Phase 2
N=12
Topical Ruxolitinib Lichen Planus
Lichen Planus
Bottom Line
View on ClinicalTrials.gov: NCT03697460 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) — 11.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INCB018424 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aaron R. Mangold
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) |
11.0 | — |
| PRIMARY Change in Total Body Lesion Count |
50 | — |
| SECONDARY Change in Pruritus Numerical Rating Scale |
4.4 | — |
| SECONDARY Change in Overall Quality of Life Skindex-16 Score |
36.3 | — |
| SECONDARY Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score |
12 | — |
| SECONDARY Body Surface Area (BSA) Affected by Cutaneous Lichen Planus |
6.1; 0.9 | — |
Summary
To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.
Eligibility Criteria
Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator.
Subjects must give written, signed, and dated informed consent before any study related activity is performed.
When appropriate, a legal representative will sign the informed consent according to local laws and regulation
Both men and women must be at least 18 years of age at the time of screening
Subjects must have clinical and histological features of LP
LP must involve between 2 and 20% of the BSA
Subjects must have a minimum of 10 lesions of LP
Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP
Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid
Data sourced from ClinicalTrials.gov (NCT03697460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.