Phase 2
N=64
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Cutaneous Lichen Planus
Bottom Line
View on ClinicalTrials.gov: NCT05593432 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 — 50.0; 21.9 percentage of participants — p=0.0129
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib cream (Drug); Vehicle cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 |
50.0; 21.9 | 0.0129 sig |
| SECONDARY Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period |
9.7; 6.5; 25.8; 13.3; 51.6; 12.9 | 0.0141 sig |
| SECONDARY Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period |
58.6; 25.0; 62.1; 33.3; 58.6; 44.0 | — |
| SECONDARY Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period |
21.4; 3.3; 44.8; 7.1; 53.8; 7.4 | 0.0027 sig |
| SECONDARY Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period |
72.7; 48.0; 73.9; 63.6; 79.2; 76.2 | — |
| SECONDARY Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period |
17.0; 97.0 | 0.0008 sig |
| SECONDARY Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period |
4.86; 4.51; -1.69; -0.55; -2.64; -0.69 | — |
| SECONDARY Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period |
4.86; 4.51; -3.65; -2.46; -3.81; -2.96 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period |
15; 9 | — |
| SECONDARY Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period |
0; 0 | — |
| SECONDARY Number of Participants With Any TEAE During the Open-label Extension Period |
8; 11 | — |
| SECONDARY Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period |
0; 1 | — |
Summary
The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of LP with predominant cutaneous involvement.
- IGA score of 3 or 4 at screening and baseline.
- Baseline LP-related Itch NRS score ≥ 4.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
- Concurrent conditions and history of other diseases:
- Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.
- Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
- Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.
- Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week before baseline.
- Laboratory values outside of the protocol-defined criteria.
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
- Other exclusive criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05593432). 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.