Trial Outcomes & Findings for Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia (NCT NCT05076006)
NCT ID: NCT05076006
Last Updated: 2026-05-19
Results Overview
The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormal in laboratory parameters. Incidence and Severity of
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Week 48
Results posted on
2026-05-19
Participant Flow
Participant milestones
| Measure |
FFA Placebo Then Brepocitinib
Participants with fibrosing alopecia (FFA) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
FFA Brepocitinib
Participants with fibrosing alopecia (FFA) brepocitinib 45 mg
|
LPP Placebo Then Brepocitinib
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
LPP Brepocitinib
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo Then Brepocitinib
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
CCCA Brepocitinib
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Randomization - 24 Weeks
STARTED
|
4
|
5
|
3
|
13
|
6
|
20
|
|
Randomization - 24 Weeks
COMPLETED
|
4
|
5
|
3
|
13
|
5
|
19
|
|
Randomization - 24 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Open Label 24 Weeks
STARTED
|
4
|
5
|
3
|
13
|
5
|
19
|
|
Open Label 24 Weeks
COMPLETED
|
4
|
5
|
3
|
13
|
5
|
19
|
|
Open Label 24 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FFA Placebo Then Brepocitinib
Participants with fibrosing alopecia (FFA) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
FFA Brepocitinib
Participants with fibrosing alopecia (FFA) brepocitinib 45 mg
|
LPP Placebo Then Brepocitinib
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
LPP Brepocitinib
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo Then Brepocitinib
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
CCCA Brepocitinib
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Randomization - 24 Weeks
did not meet inclusion/exclusion criteria
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Data for participants with FFA only
Baseline characteristics by cohort
| Measure |
FFA Placebo Then Brepocitinib
n=4 Participants
Participants with fibrosing alopecia (FFA) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
FFA Brepocitinib
n=5 Participants
Participants with fibrosing alopecia (FFA) brepocitinib 45 mg
|
LPP Placebo Then Brepocitinib
n=3 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
LPP Brepocitinib
n=13 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo Then Brepocitinib
n=5 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks, then 24 weeks of brepocitinib 45mg
|
CCCA Brepocitinib
n=19 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 6 • n=4 Participants
|
57 years
STANDARD_DEVIATION 9 • n=5 Participants
|
58 years
STANDARD_DEVIATION 16 • n=3 Participants
|
51 years
STANDARD_DEVIATION 17 • n=13 Participants
|
55 years
STANDARD_DEVIATION 14 • n=5 Participants
|
54 years
STANDARD_DEVIATION 13 • n=19 Participants
|
53 years
STANDARD_DEVIATION 13 • n=49 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
11 Participants
n=13 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=19 Participants
|
47 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=13 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
18 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=19 Participants
|
27 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=49 Participants
|
|
FFASI
|
62 units on a scale
STANDARD_DEVIATION 16 • n=4 Participants • Data for participants with FFA only
|
45 units on a scale
STANDARD_DEVIATION 13 • n=5 Participants • Data for participants with FFA only
|
—
|
—
|
—
|
—
|
52 units on a scale
STANDARD_DEVIATION 16 • n=9 Participants • Data for participants with FFA only
|
|
LPPAI
|
—
|
—
|
6.00 units on a scale
STANDARD_DEVIATION 2.60 • n=3 Participants • Data only for participants with LPP.
|
4.54 units on a scale
STANDARD_DEVIATION 1.91 • n=13 Participants • Data only for participants with LPP.
|
—
|
—
|
4.82 units on a scale
STANDARD_DEVIATION 2.04 • n=16 Participants • Data only for participants with LPP.
|
|
CHLG
|
—
|
—
|
—
|
—
|
3.40 units on a scale
STANDARD_DEVIATION 1.14 • n=5 Participants • Data only for participants with CCCA
|
3.74 units on a scale
STANDARD_DEVIATION 0.87 • n=19 Participants • Data only for participants with CCCA
|
3.67 units on a scale
STANDARD_DEVIATION 0.92 • n=24 Participants • Data only for participants with CCCA
|
|
Eyebrow Score
|
1.50 units on a scale
STANDARD_DEVIATION 0.58 • n=4 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 1.73 • n=3 Participants
|
2.62 units on a scale
STANDARD_DEVIATION 1.19 • n=13 Participants
|
2.60 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
2.74 units on a scale
STANDARD_DEVIATION 0.87 • n=19 Participants
|
2.53 units on a scale
STANDARD_DEVIATION 1.06 • n=49 Participants
|
|
Eyelash Score
|
2.50 units on a scale
STANDARD_DEVIATION 0.58 • n=4 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
3.67 units on a scale
STANDARD_DEVIATION 0.58 • n=3 Participants
|
3.08 units on a scale
STANDARD_DEVIATION 1.12 • n=13 Participants
|
2.60 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
2.89 units on a scale
STANDARD_DEVIATION 0.81 • n=19 Participants
|
2.94 units on a scale
STANDARD_DEVIATION 0.92 • n=49 Participants
|
|
DLQI
|
12.75 units on a scale
STANDARD_DEVIATION 2.99 • n=4 Participants
|
16.00 units on a scale
STANDARD_DEVIATION 4.18 • n=5 Participants
|
13.7 units on a scale
STANDARD_DEVIATION 1.5 • n=3 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 5.2 • n=13 Participants
|
18.2 units on a scale
STANDARD_DEVIATION 9.01 • n=5 Participants
|
15.89 units on a scale
STANDARD_DEVIATION 7.25 • n=19 Participants
|
16.81 units on a scale
STANDARD_DEVIATION 6.36 • n=49 Participants
|
|
Disease Duration
|
6.00 years
STANDARD_DEVIATION 0.82 • n=4 Participants
|
4.00 years
STANDARD_DEVIATION 2.35 • n=5 Participants
|
2.67 years
STANDARD_DEVIATION 2.08 • n=3 Participants
|
4.15 years
STANDARD_DEVIATION 1.77 • n=13 Participants
|
3.40 years
STANDARD_DEVIATION 1.82 • n=5 Participants
|
4.05 years
STANDARD_DEVIATION 1.65 • n=19 Participants
|
4.08 years
STANDARD_DEVIATION 1.8 • n=49 Participants
|
PRIMARY outcome
Timeframe: Week 48The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormal in laboratory parameters. Incidence and Severity of
Outcome measures
| Measure |
Placebo
n=12 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=49 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in CCL5 Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
-1.05 cycle threshold (Ct)
Standard Deviation 2.23
|
-2.24 cycle threshold (Ct)
Standard Deviation 1.42
|
-1.38 cycle threshold (Ct)
Standard Deviation 1.1
|
-1.51 cycle threshold (Ct)
Standard Deviation 1.21
|
0.3 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
-0.29 cycle threshold (Ct)
Standard Deviation 0.75
|
|
Changes From Baseline in CCL5 Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
1.9 cycle threshold (Ct)
Standard Deviation 2.79
|
-1.52 cycle threshold (Ct)
Standard Deviation 1.3
|
-1.32 cycle threshold (Ct)
Standard Deviation 1.0
|
-0.89 cycle threshold (Ct)
Standard Deviation 1.5
|
0.66 cycle threshold (Ct)
Standard Deviation 1.21
|
-0.67 cycle threshold (Ct)
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of CXCR3(TGFB1) gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in CXCR3(TGFB1) Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
0.25 cycle threshold (Ct)
Standard Deviation 0.98
|
0.03 cycle threshold (Ct)
Standard Deviation 0.16
|
-0.06 cycle threshold (Ct)
Standard Deviation 0.06
|
-0.2 cycle threshold (Ct)
Standard Deviation 0.78
|
0.27 cycle threshold (Ct)
Standard Deviation 1.15
|
0.34 cycle threshold (Ct)
Standard Deviation 0.74
|
|
Changes From Baseline in CXCR3(TGFB1) Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
-0.33 cycle threshold (Ct)
Standard Deviation 0.65
|
-0.16 cycle threshold (Ct)
Standard Deviation 0.34
|
-0.19 cycle threshold (Ct)
Standard Deviation 0.0
|
-0.61 cycle threshold (Ct)
Standard Deviation 0.59
|
0.12 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
0.87 cycle threshold (Ct)
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of IFN-γ gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in IFN-γ Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
2.33 cycle threshold (Ct)
Standard Deviation 2.26
|
-1.74 cycle threshold (Ct)
Standard Deviation 0.91
|
-0.35 cycle threshold (Ct)
Standard Deviation 0.68
|
-1.47 cycle threshold (Ct)
Standard Deviation 1.63
|
0.97 cycle threshold (Ct)
Standard Deviation 0.87
|
-0.09 cycle threshold (Ct)
Standard Deviation 3.09
|
|
Changes From Baseline in IFN-γ Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
-1.11 cycle threshold (Ct)
Standard Deviation 3.39
|
-2.05 cycle threshold (Ct)
Standard Deviation 1.29
|
-1.19 cycle threshold (Ct)
Standard Deviation 1.87
|
-2.05 cycle threshold (Ct)
Standard Deviation 2.53
|
2.27 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
-0.26 cycle threshold (Ct)
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of CXCL9 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in CXCL9 Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
3.14 cycle threshold (Ct)
Standard Deviation 5.42
|
-2.59 cycle threshold (Ct)
Standard Deviation 2.14
|
-1.03 cycle threshold (Ct)
Standard Deviation 2.0
|
-1.36 cycle threshold (Ct)
Standard Deviation 2.63
|
-0.19 cycle threshold (Ct)
Standard Deviation 1.18
|
-0.79 cycle threshold (Ct)
Standard Deviation 3.48
|
|
Changes From Baseline in CXCL9 Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
0.39 cycle threshold (Ct)
Standard Deviation 4.97
|
-2.86 cycle threshold (Ct)
Standard Deviation 1.58
|
-0.69 cycle threshold (Ct)
Standard Deviation 0.31
|
-2.11 cycle threshold (Ct)
Standard Deviation 2.75
|
-0.17 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
-1.52 cycle threshold (Ct)
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of CXCL10 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in CXCL10 Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
2.87 cycle threshold (Ct)
Standard Deviation 4.57
|
-2.94 cycle threshold (Ct)
Standard Deviation 1.64
|
-0.72 cycle threshold (Ct)
Standard Deviation 1.65
|
-1.75 cycle threshold (Ct)
Standard Deviation 2.26
|
0.27 cycle threshold (Ct)
Standard Deviation 2.84
|
-1.5 cycle threshold (Ct)
Standard Deviation 2.73
|
|
Changes From Baseline in CXCL10 Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
1.04 cycle threshold (Ct)
Standard Deviation 4.14
|
-2.73 cycle threshold (Ct)
Standard Deviation 2.44
|
-0.73 cycle threshold (Ct)
Standard Deviation 0.42
|
-2.37 cycle threshold (Ct)
Standard Deviation 2.56
|
-1.43 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
-1.28 cycle threshold (Ct)
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of IL-12RB1 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in IL-12RB1 Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
0.81 cycle threshold (Ct)
Standard Deviation 2.36
|
-0.66 cycle threshold (Ct)
Standard Deviation 1.61
|
-0.55 cycle threshold (Ct)
Standard Deviation 1.11
|
-0.77 cycle threshold (Ct)
Standard Deviation 1.46
|
0.45 cycle threshold (Ct)
Standard Deviation 1.72
|
-0.33 cycle threshold (Ct)
Standard Deviation 1.12
|
|
Changes From Baseline in IL-12RB1 Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
-1.38 cycle threshold (Ct)
Standard Deviation 1.94
|
0.11 cycle threshold (Ct)
Standard Deviation 2.13
|
-1.0 cycle threshold (Ct)
Standard Deviation 0.3
|
-1.18 cycle threshold (Ct)
Standard Deviation 1.02
|
-0.44 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
-0.11 cycle threshold (Ct)
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 48Population: data for participants with skin biopsies
mRNA Levels of STAT1 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=11 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=4 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=10 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in STAT1 Gene Expression Level in Response to PF-06700841
Baseline and Week 24
|
0.79 cycle threshold (Ct)
Standard Deviation 1.6
|
-0.7 cycle threshold (Ct)
Standard Deviation 0.32
|
0.12 cycle threshold (Ct)
Standard Deviation 1.01
|
-0.8 cycle threshold (Ct)
Standard Deviation 0.94
|
0.34 cycle threshold (Ct)
Standard Deviation 0.83
|
0.22 cycle threshold (Ct)
Standard Deviation 0.96
|
|
Changes From Baseline in STAT1 Gene Expression Level in Response to PF-06700841
Baseline and Week 48
|
-0.36 cycle threshold (Ct)
Standard Deviation 1.34
|
-0.38 cycle threshold (Ct)
Standard Deviation 0.91
|
0.03 cycle threshold (Ct)
Standard Deviation 0.22
|
-0.66 cycle threshold (Ct)
Standard Deviation 0.49
|
0.39 cycle threshold (Ct)
Standard Deviation NA
data for only one participant
|
0.06 cycle threshold (Ct)
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 48Population: Data for FFA participants
Mean Change in The Frontal Fibrosis Alopecia Severity Index (FFASI) at Week 12, Week 24 and Week 48 as compared to baseline The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. The scalp/head section is scored 0-84 with the second section (all other areas) scored 0-16. The sum of the scalp and other areas results in a total score 0-100, with higher score indicating more severity.
Outcome measures
| Measure |
Placebo
n=4 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Mean Change in The Frontal Fibrosis Alopecia Severity Index (FFASI) as Compared to Baseline
Week 12
|
1.25 score on a scale
Standard Error 2.87
|
-10.2 score on a scale
Standard Error 16.51
|
—
|
—
|
—
|
—
|
|
Mean Change in The Frontal Fibrosis Alopecia Severity Index (FFASI) as Compared to Baseline
Week 24
|
0.33 score on a scale
Standard Error 0.58
|
-15 score on a scale
Standard Error 24.99
|
—
|
—
|
—
|
—
|
|
Mean Change in The Frontal Fibrosis Alopecia Severity Index (FFASI) as Compared to Baseline
Week 48
|
-12.33 score on a scale
Standard Error 9.5
|
-17.4 score on a scale
Standard Error 23.99
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 48Population: Data for LPP participants
Mean Percent Change in The Lichen Planopilaris Activity Index (LPPAI) at Week 12, Week 24 and Week 48 as compared to baseline 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.
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=13 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in The Lichen Planopilaris Activity Index (LPPAI) as Compared to Baseline
Week 12
|
-1.28 mean percent change
Standard Error 0.83
|
-2.01 mean percent change
Standard Error 2.73
|
—
|
—
|
—
|
—
|
|
Mean Percent Change in The Lichen Planopilaris Activity Index (LPPAI) as Compared to Baseline
Week 24
|
-2.06 mean percent change
Standard Error 0.38
|
-2.4 mean percent change
Standard Error 2.15
|
—
|
—
|
—
|
—
|
|
Mean Percent Change in The Lichen Planopilaris Activity Index (LPPAI) as Compared to Baseline
Week 48
|
-3.67 mean percent change
Standard Error 2.36
|
-3.75 mean percent change
Standard Error 2.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: participants with CCCA with data for both timepoints.
The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss , 1 - minimal central scalp hair loss , 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss). Change in CHLG for participants with CCCA at Week 48 as compared to baseline
Outcome measures
| Measure |
Placebo
n=1 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=7 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Change in The Central Hair Loss Grade (CHLG)
|
-3 score on a scale
Standard Error NA
Data for one participant
|
-1.43 score on a scale
Standard Error 1.13
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 28Population: Data not collected
The PGA-I ranges from -4(significant worsening) to 4(significant improvement).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 48Population: data available for participants who completed questionnaire
DLQI is a questionnaire with quality of life indicators related to the health of the skin. This questionnaire has 10 items related to skin problems, each one with 4 possible answers: Very Much, A Lot, A Little, and Not at All. The sum of items scores will generate a score of how much the skin problem affects the personal life. Full score range from 0 to 30, with higher score indicating poorer health outcomes. Change at Week 48 as compared to baseline
Outcome measures
| Measure |
Placebo
n=3 Participants
Tablets without active ingredients
Placebo: placebo comparator
|
Brepocitinib
n=5 Participants
Brepocitinib is a dual inhibitor of JAK1 and tyrosine kinase (TYK) - e daily oral monotherapy 45mg
|
LPP Placebo
n=2 Participants
Participants with lichen planopilaris (LPP) Tablets without active ingredients for 24 weeks,
|
LPP Brepocitinib
n=10 Participants
Participants with lichen planopilaris (LPP) brepocitinib 45 mg
|
CCCA Placebo
n=1 Participants
Participants with cicatricial alopecia (CCCA) Tablets without active ingredients for 24 weeks,
|
CCCA Brepocitinib
n=7 Participants
Participants with cicatricial alopecia (CCCA) brepocitinib 45 mg
|
|---|---|---|---|---|---|---|
|
Absolute Change in the Dermatology Quality of Life Index (DLQI)
|
1.33 score on a scale
Standard Deviation 4.04
|
-2.6 score on a scale
Standard Deviation 3.13
|
-2 score on a scale
Standard Deviation 2.83
|
-4.6 score on a scale
Standard Deviation 4.45
|
-1 score on a scale
Standard Deviation NA
data for only one participant
|
-1.86 score on a scale
Standard Deviation 3.2
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Brepocitinib
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Tablets without active ingredients
|
Brepocitinib
n=37 participants at risk
Brepocitinib 45mg
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 48 weeks
|
2.7%
1/37 • 48 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/12 • 48 weeks
|
10.8%
4/37 • 48 weeks
|
|
Investigations
Blood level of creatine
|
0.00%
0/12 • 48 weeks
|
10.8%
4/37 • 48 weeks
|
|
Investigations
Elevated CPK
|
0.00%
0/12 • 48 weeks
|
2.7%
1/37 • 48 weeks
|
|
Investigations
Elevated liver enzymes
|
0.00%
0/12 • 48 weeks
|
5.4%
2/37 • 48 weeks
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • 48 weeks
|
2.7%
1/37 • 48 weeks
|
|
Renal and urinary disorders
Hematuria
|
8.3%
1/12 • 48 weeks
|
8.1%
3/37 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • 48 weeks
|
24.3%
9/37 • 48 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • 48 weeks
|
8.1%
3/37 • 48 weeks
|
|
Investigations
Weight Gain
|
0.00%
0/12 • 48 weeks
|
8.1%
3/37 • 48 weeks
|
|
Infections and infestations
COVID-19
|
25.0%
3/12 • 48 weeks
|
18.9%
7/37 • 48 weeks
|
|
Infections and infestations
URI
|
8.3%
1/12 • 48 weeks
|
2.7%
1/37 • 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • 48 weeks
|
5.4%
2/37 • 48 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • 48 weeks
|
2.7%
1/37 • 48 weeks
|
|
Infections and infestations
Oral Herpes Simplex
|
0.00%
0/12 • 48 weeks
|
2.7%
1/37 • 48 weeks
|
|
Infections and infestations
Genital Herpes Simplex
|
0.00%
0/12 • 48 weeks
|
5.4%
2/37 • 48 weeks
|
|
Infections and infestations
UTI
|
8.3%
1/12 • 48 weeks
|
5.4%
2/37 • 48 weeks
|
Additional Information
Dr. Emma Guttman
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-9728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place