Back to resultsA 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
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ritlecitinib 20 mg
Sponsored by
About this trial
This is an interventional other trial for Alopecia Areata
Eligibility Criteria
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.
Sites / Locations
- California Dermatology & Clinical Research Institute
- Pediatric Skin Research,LLC
- Nicklaus Children's Hospital
- Dawes Fretzin Clinical Research Group, LLC
- University of New Mexico Health Sciences Center
- UNMH
- Vital Prospects Clinical Research Institute, PC
- Northwest Dermatology Institute
- Texas Dermatology and Laser Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ritlecitinib 20 mg
Arm Description
Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).
Outcomes
Primary Outcome Measures
Area under the plasma concentration time profile over the dosing interval 24 hrs, at steady-state (AUC24) 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
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to Reach Maximum Observed Plasma Concentration
Apparent Oral Clearance (CL/F)
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.
Apparent Volume of Distribution (Vz/F)
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.
Terminal elimination Half-Life (t1/2)
Terminal elimination half-life.
Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
Incidence of treatment emergent adverse event (TEAE)
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Incidence of Treatment related AEs
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Incidence of Serious AEs (SAEs)
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Incidence of AEs leading to discontinuation
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Clinically significant abnormalities in vital signs
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Clinically significant abnormalities in clinical laboratory values
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
For overall taste, percent of participants reporting likeability on the scale from 1-5 will be reported
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.
For overall mouthfeel, percent of participants reporting how the medicine felt on the scale from 1-5 will be reported.
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
For overall volume, percent of participants reporting likeability of the amount of medicine taken on the scale from 1-5 will be reported.
Volume assesses the participant experience on the amount of medicine taken. It is scored based on taste assessment questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05650333
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ritlecitinib 20 mg
Arm Type
Experimental
Arm Description
Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).
Intervention Type
Drug
Intervention Name(s)
Ritlecitinib 20 mg
Intervention Description
orally administered, Ritlecitinib 20 mg once daily (QD)
Primary Outcome Measure Information:
Title
Area under the plasma concentration time profile over the dosing interval 24 hrs, at steady-state (AUC24) on Day 7
Description
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Time Frame
0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Maximum Observed Plasma Concentration
Time Frame
0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
Time to Reach Maximum Observed Plasma Concentration
Time Frame
0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Title
Apparent Oral Clearance (CL/F)
Description
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.
Time Frame
Day 7
Title
Apparent Volume of Distribution (Vz/F)
Description
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.
Time Frame
0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Title
Terminal elimination Half-Life (t1/2)
Description
Terminal elimination half-life.
Time Frame
0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Title
Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
Description
Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
Time Frame
Day 7
Title
Incidence of treatment emergent adverse event (TEAE)
Description
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Time Frame
Baseline through Week 5 (Day 35)
Title
Incidence of Treatment related AEs
Description
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Time Frame
Baseline through week 5 (Day 35)
Title
Incidence of Serious AEs (SAEs)
Description
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Time Frame
Baseline through week 5 (Day 35)
Title
Incidence of AEs leading to discontinuation
Description
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Time Frame
Baseline through Day 7
Title
Clinically significant abnormalities in vital signs
Description
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Time Frame
Baseline through Day 7
Title
Clinically significant abnormalities in clinical laboratory values
Description
To evaluate the safety and tolerability of ritlecitinib in children with alopecia areata 6 to less than 12 years of age.
Time Frame
Baseline through Day 7
Title
For overall taste, percent of participants reporting likeability on the scale from 1-5 will be reported
Description
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.
Time Frame
Day 1 and 7
Title
For overall mouthfeel, percent of participants reporting how the medicine felt on the scale from 1-5 will be reported.
Description
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
Time Frame
Day 1 and 7
Title
For overall volume, percent of participants reporting likeability of the amount of medicine taken on the scale from 1-5 will be reported.
Description
Volume assesses the participant experience on the amount of medicine taken. It is scored based on taste assessment questionnaire
Time Frame
Day 1 and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Pediatric Skin Research,LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
UNMH
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Northwest Dermatology Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7981031
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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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