A Phase 1 interventional study of Ritlecitinib 20 mg in Alopecia Areata, sponsored by Pfizer. Completed at 9 sites in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Pfizer · Phase 1, Interventional, and Other
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.
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.
469 studies on the registry are indexed under Alopecia Areata; 91 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 381 interventional studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion criteria:
Key Exclusion Criteria:
Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).
Drug: Ritlecitinib 20 mg
orally administered, Ritlecitinib 20 mg once daily (QD)
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]
Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib
Time frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
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
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
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
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
Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7
Time frame: Baseline and Day 7
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
Change From Baseline in B Lymphocytes on Day 7
B lymphocytes included CD19 cells.
Time frame: Baseline and Day 7
Change From Baseline in Natural Killer (NK) Cells on Day 7
Time frame: Baseline and Day 7
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)
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)
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)
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
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
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
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
| Milestone | Ritlecitinib 20 mg |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | Ritlecitinib 20 mg |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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.
| Nanogram*hours per milliliter (ng*hr/mL) | 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 ± 30 |
| Nanogram per milliliter (ng/mL) | Ritlecitinib 20 mg |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 208.7 ± 38 |
| Hours | Ritlecitinib 20 mg |
|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib | 0.500 ± 0.450 |
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.
| Liter per hour (L/hr) | Ritlecitinib 20 mg |
|---|---|
| Apparent Oral Clearance (CL/F) of Ritlecitinib | 45.70 ± 30 |
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.
| Liter | Ritlecitinib 20 mg |
|---|---|
| Apparent Volume of Distribution (Vz/F) of Ritlecitinib | 74.92 ± 23 |
Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase.
| Hours | Ritlecitinib 20 mg |
|---|---|
| Elimination Half-Life (t1/2) of Ritlecitinib | 1.191 ± 0.10776 |
| Picogram per milliliter (pg/mL) | Ritlecitinib 20 mg |
|---|---|
| Baseline | 121.0 (74.7 to 888.0) |
| Change at Day 7 | -9.9 (-555.0 to 104.0) |
T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes.
| 10^9 cells per liter | Ritlecitinib 20 mg |
|---|---|
| CD3 cells: Baseline | 1.8 (0.8 to 3.4) |
| CD3 cells: Change at Day 7 | -0.0 (-1.3 to 2.0) |
| CD4 T helper lymphocytes: Baseline | 1.0 (0.6 to 1.6) |
| CD4 T helper lymphocytes: Change at Day 7 | -0.1 (-0.6 to 1.1) |
| CD8 T cytotoxic lymphocytes: Baseline | 0.6 (0.2 to 1.5) |
| CD8 T cytotoxic lymphocytes: Change at Day 7 | 0.0 (-0.6 to 0.8) |
B lymphocytes included CD19 cells.
| 10^6 cells per liter | Ritlecitinib 20 mg |
|---|---|
| Baseline | 439.0 (191.0 to 881.0) |
| Change at Day 7 | -19.0 (-116.0 to 766.0) |
| 10^6 cells per liter | Ritlecitinib 20 mg |
|---|---|
| Baseline | 254.0 (85.0 to 729.0) |
| Change at Day 7 | -25.5 (-318.0 to 627.0) |
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.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 3 |
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.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Number of Participants With Treatment Related AEs | 1 |
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.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Number of Participants With Serious AEs (SAEs) | 0 |
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.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Number of Participants With AEs Leading to Treatment Discontinuation | 1 |
Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 |
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.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | 0 |
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.
| Participants | Ritlecitinib 20 mg |
|---|---|
| Day 1: Taste Score — 1 | 1 |
| Day 1: Taste Score — 2 | 0 |
| Day 1: Taste Score — 3 | 3 |
| Day 1: Taste Score — 4 | 3 |
| Day 1: Taste Score — 5 | 7 |
| Day 1: Mouthfeel Score — 1 | 0 |
| Day 1: Mouthfeel Score — 2 | 5 |
| Day 1: Mouthfeel Score — 3 | 3 |
| Day 1: Mouthfeel Score — 4 | 4 |
| Day 1: Mouthfeel Score — 5 | 2 |
| Day 1: Volume Score — 1 | 2 |
| Day 1: Volume Score — 2 | 5 |
| Day 1: Volume Score — 3 | 2 |
| Day 1: Volume Score — 4 | 2 |
| Day 1: Volume Score — 5 | 3 |
| Day 7: Taste Score — 1 | 0 |
| Day 7: Taste Score — 2 | 1 |
| Day 7: Taste Score — 3 | 4 |
| Day 7: Taste Score — 4 | 2 |
| Day 7: Taste Score — 5 | 7 |
| Day 7: Mouthfeel Score — 1 | 0 |
| Day 7: Mouthfeel Score — 2 | 5 |
| Day 7: Mouthfeel Score — 3 | 3 |
| Day 7: Mouthfeel Score — 4 | 5 |
| Day 7: Mouthfeel Score — 5 | 1 |
| Day 7: Volume Score — 1 | 1 |
| Day 7: Volume Score — 2 | 6 |
| Day 7: Volume Score — 3 | 2 |
| Day 7: Volume Score — 4 | 1 |
| Day 7: Volume Score — 5 | 4 |
Collected over Day 1 up to 35 days after last dose (maximum up to Day 42). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ritlecitinib 20 mg QD | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Event | Ritlecitinib 20 mg QD |
|---|---|
| NauseaGastrointestinal disorders | 1/15 |
| VomitingGastrointestinal disorders | 1/15 |
| UrticariaSkin and subcutaneous tissue disorders | 1/15 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/15 |
All participants who were enrolled in the study and were assigned to study intervention.
| Age, Continuous(Years) | Ritlecitinib 20 mg |
|---|---|
| Mean | 8.5 ± 1.60 |
| Sex: Female, Male(Participants) | Ritlecitinib 20 mg |
|---|---|
| Female | 12 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Ritlecitinib 20 mg |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Ritlecitinib 20 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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 of the drug tested here: PF-06651600