Alopecia Areata
Conditions
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.
Interventions
DRUGRitlecitinib 20 mg
orally administered, Ritlecitinib 20 mg once daily (QD)
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7 | Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose] | Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | — |
| Apparent Oral Clearance (CL/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. |
| Apparent Volume of Distribution (Vz/F) of Ritlecitinib | 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. Vz/F is influenced by the fraction absorbed. |
| Elimination Half-Life (t1/2) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase. |
| Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Baseline and Day 7 | — |
| Change From Baseline in T Lymphocytes on Day 7 | Baseline and Day 7 | T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes. |
| Change From Baseline in B Lymphocytes on Day 7 | Baseline and Day 7 | B lymphocytes included CD19 cells. |
| Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Treatment Related AEs | Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness was judged by investigator. |
| Number of Participants With Serious AEs (SAEs) | Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With AEs Leading to Treatment Discontinuation | Day 1 up to Day 7 | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Day 1 up to Day 7 | Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator. |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Day 1 up to Day 7 | Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance of any laboratory abnormality was judged by investigator. |
| Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1 and 7 | The pediatric taste questionnaire included 3 questions regarding: 1) Overall Taste (likeability in tase), 2) Overall Mouthfeel (how the medicine felt) and 3) Overall Volume of Medicine (likeability of the amount of medicine). Each question ranged from 1 (most favorable) to 5 (least favorable), higher scores indicates less liking to medicine. Ritlecitinib was provided as capsules; for administration, the capsules were dissolved in water and the contents of the capsule in water were taken according to the dosing administration instructions. |
| Change From Baseline in Natural Killer (NK) Cells on Day 7 | Baseline and Day 7 | — |
Countries
United States
Participant flow
Pre-assignment details
A total of 15 participants, 6 to less than 12 years of age with greater than or equal to (\>=) 50% scalp hair loss due to alopecia areata, were enrolled. Study started from 02 March 2023 and completed on 11 August 2023.
Participants by arm
| Arm | Count |
|---|---|
| Ritlecitinib 20 mg Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment Period (7 Days) | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Ritlecitinib 20 mg |
|---|---|
| Age, Continuous | 8.5 Years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 3 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7
Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7.
Time frame: Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose]
Population: Pharmacokinetic (PK) parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 20 mg | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7 | 437.5 Nanogram*hours per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 30 |
Secondary
Apparent Oral Clearance (CL/F) of Ritlecitinib
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Time frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 20 mg | Apparent Oral Clearance (CL/F) of Ritlecitinib | 45.70 Liter per hour (L/hr) | Geometric Coefficient of Variation 30 |
Secondary
Apparent Volume of Distribution (Vz/F) of Ritlecitinib
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. 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
Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 20 mg | Apparent Volume of Distribution (Vz/F) of Ritlecitinib | 74.92 Liter | Geometric Coefficient of Variation 23 |
Secondary
Change From Baseline in B Lymphocytes on Day 7
B lymphocytes included CD19 cells.
Time frame: Baseline and Day 7
Population: The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ritlecitinib 20 mg | Change From Baseline in B Lymphocytes on Day 7 | Baseline | 439.0 10^6 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in B Lymphocytes on Day 7 | Change at Day 7 | -19.0 10^6 cells per liter |
Secondary
Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7
Time frame: Baseline and Day 7
Population: The pharmacodynamic (PD) parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ritlecitinib 20 mg | Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Baseline | 121.0 Picogram per milliliter (pg/mL) |
| Ritlecitinib 20 mg | Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Change at Day 7 | -9.9 Picogram per milliliter (pg/mL) |
Secondary
Change From Baseline in Natural Killer (NK) Cells on Day 7
Time frame: Baseline and Day 7
Population: The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ritlecitinib 20 mg | Change From Baseline in Natural Killer (NK) Cells on Day 7 | Baseline | 254.0 10^6 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in Natural Killer (NK) Cells on Day 7 | Change at Day 7 | -25.5 10^6 cells per liter |
Secondary
Change From Baseline in T Lymphocytes on Day 7
T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes.
Time frame: Baseline and Day 7
Population: The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ritlecitinib 20 mg | Change From Baseline in T Lymphocytes on Day 7 | CD3 cells: Baseline | 1.8 10^9 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in T Lymphocytes on Day 7 | CD3 cells: Change at Day 7 | -0.0 10^9 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in T Lymphocytes on Day 7 | CD4 T helper lymphocytes: Baseline | 1.0 10^9 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in T Lymphocytes on Day 7 | CD4 T helper lymphocytes: Change at Day 7 | -0.1 10^9 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in T Lymphocytes on Day 7 | CD8 T cytotoxic lymphocytes: Baseline | 0.6 10^9 cells per liter |
| Ritlecitinib 20 mg | Change From Baseline in T Lymphocytes on Day 7 | CD8 T cytotoxic lymphocytes: Change at Day 7 | 0.0 10^9 cells per liter |
Secondary
Elimination Half-Life (t1/2) of Ritlecitinib
Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase.
Time frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 20 mg | Elimination Half-Life (t1/2) of Ritlecitinib | 1.191 Hours | Standard Deviation 0.10776 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib
Time frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 20 mg | Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 208.7 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
Secondary
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
The pediatric taste questionnaire included 3 questions regarding: 1) Overall Taste (likeability in tase), 2) Overall Mouthfeel (how the medicine felt) and 3) Overall Volume of Medicine (likeability of the amount of medicine). Each question ranged from 1 (most favorable) to 5 (least favorable), higher scores indicates less liking to medicine. Ritlecitinib was provided as capsules; for administration, the capsules were dissolved in water and the contents of the capsule in water were taken according to the dosing administration instructions.
Time frame: Day 1 and 7
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Volume Score | 5 | 3 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Mouthfeel Score | 3 | 3 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Mouthfeel Score | 4 | 5 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Mouthfeel Score | 5 | 1 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Volume Score | 1 | 1 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Volume Score | 2 | 6 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Mouthfeel Score | 3 | 3 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Taste Score | 1 | 1 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Taste Score | 2 | 0 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Taste Score | 3 | 3 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Taste Score | 4 | 3 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Taste Score | 5 | 7 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Mouthfeel Score | 1 | 0 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Mouthfeel Score | 2 | 5 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Mouthfeel Score | 4 | 4 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Mouthfeel Score | 5 | 2 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Volume Score | 1 | 2 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Volume Score | 2 | 5 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Volume Score | 3 | 2 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1: Volume Score | 4 | 2 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Taste Score | 1 | 0 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Taste Score | 2 | 1 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Taste Score | 3 | 4 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Taste Score | 4 | 2 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Taste Score | 5 | 7 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Mouthfeel Score | 1 | 0 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Mouthfeel Score | 2 | 5 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Volume Score | 3 | 2 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Volume Score | 4 | 1 Participants |
| Ritlecitinib 20 mg | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 7: Volume Score | 5 | 4 Participants |
Secondary
Number of Participants With AEs Leading to Treatment Discontinuation
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Day 1 up to Day 7
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 20 mg | Number of Participants With AEs Leading to Treatment Discontinuation | 1 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance of any laboratory abnormality was judged by investigator.
Time frame: Day 1 up to Day 7
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 20 mg | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator.
Time frame: Day 1 up to Day 7
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 20 mg | Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 Participants |
Secondary
Number of Participants With Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 20 mg | Number of Participants With Serious AEs (SAEs) | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 20 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
Secondary
Number of Participants With Treatment Related AEs
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness was judged by investigator.
Time frame: Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)
Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 20 mg | Number of Participants With Treatment Related AEs | 1 Participants |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib
Time frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 20 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib | 0.500 Hours | Full Range 0.45 |