Trial · NCT05650333
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
NCT05650333, Phase 1, Completed, Pfizer; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05650333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05650333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT05650333
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Alopecia Areata
- Interventions
- Ritlecitinib 20 mg
- First posted
- 2022-12-14
- Last updated
- 2024-10-08
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | |
| Secondary | 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 | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Baseline and Day 7 | |
| Secondary | 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. |
| Secondary | Change From Baseline in B Lymphocytes on Day 7 | Baseline and Day 7 | B lymphocytes included CD19 cells. |
| Secondary | Change From Baseline in Natural Killer (NK) Cells on Day 7 | Baseline and Day 7 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 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] | 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. | Nanogram*hours per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | 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. | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | 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 | 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. | Hours | MEDIAN |
| SECONDARY | Apparent Oral Clearance (CL/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | 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. | Liter per hour (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | 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. | Liter | GEOMETRIC_MEAN |
| SECONDARY | Elimination Half-Life (t1/2) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | 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. | Hours | MEAN |
| SECONDARY | Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Baseline and Day 7 | 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. | Picogram per milliliter (pg/mL) | MEDIAN |
| SECONDARY | Change From Baseline in T Lymphocytes on Day 7 | Baseline and Day 7 | 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. | 10^9 cells per liter | MEDIAN |
| SECONDARY | Change From Baseline in B Lymphocytes on Day 7 | Baseline and Day 7 | 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. | 10^6 cells per liter | MEDIAN |
| SECONDARY | Change From Baseline in Natural Killer (NK) Cells on Day 7 | Baseline and Day 7 | 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. | 10^6 cells per liter | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7 | Ritlecitinib 20 mg | 437.5 | Geometric Coefficient of Variation 30 | Nanogram*hours per milliliter (ng*hr/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | Ritlecitinib 20 mg | 208.7 | Geometric Coefficient of Variation 38 | Nanogram per milliliter (ng/mL) | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib | Ritlecitinib 20 mg | 0.500 | Full Range 0.450 | Hours | |
| Apparent Oral Clearance (CL/F) of Ritlecitinib | Ritlecitinib 20 mg | 45.70 | Geometric Coefficient of Variation 30 | Liter per hour (L/hr) | |
| Apparent Volume of Distribution (Vz/F) of Ritlecitinib | Ritlecitinib 20 mg | 74.92 | Geometric Coefficient of Variation 23 | Liter | |
| Elimination Half-Life (t1/2) of Ritlecitinib | Ritlecitinib 20 mg | 1.191 | Standard Deviation 0.10776 | Hours | |
| Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Ritlecitinib 20 mg | Baseline | 121.0 | Full Range 74.7 to 888.0 | Picogram per milliliter (pg/mL) |
| Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Ritlecitinib 20 mg | Change at Day 7 | -9.9 | Full Range -555.0 to 104.0 | Picogram per milliliter (pg/mL) |
| Change From Baseline in T Lymphocytes on Day 7 | Ritlecitinib 20 mg | CD3 cells: Baseline | 1.8 | Full Range 0.8 to 3.4 | 10^9 cells per liter |
| Change From Baseline in T Lymphocytes on Day 7 | Ritlecitinib 20 mg | CD3 cells: Change at Day 7 | -0.0 | Full Range -1.3 to 2.0 | 10^9 cells per liter |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (7 Days) | STARTED | Ritlecitinib 20 mg | 15 | |
| Treatment Period (7 Days) | COMPLETED | Ritlecitinib 20 mg | 14 | |
| Treatment Period (7 Days) | NOT COMPLETED | Ritlecitinib 20 mg | 1 | |
| Follow-up (35 Days After Last Dose) | STARTED | Ritlecitinib 20 mg | 15 | |
| Follow-up (35 Days After Last Dose) | COMPLETED | Ritlecitinib 20 mg | 15 | |
| Follow-up (35 Days After Last Dose) | NOT COMPLETED | Ritlecitinib 20 mg | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Ritlecitinib 20 mg QD | 1 | 15 | 1 |
| other | Vomiting | Gastrointestinal disorders | Ritlecitinib 20 mg QD | 1 | 15 | 1 |
| other | Urticaria | Skin and subcutaneous tissue disorders | Ritlecitinib 20 mg QD | 1 | 15 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Ritlecitinib 20 mg QD | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ritlecitinib 20 mg QD | 0 | 15 |
| Total, other adverse events | Ritlecitinib 20 mg QD | 3 | 15 |
| Total, serious adverse events | Ritlecitinib 20 mg QD | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39924925 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05650333
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