A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Incyte

Status and phase: Completed; Phase 2

Conditions: Cutaneous Lichen Planus

Treatments: Drug: Vehicle cream; Drug: Ruxolitinib cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05593432

INCB 18424-216

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. 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.
  2. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
  3. 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.
  4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
  5. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
  6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 2 patient groups, including a placebo group

Ruxolitinib cream

Experimental group

Description:

Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

Treatment:

Drug: Ruxolitinib cream

Drug: Vehicle cream

Vehicle Cream

Placebo Comparator group

Description:

Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

Treatment:

Drug: Vehicle cream