Alopecia Areata
Conditions
Keywords
alopecia totalis, alopecia universalis, hair loss, alopecia, JAK, ritlecitinib, PF-06651600, double-blind, placebo-controlled, phase 2a
Brief summary
This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp hair loss due to Alopecia Areata (AA).
Interventions
DRUGPF-06651600
50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD
DRUGPlacebo
tablet, dosed as 4 tablets QD or 1 tablet QD
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis. * At least 25% hair loss due to alopecia areata * Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs) * Must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy * Signed informed consent * Stable regimen for other medications before and during the study
Exclusion criteria
* Other significant medical conditions * Occupational or recreational noise exposure * History of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy * HbA1c \> or = 7.5% at Screening * Recurrent or disseminated Herpes Zoster * Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months * Active or latent (insufficiently treated) Hepatitis * Active or latent (insufficiently treated) TB * Concomitant medications associated with peripheral neurologic or hearing loss * Protocol specific laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9 | Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | BAEP interwave I-V latency (in milliseconds) was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9 | Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | BAEP interwave I-V latency was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E | Baseline, Months 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase. | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6 | Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E | Baseline, Month 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase. | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9 | Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. | The endpoint axonal dystrophy referred to the percentage of IENF with axonal swellings. Axonal swellings were evaluated in peripheral skin punch biopsies from the distal part of lower extremities. Axonal swellings were counted by axon. Any IENF with single or multiple swellings was counted as a single event, ie, a single axon with axonal swellings. For each participant, data were reported as the percentage of IENF with any number of swellings. IENF was assessed at Day 1 and Month 9. Participants who had entered the Active Therapy Extension Phase at Month 6 had a skin punch biopsy taken at Month 6 for IENF assessments instead of at Month 9. The skin biopsy was collected before the start of Active Therapy Extension Phase. |
| Change From Baseline in Percentage of IENFs With Axonal Swelling in Skin Punch Biopsies at Month 15E | Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. | The endpoint axonal dystrophy referred to the percentage of IENF with axonal swellings. Axonal swellings were evaluated in peripheral skin punch biopsies from the distal part of lower extremities. Axonal swellings were counted by axon. Any IENF with single or multiple swellings was counted as a single event, ie, a single axon with axonal swellings. For each participant, data were reported as the percentage of IENF with any number of swellings. |
| Change From Baseline in Intraepidermal Nerve Fiber Density (IENFD) in Skin Punch Biopsies at Month 9 | Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. | IENFD was evaluated in peripheral skin punch biopsies from the distal part of lower extremities. IENFD was measured by counting the number of fibers and fiber branches that independently crossed the dermal-epidermal barrier (basement membrane). Secondary branching was excluded from quantification and fragments were not counted. The length of the histology section was measured (mm) and the linear epidermal nerve fiber density was reported as number of intraepidermal nerve fibers/mm. |
| Change From Baseline in IENFD in Skin Punch Biopsies at Month 15E | Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. | IENFD was evaluated in peripheral skin punch biopsies from the distal part of lower extremities. IENFD was measured by counting the number of fibers and fiber branches that independently crossed the dermal-epidermal barrier (basement membrane). Secondary branching was excluded from quantification and fragments were not counted. The length of the histology section was measured (mm) and the linear epidermal nerve fiber density was reported as number of intraepidermal nerve fibers/mm. |
| Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 | Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E | Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 | Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E | Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase) | Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized using number of participants by treatment group at each intensity level. All participants had Wave V on BAEP present at stimulus intensities ranging from 80 dB to 40 dB up to Month 15E except for 1 participant. At Month 9 (TP1), 1 participant in 200/50/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. Fluctuations were seen in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6 on the right side. |
| Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase) | Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. |
| Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase) | Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. All participants had Wave V on BAEP present at stimulus intensities ranging from 80 dB to 40 dB up to Month 15E except for 1 participant. At Month 9 (TP1), 1 participant in 200/50/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. Fluctuations were seen in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6 on the right side. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Approximately 16 months | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. |
| Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Approximately 16 months | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator. |
| Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6 | Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation. |
| Number of Participants With Temporary Drug Discontinuation Due to AEs | Approximately 16 months | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Approximately 16 months | Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator. |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Approximately 16 months | Safety laboratory assessments included the categories of Hematology, Chemistry, Urinalysis and other tests. The clinical significance was determined by the investigator. |
| Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Baseline, Month 3E, 6E, 9E, 12E and 15E (Month 3, 6, 9, 12 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase. | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score in Placebo-Controlled Phase = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Baseline, Month 3E, 6E, 9E, 12E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase) | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Months 1, 3, 6 and 9 | The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, Since the start of the study, my alopecia areata has: …. The participants selected one of seven responses ranging from greatly improved to greatly worsened. This Outcome Measure presented the number of participants with PGI-C response which was defined as greatly improved or moderately improved. Participants with missing PGI-C scores were considered as non-responders. |
| Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 3E, 6E, 9E, 12E and 15E | The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, Since the start of the study, my alopecia areata has: …. The participants selected one of seven responses ranging from greatly improved to greatly worsened. This Outcome Measure presented the number of participants with PGI-C response which was defined as greatly improved or moderately improved. Participants with missing PGI-C scores were considered as non-responders. |
| Number of Participants With TEAEs and TESAEs: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of SAE. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. |
| Number of Participants Who Discontinued From Study Due to AEs: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator. |
| Number of Participants Who Discontinued Study Drug Due to AE and Continued Study: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This outcome measure presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator. |
| Number of Participants With Temporary Drug Discontinuation Due to AEs: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs: Extension Phase (TP3) | From screening up to 28 days follow up after last dose of study treatment (maximum up to 19 months) | Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants were refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator. |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values: Extension Phase (TP3) | From screening up to 28 days after last dose of study treatment (maximum up to 19 months) | Safety laboratory assessments included the categories of hematology, chemistry, urinalysis and other tests. The clinical significance was determined by the investigator. |
| Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Approximately 16 months | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This Outcome Measures presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator. |
| Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase) | Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. At Month 9, 1 participant in 200/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. The event was unilateral and showed fluctuations in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6. |
Countries
Australia, Canada, Poland, United States
Participant flow
Pre-assignment details
A total of 131 participants were screened for this study; 71 participants were enrolled and randomized to double-blind treatment and treated. All enrolled participants received tablets until Month 24 and then all but 2 switched to capsules at the start of Extension Phase.
Participants by arm
| Arm | Count |
|---|---|
| Ritlecitinib 200/50/50 mg QD In the 9-Month Placebo-Controlled Phase, each participant received ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and received 1 tablet of ritlecitinib 50 mg QD during the remainder of this treatment phase. In the 15-Month Active Therapy Extension Phase, each participant received 1 tablet of ritlecitinib 50 mg QD and 3 tablets of placebo QD during the initial 4-week period, and then received 1 tablet of ritlecitinib 50 mg QD during the remainder of this phase. | 36 |
| Placebo -> Ritlecitinib 200/50 mg QD In the 9-month Placebo-Controlled Phase, each participant received a total of 4 tablets of Placebo QD during the initial 4-week period, and received 1 tablet of Placebo QD during the remainder of this treatment phase. In the 15-month Active Therapy Extension Phase, each participant received Ritlecitinib 200 mg QD (50 mg/tablet ×4) during the initial 4-week period, and then received 1 tablet of Ritlecitinib 50 mg QD during the remainder of this treatment phase. | 35 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Active Therapy Extension Phase | Adverse Event | 1 | 0 | 0 |
| Active Therapy Extension Phase | Lack of Efficacy | 1 | 0 | 0 |
| Active Therapy Extension Phase | Lost to Follow-up | 0 | 1 | 0 |
| Active Therapy Extension Phase | Physician Decision | 1 | 0 | 0 |
| Active Therapy Extension Phase | Withdrawal by Subject | 8 | 8 | 0 |
| Extension Phase | Adverse Event | 0 | 0 | 1 |
| Extension Phase | Approved Drug Available for Indication | 0 | 0 | 7 |
| Extension Phase | Lack of Efficacy | 0 | 0 | 2 |
| Extension Phase | Study Terminated By Sponsor | 0 | 0 | 32 |
| Extension Phase | Withdrawal by Subject | 0 | 0 | 3 |
| Placebo-Controlled Phase | Adverse Event | 1 | 0 | 0 |
| Placebo-Controlled Phase | Lost to Follow-up | 1 | 1 | 0 |
| Placebo-Controlled Phase | Protocol Violation | 1 | 0 | 0 |
| Placebo-Controlled Phase | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo -> Ritlecitinib 200/50 mg QD | Total | Ritlecitinib 200/50/50 mg QD |
|---|---|---|---|
| Age, Continuous | 34.2 Years STANDARD_DEVIATION 8.95 | 34.7 Years STANDARD_DEVIATION 9.25 | 35.1 Years STANDARD_DEVIATION 9.64 |
| Baseline Intraepidermal Nerve Fiber Density (IENFD) | 11.0 fibers/mm STANDARD_DEVIATION 3.95 | 10.6 fibers/mm STANDARD_DEVIATION 3.87 | 10.2 fibers/mm STANDARD_DEVIATION 3.81 |
| Baseline Percentage of Nerve Fibers With Axonal Swelling | 1.8 Percentage of Nerve Fibers STANDARD_DEVIATION 2.07 | 1.8 Percentage of Nerve Fibers STANDARD_DEVIATION 2.27 | 1.8 Percentage of Nerve Fibers STANDARD_DEVIATION 2.48 |
| Baseline Severity of Alopecia Tool (SALT) Scores for Non-AT/AU Participants | 53.7 Units on a scale STANDARD_DEVIATION 24.18 | 56.9 Units on a scale STANDARD_DEVIATION 27.55 | 59.6 Units on a scale STANDARD_DEVIATION 30.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 54 Participants | 26 Participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 35 | 0 / 32 | 0 / 33 | 0 / 45 |
| other Total, other adverse events | 23 / 36 | 17 / 35 | 16 / 32 | 12 / 33 | 10 / 45 |
| serious Total, serious adverse events | 0 / 36 | 1 / 35 | 2 / 32 | 1 / 33 | 1 / 45 |
Outcome results
Primary
Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9
BAEP interwave I-V latency was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9 | 0.031 ms |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9 | 0.022 ms |
95% CI: [-0.052, 0.07]Mixed Models Analysis
Primary
Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9
BAEP interwave I-V latency (in milliseconds) was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9 | 0.011 Millisecond (ms) |
| Placebo | Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9 | -0.010 Millisecond (ms) |
95% CI: [-0.056, 0.097]Mixed Models Analysis
Secondary
Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E
SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.
Time frame: Baseline, Month 3E, 6E, 9E, 12E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Baseline | 67.0 Units on a scale | Standard Deviation 33.52 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 3E | -41.7 Units on a scale | Standard Deviation 33.97 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 6E | -38.0 Units on a scale | Standard Deviation 29.87 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 9E | -38.7 Units on a scale | Standard Deviation 29.9 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 12E | -41.6 Units on a scale | Standard Deviation 29.7 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 15E | -44.8 Units on a scale | Standard Deviation 28.37 |
| Placebo | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 12E | -49.7 Units on a scale | Standard Deviation 33.92 |
| Placebo | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Baseline | 69.5 Units on a scale | Standard Deviation 29.67 |
| Placebo | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 3E | -39.4 Units on a scale | Standard Deviation 32.89 |
| Placebo | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 9E | -47.4 Units on a scale | Standard Deviation 33.36 |
| Placebo | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 15E | -50.8 Units on a scale | Standard Deviation 33.49 |
| Placebo | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Change at Month 6E | -44.2 Units on a scale | Standard Deviation 33.37 |
Secondary
Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9
SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score in Placebo-Controlled Phase = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.
Time frame: Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Month 3 | -23.0 Units on a scale |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Month 6 | -35.2 Units on a scale |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Month 9 | -38.2 Units on a scale |
| Placebo | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Month 3 | -2.7 Units on a scale |
| Placebo | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Month 6 | -5.1 Units on a scale |
| Placebo | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Month 9 | -6.8 Units on a scale |
Secondary
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 | Month 6 | -0.047 μV |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 | Month 9 | -0.045 μV |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 | Month 6 | -0.019 μV |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9 | Month 9 | -0.049 μV |
Comparison: Month 695% CI: [-0.076, 0.02]Mixed Models Analysis
Comparison: Month 995% CI: [-0.049, 0.056]Mixed Models Analysis
Secondary
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E | Month 15E | -0.047 μV | Standard Deviation 0.1314 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E | Month 9E | -0.058 μV | Standard Deviation 0.1209 |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E | Month 9E | -0.025 μV | Standard Deviation 0.1307 |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E | Month 15E | -0.023 μV | Standard Deviation 0.1217 |
Secondary
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 | Month 6 | -0.031 Microvolts (μV) |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 | Month 9 | -0.051 Microvolts (μV) |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 | Month 6 | -0.017 Microvolts (μV) |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9 | Month 9 | 0.008 Microvolts (μV) |
Comparison: Month 695% CI: [-0.059, 0.03]Mixed Models Analysis
Comparison: Month 995% CI: [-0.107, -0.012]Mixed Models Analysis
Secondary
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that amplitude data were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E | Month 9E (Month 9 in the Active Therapy Extension Phase) | -0.052 μV | Standard Deviation 0.1109 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E | Month 15E (Month 15 in the Active Therapy Extension Phase) | -0.065 μV | Standard Deviation 0.1513 |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E | Month 9E (Month 9 in the Active Therapy Extension Phase) | -0.025 μV | Standard Deviation 0.1649 |
| Placebo | Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E | Month 15E (Month 15 in the Active Therapy Extension Phase) | -0.042 μV | Standard Deviation 0.1214 |
Secondary
Change From Baseline in IENFD in Skin Punch Biopsies at Month 15E
IENFD was evaluated in peripheral skin punch biopsies from the distal part of lower extremities. IENFD was measured by counting the number of fibers and fiber branches that independently crossed the dermal-epidermal barrier (basement membrane). Secondary branching was excluded from quantification and fragments were not counted. The length of the histology section was measured (mm) and the linear epidermal nerve fiber density was reported as number of intraepidermal nerve fibers/mm.
Time frame: Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in IENFD in Skin Punch Biopsies at Month 15E | 0.2 fibers/mm | Standard Deviation 2.85 |
| Placebo | Change From Baseline in IENFD in Skin Punch Biopsies at Month 15E | -1.1 fibers/mm | Standard Deviation 3.51 |
Secondary
Change From Baseline in Intraepidermal Nerve Fiber Density (IENFD) in Skin Punch Biopsies at Month 9
IENFD was evaluated in peripheral skin punch biopsies from the distal part of lower extremities. IENFD was measured by counting the number of fibers and fiber branches that independently crossed the dermal-epidermal barrier (basement membrane). Secondary branching was excluded from quantification and fragments were not counted. The length of the histology section was measured (mm) and the linear epidermal nerve fiber density was reported as number of intraepidermal nerve fibers/mm.
Time frame: Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Population: Analysis population included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Intraepidermal Nerve Fiber Density (IENFD) in Skin Punch Biopsies at Month 9 | -0.4 fibers/mm | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Intraepidermal Nerve Fiber Density (IENFD) in Skin Punch Biopsies at Month 9 | -0.2 fibers/mm | Standard Deviation 2.72 |
Secondary
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6 | 0.021 millisecond (ms) |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6 | -0.020 millisecond (ms) |
95% CI: [-0.005, 0.088]Mixed Models Analysis
Secondary
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase.
Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E | Month 9E (Month 9 in the Active Therapy Extension Phase) | 0.006 millisecond (ms) | Standard Deviation 0.1109 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E | Month 15E (Month 15 in the Active Therapy Extension Phase) | 0.024 millisecond (ms) | Standard Deviation 0.1044 |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E | Month 9E (Month 9 in the Active Therapy Extension Phase) | 0.056 millisecond (ms) | Standard Deviation 0.1694 |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E | Month 15E (Month 15 in the Active Therapy Extension Phase) | 0.017 millisecond (ms) | Standard Deviation 0.2339 |
Secondary
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6 | -0.030 millisecond (ms) |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6 | -0.024 millisecond (ms) |
95% CI: [-0.065, 0.053]Mixed Models Analysis
Secondary
Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E
High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.
Time frame: Baseline, Months 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase.
Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E | Month 9E (Month 9 in the Active Therapy Extension Phase) | 0.010 millisecond (ms) | Standard Deviation 0.1233 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E | Month 15E (Month 15 in the Active Therapy Extension Phase) | 0.051 millisecond (ms) | Standard Deviation 0.1188 |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E | Month 9E (Month 9 in the Active Therapy Extension Phase) | -0.033 millisecond (ms) | Standard Deviation 0.2448 |
| Placebo | Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E | Month 15E (Month 15 in the Active Therapy Extension Phase) | 0.034 millisecond (ms) | Standard Deviation 0.2224 |
Secondary
Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E
SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.
Time frame: Baseline, Month 3E, 6E, 9E, 12E and 15E (Month 3, 6, 9, 12 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase.
Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Baseline | 69.7 Units on a scale | Standard Deviation 31.56 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 3E | -41.7 Units on a scale | Standard Deviation 33.98 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 6E | -38.0 Units on a scale | Standard Deviation 29.88 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 9E | -38.7 Units on a scale | Standard Deviation 29.9 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 12E | -41.6 Units on a scale | Standard Deviation 29.67 |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 15E | -44.6 Units on a scale | Standard Deviation 28.51 |
| Placebo | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 12E | -48.9 Units on a scale | Standard Deviation 34.77 |
| Placebo | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Baseline | 69.6 Units on a scale | Standard Deviation 29.59 |
| Placebo | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 9E | -46.6 Units on a scale | Standard Deviation 34.14 |
| Placebo | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 3E | -38.7 Units on a scale | Standard Deviation 33.49 |
| Placebo | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 15E | -49.9 Units on a scale | Standard Deviation 34.4 |
| Placebo | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Change at Month 6E | -43.4 Units on a scale | Standard Deviation 34.13 |
Secondary
Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9
SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss.
Time frame: Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Population: Analysis population included all randomized participants taking at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Month 3 | -23.0 Units on a scale |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Month 6 | -35.2 Units on a scale |
| Ritlecitinib 200/50 mg QD | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Month 9 | -38.2 Units on a scale |
| Placebo | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Month 3 | -2.7 Units on a scale |
| Placebo | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Month 6 | -5.1 Units on a scale |
| Placebo | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Month 9 | -6.8 Units on a scale |
Secondary
Change From Baseline in Percentage of IENFs With Axonal Swelling in Skin Punch Biopsies at Month 15E
The endpoint axonal dystrophy referred to the percentage of IENF with axonal swellings. Axonal swellings were evaluated in peripheral skin punch biopsies from the distal part of lower extremities. Axonal swellings were counted by axon. Any IENF with single or multiple swellings was counted as a single event, ie, a single axon with axonal swellings. For each participant, data were reported as the percentage of IENF with any number of swellings.
Time frame: Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Population: Overall number of participants analyzed included all participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Percentage of IENFs With Axonal Swelling in Skin Punch Biopsies at Month 15E | 0 Percentage of Nerve Fibers |
| Placebo | Change From Baseline in Percentage of IENFs With Axonal Swelling in Skin Punch Biopsies at Month 15E | 0 Percentage of Nerve Fibers |
Secondary
Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9
The endpoint axonal dystrophy referred to the percentage of IENF with axonal swellings. Axonal swellings were evaluated in peripheral skin punch biopsies from the distal part of lower extremities. Axonal swellings were counted by axon. Any IENF with single or multiple swellings was counted as a single event, ie, a single axon with axonal swellings. For each participant, data were reported as the percentage of IENF with any number of swellings. IENF was assessed at Day 1 and Month 9. Participants who had entered the Active Therapy Extension Phase at Month 6 had a skin punch biopsy taken at Month 6 for IENF assessments instead of at Month 9. The skin biopsy was collected before the start of Active Therapy Extension Phase.
Time frame: Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Population: Analysis population included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9 | 0.0 Percentage of Nerve Fibers |
| Placebo | Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9 | 0.0 Percentage of Nerve Fibers |
Secondary
Number of Participants Who Discontinued From Study Due to Adverse Event (AEs)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator.
Time frame: Approximately 16 months
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to All-Causality AEs | 0 Participants |
| Placebo | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to All-Causality AEs | 0 Participants |
| Placebo | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to All-Causality AEs | 1 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued From Study Due to Adverse Event (AEs) | Due to All-Causality AEs | 0 Participants |
Secondary
Number of Participants Who Discontinued From Study Due to AEs: Extension Phase (TP3)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator.
Time frame: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants Who Discontinued From Study Due to AEs: Extension Phase (TP3) | 1 Participants |
Secondary
Number of Participants Who Discontinued Study Drug Due to AE and Continued Study
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This Outcome Measures presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator.
Time frame: Approximately 16 months
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to All-Causality AEs | 1 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to Treatment-Related AEs | 0 Participants |
| Placebo | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to Treatment-Related AEs | 0 Participants |
| Placebo | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to All-Causality AEs | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to All-Causality AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Due to All-Causality AEs | 0 Participants |
Secondary
Number of Participants Who Discontinued Study Drug Due to AE and Continued Study: Extension Phase (TP3)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This outcome measure presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator.
Time frame: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study: Extension Phase (TP3) | 0 Participants |
Secondary
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E
Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. All participants had Wave V on BAEP present at stimulus intensities ranging from 80 dB to 40 dB up to Month 15E except for 1 participant. At Month 9 (TP1), 1 participant in 200/50/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. Fluctuations were seen in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6 on the right side.
Time frame: Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 70 dB nHL | 0 Participants |
Secondary
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9
Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level.
Time frame: Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Baseline - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 6 - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9 | Month 9 - 50 dB nHL | 0 Participants |
Secondary
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E
Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized using number of participants by treatment group at each intensity level. All participants had Wave V on BAEP present at stimulus intensities ranging from 80 dB to 40 dB up to Month 15E except for 1 participant. At Month 9 (TP1), 1 participant in 200/50/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. Fluctuations were seen in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6 on the right side.
Time frame: Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 50 dB nHL | 1 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 40 dB nHL | 1 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Baseline - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 3E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 6E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 9E - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E | Month 15E - 50 dB nHL | 0 Participants |
Secondary
Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9
Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB were summarized descriptively using number of participants by treatment group at each intensity level. At Month 9, 1 participant in 200/50 mg had absence of Wave V on BAEP at a stimulus intensity of 40 dB on the right side. The event was unilateral and showed fluctuations in the presence or absence of Wave V at various intensities on repeat assessments starting at Month 6.
Time frame: Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
Population: Analysis population included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 40 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 80 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 70 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 50 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 60 dB nHL | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 40 dB nHL | 1 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 80 dB of normal hearing level (nHL) | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 80 dB of normal hearing level (nHL) | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Baseline - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 50 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 6 - 40 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 80 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 70 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 60 dB nHL | 0 Participants |
| Placebo | Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9 | Month 9 - 50 dB nHL | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Safety laboratory assessments included the categories of Hematology, Chemistry, Urinalysis and other tests. The clinical significance was determined by the investigator.
Time frame: Approximately 16 months
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values: Extension Phase (TP3)
Safety laboratory assessments included the categories of hematology, chemistry, urinalysis and other tests. The clinical significance was determined by the investigator.
Time frame: From screening up to 28 days after last dose of study treatment (maximum up to 19 months)
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values: Extension Phase (TP3) | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator.
Time frame: Approximately 16 months
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Vital Signs: Extension Phase (TP3)
Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants were refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator.
Time frame: From screening up to 28 days follow up after last dose of study treatment (maximum up to 19 months)
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Clinically Significant Abnormalities in Vital Signs: Extension Phase (TP3) | 0 Participants |
Secondary
Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9
The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, Since the start of the study, my alopecia areata has: …. The participants selected one of seven responses ranging from greatly improved to greatly worsened. This Outcome Measure presented the number of participants with PGI-C response which was defined as greatly improved or moderately improved. Participants with missing PGI-C scores were considered as non-responders.
Time frame: Months 1, 3, 6 and 9
Population: Analysis population included all randomized participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 1 | 4 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 3 | 20 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 6 | 21 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 9 | 19 Participants |
| Placebo | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 9 | 6 Participants |
| Placebo | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 1 | 3 Participants |
| Placebo | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 6 | 10 Participants |
| Placebo | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Month 3 | 6 Participants |
Secondary
Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E
The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, Since the start of the study, my alopecia areata has: …. The participants selected one of seven responses ranging from greatly improved to greatly worsened. This Outcome Measure presented the number of participants with PGI-C response which was defined as greatly improved or moderately improved. Participants with missing PGI-C scores were considered as non-responders.
Time frame: Month 3E, 6E, 9E, 12E and 15E
Population: Analysis population included all randomized participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 9E | 20 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 12E | 17 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 6E | 16 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 15E | 17 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 3E | 22 Participants |
| Placebo | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 15E | 18 Participants |
| Placebo | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 3E | 22 Participants |
| Placebo | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 6E | 20 Participants |
| Placebo | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 12E | 18 Participants |
| Placebo | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 9E | 18 Participants |
Secondary
Number of Participants With TEAEs and TESAEs: Extension Phase (TP3)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of SAE. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator.
Time frame: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With TEAEs and TESAEs: Extension Phase (TP3) | TEAEs | 19 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With TEAEs and TESAEs: Extension Phase (TP3) | TESAEs | 1 Participants |
Secondary
Number of Participants With Temporary Drug Discontinuation Due to AEs
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator.
Time frame: Approximately 16 months
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to All-Causality AEs | 6 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to Treatment-Related AEs | 3 Participants |
| Placebo | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to Treatment-Related AEs | 0 Participants |
| Placebo | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to All-Causality AEs | 1 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to All-Causality AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to Treatment-Related AEs | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Temporary Drug Discontinuation Due to AEs | Due to All-Causality AEs | 0 Participants |
Secondary
Number of Participants With Temporary Drug Discontinuation Due to AEs: Extension Phase (TP3)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator.
Time frame: From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months)
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Temporary Drug Discontinuation Due to AEs: Extension Phase (TP3) | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator.
Time frame: Approximately 16 months
Population: Analysis population included all participants taking at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ritlecitinib 200/50 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (All-Causality) | 29 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (Treatment-Related) | 9 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (Treatment-Related) | 0 Participants |
| Ritlecitinib 200/50 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (All-Causality) | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (Treatment-Related) | 5 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (Treatment-Related) | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (All-Causality) | 22 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (All-Causality) | 1 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (All-Causality) | 1 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (All-Causality) | 3 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (Treatment-Related) | 0 Participants |
| Ritlecitinib 50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (Treatment-Related) | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (Treatment-Related) | 0 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (All-Causality) | 3 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAE (Treatment-Related) | 1 Participants |
| Ritlecitinib 200/50 mg QD - Active Therapy Extension Phase | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAE (All-Causality) | 0 Participants |