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Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530344
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: ruxolitinib Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : November 4, 2022
Estimated Study Completion Date : November 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Cohort A : ruxolitinib cream
Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream.
Drug: ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
Other Name: INCB018424 Cream

Placebo Comparator: Cohort A : Vehicle
Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream.
Drug: Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.

Experimental: Cohort B : roxolitinib cream
Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream.
Drug: ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
Other Name: INCB018424 Cream




Primary Outcome Measures :
  1. Cohort A : Time to Relapse [ Time Frame: Extension period through Week 108 ]
    Defined as the time when a participant does not achieve F-VASI75. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study


Secondary Outcome Measures :
  1. Cohort A : Time to maintain ≥ F-VASI90 response [ Time Frame: Extension period through Week 108 ]
    Defined as time to maintain ≥ 90% improvement in F-VASI Score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study

  2. Proportion of participants achieving F-VASI50 [ Time Frame: Extension period through Week 108 ]
    ≥ 50% improvement from baseline in F-VASI score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.

  3. Proportion of participants achieving F-VASI75 [ Time Frame: Extension period through Week 108 ]
    ≥ 75% improvement from baseline in F-VASI score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.

  4. Proportion of participants achieving F-VASI90 [ Time Frame: Extension period through Week 108 ]
    ≥ 90% improvement from baseline in F-VASI score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.

  5. Proportion of participants achieving T-VASI50 [ Time Frame: Extension period through Week 108 ]
    ≥ 50% improvement from baseline in T-VASI score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.

  6. Proportion of participants achieving T-VASI75 [ Time Frame: Extension period through Week 108 ]
    ≥ 75% improvement from baseline in T-VASI score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.

  7. Proportion of participants achieving T-VASI90 [ Time Frame: Extension period through Week 108 ]
    ≥ 90% improvement from baseline in T-VASI score. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.

  8. Actual Measurement of F-VASI [ Time Frame: Baseline through Week 108 ]
    F-VASI actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data

  9. Change in F-VASI [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in F-VASI

  10. Percentage Change in F-VASI [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in F-VASI

  11. Actual Measurement of T-VASI [ Time Frame: Baseline through Week 108 ]
    T-VASI actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data

  12. Change in T-VASI [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in T-VASI

  13. Percentage Change in T-VASI [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in T-VASI

  14. Actual Measurement of T-BSA [ Time Frame: Baseline through Week 108 ]
    T-BSA actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data

  15. Change in T-BSA [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in T-BSA

  16. Percentage Change in T-BSA [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in T-BSA

  17. Actual Measurement of F-BSA [ Time Frame: Baseline through Week 108 ]
    F-BSA actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data

  18. Change in F-BSA [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in F-BSA

  19. Percentage Change in F-BSA [ Time Frame: Baseline through Week 108 ]
    Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in F-BSA

  20. Proportion of participants achieving a VNS of 4 or 5 [ Time Frame: Extension period through Week 108 ]
    The VNS is a patient-reported measure of vitiligo treatment success, which has a 5-point scale, with 1 being more noticeable and 5 being no longer noticeable. Participants who completed parent studies NCT04052425 and NCT04057573 will begin extension period at week 52 in this study.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
  • Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
  • Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
  • Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
  • Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.

Exclusion Criteria:

  • Has been permanently discontinued from study treatment in the parent study for any reason.
  • Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
  • Pregnant or breastfeeding woman.
  • Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.

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): NCT04530344


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Chair: Kathleen Butler, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04530344    
Other Study ID Numbers: INCB 18424-308
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 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:
INCB018424
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases