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Phase 3 Randomized,Double-Blind,Placebo-Controlled to Investigate Efficacy andSafety of Ritlecitinib

UCI Specialty Area: Dermatology
Principal Investigator: Natasha Mesinkovska
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ritlecitinib in Pediatric Participants 6 to less than 12 Years of Age With Severe Alopecia Areata
A Study On:
Alopecia
Skin - Dermatologic

Study Description

Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to less than 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

  1. 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 greater than or equal to 50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
  2. 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)
  3. 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.
  1. Other (non-AA) types of alopecia, including any known congenital cause of AA.
  2. Pre-existing hearing loss.
  3. 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.
  4. Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score greater than or equal to 70).
  5. 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).
  6. Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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