Alopecia AreataPhase 1NCT05650333
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
A Phase 1 study testing Ritlecitinib 20 mg in people with Alopecia Areata, run by Pfizer at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Ritlecitinib 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Mar 2023to 11 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102
UNMH
Albuquerque, New Mexico, 87106
Pediatric Skin Research,LLC
Coral Gables, Florida, 33146
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Nicklaus Children's Hospital
Miami, Florida, 33155
Northwest Dermatology Institute
Portland, Oregon, 97210
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
About this study
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
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.
Read the 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.
- Conditions
- Alopecia Areata
- Being tested
- Ritlecitinib 20 mg
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritlecitinib 20 mgDrug
orally administered, Ritlecitinib 20 mg once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Ritlecitinib 20 mg | Experimental | Participants will receive Ritlecitinib 20 mg by mouth once daily (QD). Receives: Drug: Ritlecitinib 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Secondary outcomes (16)
Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and Day 7
Change From Baseline in B Lymphocytes on Day 7
B lymphocytes included CD19 cells.
Measured: Baseline and Day 7
Change From Baseline in Natural Killer (NK) Cells on Day 7
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start2 Mar 2023
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650333
- Sponsor's protocol ID
- B7981031
- Status last verified
- Jun 2024
- First submitted
- 6 Dec 2022
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Gonzalez ME, Browning J, Smith S, Plotka A, Zhu JD, Parvatini S, Huh Y, Wolk R. A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata. Pediatr Dermatol. 2025 Jul-Aug;42(4):742-746. doi: 10.1111/pde.15895. Epub 2025 Feb 9.
PubMed 39924925
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05650333
- Acronym / sponsor ID
- B7981031
- Conditions
- Alopecia Areata
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ritlecitinib 20 mg | Experimental | Drug: Ritlecitinib 20 mgParticipants will receive Ritlecitinib 20 mg by mouth once daily (QD). |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritlecitinib 20 mgorally administered, Ritlecitinib 20 mg once daily (QD) | Drug | Ritlecitinib 20 mg |
Primary outcome
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib 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]
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.
16 secondary outcomes
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
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
Time frame: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
Elimination Half-Life (t1/2) of Ritlecitinib
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
Time frame: Baseline and Day 7
Change From Baseline in B Lymphocytes on Day 7
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)
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
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)
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
Time frame: Day 1 up to Day 7
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Day 1 up to Day 7
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Time frame: Day 1 up to Day 7
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Time frame: Day 1 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39924925Gonzalez ME, Browning J, Smith S, Plotka A, Zhu JD, Parvatini S, Huh Y, Wolk R. A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata. Pediatr Dermatol. 2025 Jul-Aug;42(4):742-746. doi: 10.1111/pde.15895. Epub 2025 Feb 9.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ritlecitinib 20 mg in people with Alopecia Areata, run by Pfizer at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05650333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.