Clinical Trials List
Protocol NumberB7981094
NCT Number(ClinicalTrials.gov Identfier)NCT06873945
Active
2025-06-15 - 2027-04-17
Phase III
Recruiting5
ICD-10L63.2
Ophiasis
ICD-10L63.8
Other alopecia areata
ICD-10L63.9
Alopecia areata, unspecified
ICD-9704.01
Alopecia areata
A phase 3, external and synthetic placebo-controlled randomized trial, with dose escalation in non-responders, investigated the safety and efficacy of RITLECITINIB 50 mg and 100 mg once daily in adults and adolescents aged 12 years and older with alopecia areata.
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Sponsor
Pfizer Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/24
Investigators and Locations
Co-Principal Investigator
- 陳柏樺 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yun-Ting Chang 無
- DINGDAR LEE 無
- 吳貞宜 無
- Cheng-Yuan Li 無
- 何翊芯 無
- 廖文輝 無
- 馬聖翔 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Sheng Yiao Lin 無
- 陳盈君 無
- Yang-Yi Chen 無
- Ling-Feng Wang 無
- Ting-Ting Yang 無
- 邱莉雯 無
- 王暉景 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wen-Hung Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Suitable for treating patients aged 12 years and older with severe alopecia areata.
Objectives
To study the efficacy and safety of ritlecitinib 100 mg QD dose. The approved 50 mg QD dose was included in the trial as a reference to allow comparison of the 100 mg and 50 mg QD doses.
Test Drug
Ritlecitinib
Active Ingredient
Ritlecitinib Tosylate
Dosage Form
Capsules
Dosage
50 mg/100mg
Endpoints
Comparing the efficacy of ritlecitinib 100 mg QD with placebo on scalp hair regrowth.
Inclution Criteria
To be eligible to participate in this trial, participants must meet all of the following inclusion criteria:
Age:
1. Participants must be 18 years of age or older at the time of screening (or the minimum consent age as required by local regulations).
Disease Characteristics:
2. Participants must meet the following criteria for Alopecia Areata (AA) at both the screening and baseline periods:
a. Clinically diagnosed with AA, with no other cause of hair loss.
b. ≥50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT), with no evidence of regrowth of terminal hair in the past 6 months.
• Photographs taken at screening must be submitted to a designated person of the trial commissioner to verify a SALT score ≥50 and that the hair loss is caused by AA. Participants must not be randomly assigned until verification is confirmed.
c. Current hair loss episodes ≤10 years.
Age:
1. Participants must be 18 years of age or older at the time of screening (or the minimum consent age as required by local regulations).
Disease Characteristics:
2. Participants must meet the following criteria for Alopecia Areata (AA) at both the screening and baseline periods:
a. Clinically diagnosed with AA, with no other cause of hair loss.
b. ≥50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT), with no evidence of regrowth of terminal hair in the past 6 months.
• Photographs taken at screening must be submitted to a designated person of the trial commissioner to verify a SALT score ≥50 and that the hair loss is caused by AA. Participants must not be randomly assigned until verification is confirmed.
c. Current hair loss episodes ≤10 years.
Exclusion Criteria
Subjects will be excluded from this trial if they meet any of the following criteria: Medical Conditions:
1. Diseases or conditions affecting hair loss, including:
• Other types of hair loss (including, but not limited to, traction and scarring alopecia, stress-related alopecia). Participants known to have androgenetic alopecia will be excluded.
• Other scalp conditions that may affect AA assessment (e.g., psoriasis scalp, dermatitis, etc.).
• Active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.).
2. History of severe or anaphylactic allergic reactions to any kinase inhibitor, or known allergy/anaphylactic reaction to any component (including excipients) of the trial intervention.
3. Any mental illness meeting one of the following criteria, including recent or current suicidal ideation or behavior:
• Suicidal ideation with actual intent, method, or plan within the past year: Answer "Yes" to item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening follow-up.
• A record of suicidal behavior within the past 5 years: Answer "Yes" to any item on the C-SSRS related to suicidal behavior (related to an event that occurred within the past 5 years).
• For adults, any record of serious or recurrent suicidal behavior in their lifetime. For adolescents, any record of suicidal behavior in their past lifetime.
4. General history of infection:
• Within the 3 months prior to Day 1, a history of hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal) for a systemic infection, or a condition deemed clinically significant by the trial administrator.
• Within 4 weeks prior to Day 1, participants must have had an active acute or chronic skin infection requiring treatment with oral antibiotics, antiviral agents, antiparasitic agents, antiprotozoal agents, or antifungal agents. Note: Participants may be re-screened after recovery from the infection.
• Evidence or history of untreated, currently treated, or inappropriately treated open or latent Mycobacterium tuberculosis (TB) infection.
5. History of specific viral infections:
• History of (single episode) disseminated herpes zoster or disseminated herpes simplex, or recurrent (more than one episode) localized, dermatomal herpes zoster.
• Hepatitis B and C virus infection: All participants will undergo hepatitis B and hepatitis C screening to confirm eligibility.
○ Hepatitis B: During screening, hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) tests will be performed:
▪ If both tests are negative, the participant is eligible for trial inclusion.
▪ If the HBsAg test result is positive, the participant must be excluded from the trial.
▪ If the HBsAg test result is negative and the HBcAb test result is positive, a reflex test for hepatitis B surface antibody (HBsAb) must be performed:
a. If the HBsAb test result is negative, the participant must be excluded from the trial;
b. If the HBsAb test result is positive, the participant is eligible for trial inclusion.
○ Hepatitis C: During screening, Hepatitis C Antibody (HCVAb) testing will be performed:
▪ Subjects with a negative HCVAb test result are eligible.
▪ Subjects with a positive HCVAb test result will undergo further HCV RNA testing. Subjects with positive HCVAb and HCV RNA test results are not eligible to participate in this trial.
• Known immunodeficiency disease (including a positive Human Immunodeficiency Virus (HIV) serological test at screening), or a first-degree relative with a hereditary immunodeficiency (unless known to be a negative carrier).
6. Other medical conditions:
• Gradual hearing loss, sudden hearing loss, or middle or inner ear disease within the past 5 years, such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other hearing conditions considered acute, fluctuating, or progressive.
• Abnormal findings on chest imaging (e.g., chest X-ray) screening, including but not limited to signs of open TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to screening, and formal interpretation must be provided in the original documentation.
• Any malignancy or a history of malignancy, except for non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin that has been appropriately treated or removed, or cervical carcinoma in situ.
• Any history of lymphoproliferative disorders (such as Epstein-Barr Virus (EBV)-associated lymphoproliferative disorder), lymphoma, leukemia, or signs and symptoms indicating current lymphatic or lymphatic system disease.
• Major trauma or major surgery within one month prior to receiving the first dose of the investigational drug, or being deemed to require urgent surgery. Subjects scheduled for elective surgery during the trial may only participate with the approval of the trial commissioner.
7. Any abnormal medical or laboratory test results that may increase the risk of participating in the trial, or a situation where the trial administrator determines that the subject is unsuitable to participate in the trial.
1. Diseases or conditions affecting hair loss, including:
• Other types of hair loss (including, but not limited to, traction and scarring alopecia, stress-related alopecia). Participants known to have androgenetic alopecia will be excluded.
• Other scalp conditions that may affect AA assessment (e.g., psoriasis scalp, dermatitis, etc.).
• Active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.).
2. History of severe or anaphylactic allergic reactions to any kinase inhibitor, or known allergy/anaphylactic reaction to any component (including excipients) of the trial intervention.
3. Any mental illness meeting one of the following criteria, including recent or current suicidal ideation or behavior:
• Suicidal ideation with actual intent, method, or plan within the past year: Answer "Yes" to item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening follow-up.
• A record of suicidal behavior within the past 5 years: Answer "Yes" to any item on the C-SSRS related to suicidal behavior (related to an event that occurred within the past 5 years).
• For adults, any record of serious or recurrent suicidal behavior in their lifetime. For adolescents, any record of suicidal behavior in their past lifetime.
4. General history of infection:
• Within the 3 months prior to Day 1, a history of hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal) for a systemic infection, or a condition deemed clinically significant by the trial administrator.
• Within 4 weeks prior to Day 1, participants must have had an active acute or chronic skin infection requiring treatment with oral antibiotics, antiviral agents, antiparasitic agents, antiprotozoal agents, or antifungal agents. Note: Participants may be re-screened after recovery from the infection.
• Evidence or history of untreated, currently treated, or inappropriately treated open or latent Mycobacterium tuberculosis (TB) infection.
5. History of specific viral infections:
• History of (single episode) disseminated herpes zoster or disseminated herpes simplex, or recurrent (more than one episode) localized, dermatomal herpes zoster.
• Hepatitis B and C virus infection: All participants will undergo hepatitis B and hepatitis C screening to confirm eligibility.
○ Hepatitis B: During screening, hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) tests will be performed:
▪ If both tests are negative, the participant is eligible for trial inclusion.
▪ If the HBsAg test result is positive, the participant must be excluded from the trial.
▪ If the HBsAg test result is negative and the HBcAb test result is positive, a reflex test for hepatitis B surface antibody (HBsAb) must be performed:
a. If the HBsAb test result is negative, the participant must be excluded from the trial;
b. If the HBsAb test result is positive, the participant is eligible for trial inclusion.
○ Hepatitis C: During screening, Hepatitis C Antibody (HCVAb) testing will be performed:
▪ Subjects with a negative HCVAb test result are eligible.
▪ Subjects with a positive HCVAb test result will undergo further HCV RNA testing. Subjects with positive HCVAb and HCV RNA test results are not eligible to participate in this trial.
• Known immunodeficiency disease (including a positive Human Immunodeficiency Virus (HIV) serological test at screening), or a first-degree relative with a hereditary immunodeficiency (unless known to be a negative carrier).
6. Other medical conditions:
• Gradual hearing loss, sudden hearing loss, or middle or inner ear disease within the past 5 years, such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other hearing conditions considered acute, fluctuating, or progressive.
• Abnormal findings on chest imaging (e.g., chest X-ray) screening, including but not limited to signs of open TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to screening, and formal interpretation must be provided in the original documentation.
• Any malignancy or a history of malignancy, except for non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin that has been appropriately treated or removed, or cervical carcinoma in situ.
• Any history of lymphoproliferative disorders (such as Epstein-Barr Virus (EBV)-associated lymphoproliferative disorder), lymphoma, leukemia, or signs and symptoms indicating current lymphatic or lymphatic system disease.
• Major trauma or major surgery within one month prior to receiving the first dose of the investigational drug, or being deemed to require urgent surgery. Subjects scheduled for elective surgery during the trial may only participate with the approval of the trial commissioner.
7. Any abnormal medical or laboratory test results that may increase the risk of participating in the trial, or a situation where the trial administrator determines that the subject is unsuitable to participate in the trial.
The Estimated Number of Participants
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Taiwan
19 participants
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Global
550 participants
