Trial Outcomes & Findings for Ritlecitinib for Cicatricial Alopecia (NCT NCT05549934)
NCT ID: NCT05549934
Last Updated: 2026-07-15
Results Overview
Log-fold Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene
COMPLETED
PHASE2
50 participants
Baseline to Week 24
2026-07-15
Participant Flow
Participant milestones
| Measure |
PF-06651600 (Ritlecitinib)
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
PF-06651600 (Ritlecitinib)
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lack of Satisfaction
|
1
|
|
Overall Study
Not Reported
|
1
|
Baseline Characteristics
Ritlecitinib for Cicatricial Alopecia
Baseline characteristics by cohort
| Measure |
PF-06651600 (Ritlecitinib)
n=50 Participants
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Age, Continuous
|
48.72 years
STANDARD_DEVIATION 13.41 • n=20 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Data results for participants who provided data.
Log-fold Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene
Outcome measures
| Measure |
PF-06651600 (Ritlecitinib)
n=34 Participants
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Change in Ct Values of mRNA Levels of CCL5 Gene
|
-1.11 amplification cycles
Standard Error 0.225
|
PRIMARY outcome
Timeframe: Week 48Population: Data for participants who experienced an AE
The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormalities in laboratory parameters.
Outcome measures
| Measure |
PF-06651600 (Ritlecitinib)
n=43 Participants
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Number of Treatment-Emergent Adverse Events
|
60 events
|
SECONDARY outcome
Timeframe: Baseline, Week 24, and Week 48Population: Data results for participants who provided data at timepoints
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline from a total score of 0-84, with higher score indicating more severity. Percent change in FFASI at Week 24 and Week 48 as compared to baseline.
Outcome measures
| Measure |
PF-06651600 (Ritlecitinib)
n=50 Participants
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Percent Change in the Frontal Fibrosis Alopecia Severity Index (FFASI)
Week 24
|
-27.6 Percent change in score on a scale
Standard Error 4.6
|
|
Percent Change in the Frontal Fibrosis Alopecia Severity Index (FFASI)
Week 48
|
-51.3 Percent change in score on a scale
Standard Error 6.7
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: Data results for participants who provided data at timepoints.
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity. Percent change in the LPPAI at Week 24 and Week 48 as compared to baseline.
Outcome measures
| Measure |
PF-06651600 (Ritlecitinib)
n=50 Participants
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Percent Change in the Lichen Planopilaris Activity Index (LPPAI)
Week 24
|
-57.9 Percent change in score on a scale
Standard Error 5.9
|
|
Percent Change in the Lichen Planopilaris Activity Index (LPPAI)
Week 48
|
-69.9 Percent change in score on a scale
Standard Error 3.8
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: Data results for participants who provided data at timepoints.
Percent change in Central Hair Loss Grade (CHLG) is an ordinal photographic outcome derived from a validated central scalp alopecia photographic scale to capture the pattern and severity of central hair loss. The scale uses standardized photographs and grades severity from 0 to 5, with 0 representing no hair loss, grades 1 and 2 representing early hair loss, and grades 3 to 5 representing probable CCCA with increasing severity.
Outcome measures
| Measure |
PF-06651600 (Ritlecitinib)
n=50 Participants
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Percentage Change From Baseline in Change in Central Hair Loss Grade (CHLG)
Week 24
|
-24.4 Percent change in score on a scale
Standard Error 7.8
|
|
Percentage Change From Baseline in Change in Central Hair Loss Grade (CHLG)
Week 48
|
-46.9 Percent change in score on a scale
Standard Error 12.4
|
Adverse Events
PF-06651600 (Ritlecitinib)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06651600 (Ritlecitinib)
n=50 participants at risk
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
|
|---|---|
|
Skin and Subcutaneous Tissue Disorders
Urticaria/Hives
|
2.0%
1/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Lymphopenia
|
28.0%
14/50 • 48 Weeks
|
|
Gastrointestinal Disorders
Elevated Liver Enzyme
|
4.0%
2/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Elevated AST
|
2.0%
1/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Decreased White Blood Cell Count
|
4.0%
2/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Anemia
|
4.0%
2/50 • 48 Weeks
|
|
Infections and Infestations
Oral Herpes Symplex
|
2.0%
1/50 • 48 Weeks
|
|
Infections and Infestations
Upper Respiratory Infection
|
4.0%
2/50 • 48 Weeks
|
|
Infections and Infestations
Nasopharyngitis
|
2.0%
1/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Elevated CPK
|
38.0%
19/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Leukopenia
|
12.0%
6/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Lymphocytopenia
|
16.0%
8/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Lymphocytopenia <500
|
4.0%
2/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Neutropenia
|
14.0%
7/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Neutropenia <1
|
2.0%
1/50 • 48 Weeks
|
|
Blood and Lymphatic System Disorders
Thrombocytopenia
|
4.0%
2/50 • 48 Weeks
|
|
General Disorders
Weight Gain
|
2.0%
1/50 • 48 Weeks
|
|
Ear and Labyrinth Disorders
Tinnitus
|
2.0%
1/50 • 48 Weeks
|
|
Gastrointestinal Disorders
Diarrrhea
|
4.0%
2/50 • 48 Weeks
|
|
General Disorders
Fatigue
|
10.0%
5/50 • 48 Weeks
|
|
General Disorders
Headaches
|
4.0%
2/50 • 48 Weeks
|
|
General Disorders
Restless Leg Syndrome
|
2.0%
1/50 • 48 Weeks
|
|
Renal and Urinary Disorders
Acute Kidney Injury
|
2.0%
1/50 • 48 Weeks
|
|
Skin and Subcutaneous Tissue Disorders
Acne
|
4.0%
2/50 • 48 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60