Trial Outcomes & Findings for Topical Ruxolitinib Lichen Planus (NCT NCT03697460)

Last Updated: 2021-08-04

Results Overview

mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

week 0, week 4

Results posted on

2021-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	INCB018424 Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	INCB018424 Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Topical Ruxolitinib Lichen Planus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Duration of Disease	1.25 years STANDARD_DEVIATION 1.13 • n=5 Participants
Number of Prior Treatments	2.2 prior treatments STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: week 0, week 4

Outcome measures

Outcome measures
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)	11.0 score on a scale Standard Deviation 6.2

PRIMARY outcome

Timeframe: week 0, week 4

The number of total body lesions.

Outcome measures

Outcome measures
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Change in Total Body Lesion Count	50 lesions Interval 25.0 to 723.0

SECONDARY outcome

Timeframe: week 0, week 4

Pruritus Numerical Rating Scale as measured by they question "How severe has your itching been over the last 24 hours?" Ranging from 0 = none, to 10 = severe. The higher the score the more severe.

Outcome measures

Outcome measures
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Change in Pruritus Numerical Rating Scale	4.4 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: week 0, week 4

Skindex-16 score as measured by 16 questions, 3 subscales: Symptoms, Emotional, Functional. Score ranges for each question (0-6). Total score ranging from 0-96 with higher score indicating worse quality of life

Outcome measures

Outcome measures
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Change in Overall Quality of Life Skindex-16 Score	36.3 score on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: week 0, week 4

PGA score as measured by Grade 0 (clear: no evidence of disease (100% improvement)) to Grade 6 (Worse, disease is worse than at baseline evaluation by (≥25%) or more). Higher score equals worse disease

Outcome measures

Outcome measures
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score	12 participants

SECONDARY outcome

Timeframe: week 0, week 4

BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body.

Outcome measures

Outcome measures
Measure	INCB018424 n=12 Participants Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus Week 0	6.1 mean percentage of body surface area Standard Deviation 7.9
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus Week 4	0.9 mean percentage of body surface area Standard Deviation 1.9

Adverse Events

INCB018424

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	INCB018424 n=12 participants at risk Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Nervous system disorders Abnormal Taste	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Blood and lymphatic system disorders Blood Clot	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
General disorders Cold	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Nervous system disorders Dizziness	16.7% 2/12 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
General disorders Fever	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Renal and urinary disorders Incontinence	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Nervous system disorders Light headedness	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Psychiatric disorders Sleep Disturbance	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Musculoskeletal and connective tissue disorders Pressure on right arm	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Infections and infestations Sinus Infection	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Infections and infestations Vaginal Infection	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Infections and infestations Yeast Infection	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 weeks.

Additional Information

Aaron R. Mangold, M.D.

Mayo Clinic

Phone: 480-301-6479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place