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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05593432
Recruitment Status : Recruiting
First Posted : October 25, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Lichen Planus Drug: Ruxolitinib cream Drug: Vehicle cream Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study will include a 16 week double-blind period followed by a 16 week open-label period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Actual Study Start Date : November 23, 2022
Estimated Primary Completion Date : October 10, 2023
Estimated Study Completion Date : February 19, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ruxolitinib cream
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 cream

Drug: Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Placebo Comparator: Vehicle Cream
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
Drug: Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.




Primary Outcome Measures :
  1. Proportion of Participants with Investigator's Global Assessment Treatment Success (IGA-TS) [ Time Frame: Week 16 ]
    Defined as an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.


Secondary Outcome Measures :
  1. Proportion of Participants achieving IGA-TS [ Time Frame: Up to Week 32 ]
    Defined as the percentage of participants achieving IGA-TS at each scheduled postbaseline visit.

  2. Proportion of Participants with ITCH4 response [ Time Frame: Up to Week 32 ]
    Defined as a ≥ 4-point improvement in the Itch Numeric Rating Scale (Itch NRS) score from baseline.

  3. Time to achieve ITCH4 [ Time Frame: Up to Week 32 ]
    Time to achieve >=4 point improvement in Itch NRS score

  4. Change from baseline in the Skin Pain Numeric Rating Scale (NRS) score [ Time Frame: Up to Week 32 ]
    Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours.

  5. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 36 weeks ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05593432


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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United States, Alabama
Cahaba Dermatology Recruiting
Birmingham, Alabama, United States, 35244
United States, Louisiana
Delricht Clinical Research - Clinedge - Ppds Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Ohio
Bexley Dermatology Recruiting
Bexley, Ohio, United States, 43209
United States, Oregon
Oregon Medical Research Center Not yet recruiting
Portland, Oregon, United States, 97223
United States, Texas
Arlington Center For Dermatology Recruiting
Arlington, Texas, United States, 76011-3800
Canada, Manitoba
Wiseman Dermatology Research Inc Not yet recruiting
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Ontario
Dr. S. K. Siddha Medicine Professional Corporation Not yet recruiting
Newmarket, Ontario, Canada, L3Y 5G8
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Haq Nawaz, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05593432    
Other Study ID Numbers: INCB 18424-216
First Posted: October 25, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Lichen Planus
Skin Diseases
18424
Ruxolitinib
topical cream
Additional relevant MeSH terms:
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Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases