizer225 enrolled

Overview

The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss. 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.

Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to \<12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritlecitinib and to evaluate the effect of ritlecitinib on patient centered outcomes. 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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months. * 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: * Other (non-AA) types of alopecia, including any known congenital cause of AA. * 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.

Locations (17)

Pediatric Skin Research

Miami, Florida, United States

RECRUITING

D&H Tamarac Research Center

Tamarac, Florida, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

RECRUITING

Ear, Nose and Throat Consultants, LLC

Omaha, Nebraska, United States

RECRUITING

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, United States

RECRUITING

Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)

Papillion, Nebraska, United States

RECRUITING

Northwest Dermatology Institute

Portland, Oregon, United States

RECRUITING

3A Research - West Location

El Paso, Texas, United States

RECRUITING

Austin Institute for Clinical Research

Pflugerville, Texas, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

RECRUITING

...and 7 more locations

Outcomes

Primary Outcomes

For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20.

The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 24

For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10.

The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 24

Secondary Outcomes

For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved".

The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 24

For all countries: Change from baseline (CFB) in SALT score.

The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: Response based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint).

The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18

For all countries: Response based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint).

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18.

For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint).

The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18.

For all countries: Response based on improvement from baseline for each Alopecia Areata Patient Priority Outcomes (AAPPO) item.

The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: CFB in PROMIS Parent Proxy Anxiety Symptoms T-score.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)).

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score in participants with an abnormal EBA at baseline.

The difference in proportions of participants with the EBA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score in participants with an abnormal ELA at baseline.

The difference in proportions of participants with the ELA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: Plasma concentration of ritlecitinib.

Time frame: Post dose hour 1 and hour 3 at day 28 or day 56.

For all countries: Incidence of treatment emergent Adverse Events (AEs).

To evaluate safety and tolerability of ritlecitinib over time.

Time frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months).

For all countries: Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.

To evaluate safety and tolerability of ritlecitinib over time.

CFB in AAPPO activity limitation score.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

For all countries: Acceptability and palatability assessment.

To evaluate acceptability and palatability of the age-appropriate formulation.

Time frame: Week 2 and Week 18

CFB in AAPPO emotional symptoms score.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.

A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

Overview

Conditions

Interventions

Eligibility

Locations (17)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts