Phase 1
N=15
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
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT05650333 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: 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 — 437.5 Nanogram*hours per milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ritlecitinib 20 mg (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
437.5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib |
208.7 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib |
0.500 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Ritlecitinib |
45.70 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Ritlecitinib |
74.92 | — |
| SECONDARY Elimination Half-Life (t1/2) of Ritlecitinib |
1.191 | — |
| SECONDARY Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 |
121.0; -9.9 | — |
| SECONDARY Change From Baseline in T Lymphocytes on Day 7 |
1.8; -0.0; 1.0; -0.1; 0.6; 0.0 | — |
| SECONDARY Change From Baseline in B Lymphocytes on Day 7 |
439.0; -19.0 | — |
| SECONDARY Change From Baseline in Natural Killer (NK) Cells on Day 7 |
254.0; -25.5 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
3 | — |
| SECONDARY Number of Participants With Treatment Related AEs |
1 | — |
| SECONDARY Number of Participants With Serious AEs (SAEs) |
— | — |
| SECONDARY Number of Participants With AEs Leading to Treatment Discontinuation |
1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
— | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values |
— | — |
| SECONDARY Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire |
1; 0; 3; 3; 7; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05650333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.