- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05650333
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
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Encinitas, California, United States, 92024
- California Dermatology & Clinical Research Institute
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Florida
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Coral Gables, Florida, United States, 33146
- Pediatric Skin Research,LLC
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Miami, Florida, United States, 33155
- Nicklaus Children's Hospital
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Indiana
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Indianapolis, Indiana, United States, 46250
- Dawes Fretzin Clinical Research Group, LLC
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Health Sciences Center
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Albuquerque, New Mexico, United States, 87106
- UNMH
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Vital Prospects Clinical Research Institute, PC
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Oregon
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Portland, Oregon, United States, 97210
- Northwest Dermatology Institute
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Texas
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San Antonio, Texas, United States, 78218
- Texas Dermatology and Laser Specialists
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion criteria:
- Participants who are 6 to less than12 years old at the baseline visit.
- 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:
- 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).
- Any present malignancies or history of malignancies, history of any lymphoproliferative disorder
- History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex.
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ritlecitinib 20 mg
Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).
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orally administered, Ritlecitinib 20 mg once daily (QD)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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AUC is a measure of the plasma concentration of the drug over time.
It is used to characterize drug absorption.
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0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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Maximum Observed Plasma Concentration
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0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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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
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Time to Reach Maximum Observed Plasma Concentration
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0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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Apparent Oral Clearance (CL/F)
Time Frame: Day 7
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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.
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Day 7
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Apparent Volume of Distribution (Vz/F)
Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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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.
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0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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Terminal elimination Half-Life (t1/2)
Time Frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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Terminal elimination half-life.
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0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
Time Frame: Day 7
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Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
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Day 7
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Incidence of treatment emergent adverse event (TEAE)
Time Frame: Baseline through Week 5 (Day 35)
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To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
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Baseline through Week 5 (Day 35)
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Incidence of Treatment related AEs
Time Frame: Baseline through week 5 (Day 35)
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To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
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Baseline through week 5 (Day 35)
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Incidence of Serious AEs (SAEs)
Time Frame: Baseline through week 5 (Day 35)
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To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
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Baseline through week 5 (Day 35)
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Incidence of AEs leading to discontinuation
Time Frame: Baseline through Day 7
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To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
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Baseline through Day 7
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Clinically significant abnormalities in vital signs
Time Frame: Baseline through Day 7
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To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
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Baseline through Day 7
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Clinically significant abnormalities in clinical laboratory values
Time Frame: Baseline through Day 7
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To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
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Baseline through Day 7
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For overall taste, percent of participants reporting likeability on the scale from 1-5 will be reported
Time Frame: Day 1 and 7
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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.
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Day 1 and 7
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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
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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
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Day 1 and 7
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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
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Volume assesses the participant experience on the amount of medicine taken.
It is scored based on taste assessment questionnaire
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Day 1 and 7
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7981031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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