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A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age

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ClinicalTrials.gov Identifier: NCT05650333
Recruitment Status : Recruiting
First Posted : December 14, 2022
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of the study is to evaluate the pharmacokinetics (how the medicine is changed and eliminated from your body after you take it) and pharmacodynamics (effects of the medicine in the body) of the study medicine (called Ritlecitinib) in children of 6 to <12 years of age with Alopecia Areata, a condition of scalp hair loss. 12 children with alopecia areata will be participating in this study. All participants will receive study medicine with a dose of 20 milligram (mg) orally once daily for 7 days. 5 blood samples will be collected on day 7 for pharmacokinetic evaluation and 2 blood samples each at screening and on Day 7 will be collected for pharmacodynamic evaluation. Participants will take part in the study for about 10 weeks.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Ritlecitinib 20 mg Phase 1

Detailed Description:

This is an interventional, Pharmacokinetic (PK), Pharmacodynamic (PD), phase 1, open label study in children 6 to less than 12 years of age with ≥50% scalp hair loss due to severe alopecia areata. The purpose of the study is to collect data to support dose selection for subsequent studies in the same population.

Participants will be screened and, if all eligibility criteria are met, will receive the first dose of Investigational product within 28 days after the screening visit.

Participants will receive 20 mg ritlecitinib in one dose, daily, for 7 consecutive days. Blood samples for pharmacodynamic evaluation will be collected on screening and Day 7. Blood samples for pharmacokinetic evaluation will be collected on Day 7 at: 0 hr (pre-dose), 0.5 hr, 1 hr, 3 hrs, and 8 hrs after dosing.

At least 12 evaluable participants with respect to the primary endpoint will be enrolled in the study.

Participants and their parents/legal guardians will be required to visit the study site 3 times during the study (Screening, Day 1 and Day 7) A safety follow-up visit will be conducted by phone, 28 to 35 days after the last dose of ritlecitinib.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: AN INTERVENTIONAL PK, PD, PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE PK AND PD OF MULTIPLE-DOSE RITLECITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
Actual Study Start Date : March 2, 2023
Estimated Primary Completion Date : February 11, 2024
Estimated Study Completion Date : February 11, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ritlecitinib 20 mg
Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).
 Drug: Ritlecitinib 20 mg
orally administered, Ritlecitinib 20 mg once daily (QD)


Outcome Measures
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Primary Outcome Measures :
  1. Area under the plasma concentration time profile over the dosing interval 24 hrs, at steady-state (AUC24) on Day 7 [ Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 ]
    AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 ]
    Maximum Observed Plasma Concentration

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 ]
    Time to Reach Maximum Observed Plasma Concentration

  3. Apparent Oral Clearance (CL/F) [ Time Frame: Day 7 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

  4. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  5. Terminal elimination Half-Life (t1/2) [ Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 ]
    Terminal elimination half-life.

  6. Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells) [ Time Frame: Day 7 ]
    Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)

  7. Incidence of treatment emergent adverse event (TEAE) [ Time Frame: Baseline through Week 5 (Day 35) ]
    To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.

  8. Incidence of Treatment related AEs [ Time Frame: Baseline through week 5 (Day 35) ]
    To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.

  9. Incidence of Serious AEs (SAEs) [ Time Frame: Baseline through week 5 (Day 35) ]
    To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.

  10. Incidence of AEs leading to discontinuation [ Time Frame: Baseline through Day 7 ]
    To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.

  11. Clinically significant abnormalities in vital signs [ Time Frame: Baseline through Day 7 ]
    To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.

  12. Clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Day 7 ]
    To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.

  13. For overall taste, percent of participants reporting likeability on the scale from 1-5 will be reported [ Time Frame: Day 1 and 7 ]
    Overall taste assesses the degree that a participant likes or dislikes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.

  14. For overall mouthfeel, percent of participants reporting how the medicine felt on the scale from 1-5 will be reported. [ Time Frame: Day 1 and 7 ]
    Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire

  15. For overall volume, percent of participants reporting likeability of the amount of medicine taken on the scale from 1-5 will be reported. [ Time Frame: Day 1 and 7 ]
    Volume assesses the participant experience on the amount of medicine taken. It is scored based on taste assessment questionnaire


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria:

  1. Participants who are 6 to less than12 years old at the baseline visit.
  2. A diagnosis of severe AA, including AT and AU, with ≥50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits, without evidence of terminal hair regrowth within the previous 12 months.

Key Exclusion Criteria:

  1. A known congenital cause of AA, other systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc) or other etiology of hair loss (eg, telogen effluvium, androgenetic alopecia, etc).
  2. Any present malignancies or history of malignancies, history of any lymphoproliferative disorder
  3. History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex.
  4. Other medical or psychiatric condition (including recent [within the past year] or active suicidal ideation/behavior) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  5. Not up to date with all age appropriate vaccines (including 2-dose vaccination for varicella) or vaccination with attenuated live vaccine within 6 weeks of first dose of study medicine.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05650333


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
California Dermatology & Clinical Research Institute Recruiting
Encinitas, California, United States, 92024
United States, Florida
Pediatric Skin Research,LLC Recruiting
Coral Gables, Florida, United States, 33146
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC Not yet recruiting
Indianapolis, Indiana, United States, 46250
United States, Oklahoma
Vital Prospects Clinical Research Institute, PC Not yet recruiting
Tulsa, Oklahoma, United States, 74136
United States, Texas
Texas Dermatology and Laser Specialists Recruiting
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05650333    
Other Study ID Numbers: B7981031
First Posted: December 14, 2022    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical