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Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Information provided by:
Incyte Corporation
Last updated:
06/27/2022
Trial identifier:
NCT04530344
DisclaimerStudy Description
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.
Official Title
Glossary term:
Title
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.
Glossary term:
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
Type of Study
Glossary term:
Study Type
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study.
Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Glossary term:
Interventional
Enrollment (Actual)
Glossary term:
Enrollment
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.
Glossary term:
458
Phase
Glossary term:
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics.
There are five phases:
Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.
Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.
Glossary term:
Phase 3
Other Study ID Numbers
Glossary term:
Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.
Glossary term:
INCB 18424-308
Intervention / Treatment
Glossary term:
Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Glossary term:
Drug: ruxolitinib
Drug: Vehicle
Study Start (Actual)
Glossary term:
Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.
Glossary term:
Sep 24, 2020
Primary Completion (Anticipated)
Glossary term:
Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
Glossary term:
Nov 04, 2022
Study Completion (Anticipated)
Glossary term:
Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
Glossary term:
Nov 04, 2022
First Submitted Date
Glossary term:
First submitted
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
Glossary term:
Aug 25, 2020
First Submitted that Met QC Criteria
Glossary term:
First submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Glossary term:
Aug 25, 2020
First Posted (Actual)
Glossary term:
First posted
The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
Glossary term:
Aug 28, 2020
Last Update Submitted that Met MQ Criteria
Glossary term:
Last update submitted that met QC criteria
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Glossary term:
Jun 24, 2022
Last Update Posted (Actual)
Glossary term:
Last update posted
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.
Glossary term:
Jun 27, 2022
Contacts and Locations
Locations (44)
Northwestern University
Chicago, Illinois, United States, 60611
University of California San Francisco
San Francisco, California, United States, 94158
Advanced Pharma
Miami, Florida, United States, 33147
Dermatology Research Associates
Los Angeles, California, United States, 90045
Metro Boston Clinical Partners
Brighton, Massachusetts, United States, 02135
Wake Forest University
Winston-Salem, North Carolina, United States, 27104
Desert Sky Dermatology
Gilbert, Arizona, United States, 85295
San Marcus Research Clinic Inc.
Miami Lakes, Florida, United States, 33014
Olympian Clinical Research
Tampa, Florida, United States, 33614
Progressive Clinical Research
San Antonio, Texas, United States, 78213
Avita Clinical Research
Tampa, Florida, United States, 33613
Icahn School of Medicine At Mount Sinai
New York, New York, United States, 10029
Cahaba Dermatology
Hoover, Alabama, United States, 35244
Forcare Clinical Research Fcr Forward Clinical Trials, Inc
Tampa, Florida, United States, 33624
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Baton Rouge, Louisiana, United States, 70809
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States, 37130
Dermatology Specialists of Spokane
Spokane, Washington, United States, 99202
First Oc Dermatology
Fountain Valley, California, United States, 92708
Central Sooner Research
Norman, Oklahoma, United States, 73071
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States, 19462
Center For Dermatology Cosmetic and Laser Surgery
Fremont, California, United States, 94538
Marvel Clinical Research Llc
Huntington Beach, California, United States, 92647
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
Acrc Studies
San Diego, California, United States, 92119
Colorado Medical Research Center Inc
Denver, Colorado, United States, 80210
Harmony Medical Research Institute
Hialeah, Florida, United States, 33016
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States, 32174
Metabolic Research Institute Inc
West Palm Beach, Florida, United States, 33401
Randall Dermatology
West Lafayette, Indiana, United States, 47906
Tufts Medical Center
Boston, Massachusetts, United States, 02116
Great Lakes Research Group Inc
Bay City, Michigan, United States, 48706
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Minnesota Clinical Study Center
Minneapolis, Minnesota, United States, 55432
Jdr Dermatology Research
Las Vegas, Nevada, United States, 89148
Suny Downstate Medical Center
Brooklyn, New York, United States, 11203
Forest Hills Dermatology Group
Kew Gardens, New York, United States, 11415
The Dermatology Specialists Greenwich
New York, New York, United States, 10012
Derm Research Center of New York Inc
Stony Brook, New York, United States, 11790
Wake Research Associates Llc
Raleigh, North Carolina, United States, 27612
Kgl Skin Study Center
Broomall, Pennsylvania, United States, 19008
Palmetto Clinical Trial Services
Anderson, South Carolina, United States, 29621
Innovative Dermatology
Plano, Texas, United States, 75024
The Dermatology and Laser Center of San Antonio
San Antonio, Texas, United States, 78229
Clinical Research Partners Llc
Richmond, Virginia, United States, 23226
Contacts and Locations
Locations (44)
Northwestern University
Chicago, Illinois 60611
United States
University of California San Francisco
San Francisco, California 94158
United States
Advanced Pharma
Miami, Florida 33147
United States
Dermatology Research Associates
Los Angeles, California 90045
United States
Metro Boston Clinical Partners
Brighton, Massachusetts 02135
United States
Wake Forest University
Winston-Salem, North Carolina 27104
United States
Desert Sky Dermatology
Gilbert, Arizona 85295
United States
San Marcus Research Clinic Inc.
Miami Lakes, Florida 33014
United States
Olympian Clinical Research
Tampa, Florida 33614
United States
Progressive Clinical Research
San Antonio, Texas 78213
United States
Avita Clinical Research
Tampa, Florida 33613
United States
Icahn School of Medicine At Mount Sinai
New York, New York 10029
United States
Cahaba Dermatology
Hoover, Alabama 35244
United States
Forcare Clinical Research Fcr Forward Clinical Trials, Inc
Tampa, Florida 33624
United States
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Baton Rouge, Louisiana 70809
United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee 37130
United States
Dermatology Specialists of Spokane
Spokane, Washington 99202
United States
First Oc Dermatology
Fountain Valley, California 92708
United States
Central Sooner Research
Norman, Oklahoma 73071
United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania 19462
United States
Center For Dermatology Cosmetic and Laser Surgery
Fremont, California 94538
United States
Marvel Clinical Research Llc
Huntington Beach, California 92647
United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California 90036
United States
Acrc Studies
San Diego, California 92119
United States
Colorado Medical Research Center Inc
Denver, Colorado 80210
United States
Harmony Medical Research Institute
Hialeah, Florida 33016
United States
Leavitt Medical Associates of Florida
Ormond Beach, Florida 32174
United States
Metabolic Research Institute Inc
West Palm Beach, Florida 33401
United States
Randall Dermatology
West Lafayette, Indiana 47906
United States
Tufts Medical Center
Boston, Massachusetts 02116
United States
Great Lakes Research Group Inc
Bay City, Michigan 48706
United States
Henry Ford Medical Center
Detroit, Michigan 48202
United States
Minnesota Clinical Study Center
Minneapolis, Minnesota 55432
United States
Jdr Dermatology Research
Las Vegas, Nevada 89148
United States
Suny Downstate Medical Center
Brooklyn, New York 11203
United States
Forest Hills Dermatology Group
Kew Gardens, New York 11415
United States
The Dermatology Specialists Greenwich
New York, New York 10012
United States
Derm Research Center of New York Inc
Stony Brook, New York 11790
United States
Wake Research Associates Llc
Raleigh, North Carolina 27612
United States
Kgl Skin Study Center
Broomall, Pennsylvania 19008
United States
Palmetto Clinical Trial Services
Anderson, South Carolina 29621
United States
Innovative Dermatology
Plano, Texas 75024
United States
The Dermatology and Laser Center of San Antonio
San Antonio, Texas 78229
United States
Clinical Research Partners Llc
Richmond, Virginia 23226
United States
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.
Eligibility Criteria
Ages Eligible for Study:
Glossary term:
Age
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:
The age groups are:
Child (birth–17)
Adult (18–64)
Older adult (65+)
Glossary term:
12 Years +
Accepts Healthy Volunteers:
Glossary term:
Accepts Healthy Volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
Glossary term:
No
Sexes Eligible for Study:
Glossary term:
Sex
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
Glossary term:
All
Description:
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.
Study Plan
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
How is the study designed?
Design Details:
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel Assignment
Number of Arms:
3
Arms and Interventions:
Participant Group / Arm
Glossary term:
Arm
A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.
Glossary term:
Intervention / Treatment
Glossary term:
Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Glossary term:
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.
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.
Drug: ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
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.
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.
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.
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.
Drug: ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
What is the study measuring?
Primary Outcome Measures
Glossary term:
Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Glossary term:
Outcome Measure
Cohort A : Time to Relapse
Measure Description
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
Timeframe
Extension period through Week 108
Outcome Measure
Measure Description
Timeframe
Cohort A : Time to Relapse
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
Extension period through Week 108
Secondary Outcome Measures
Glossary term:
Secondary outcome measure
In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Glossary term:
Outcome Measure
Cohort A : Time to maintain ≥ F-VASI90 response
Measure Description
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
Timeframe
Extension period through Week 108
Outcome Measure
Proportion of participants achieving F-VASI50
Measure Description
≥ 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.
Timeframe
Extension period through Week 108
Outcome Measure
Proportion of participants achieving F-VASI75
Measure Description
≥ 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.
Timeframe
Extension period through Week 108
Outcome Measure
Proportion of participants achieving F-VASI90
Measure Description
≥ 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.
Timeframe
Extension period through Week 108
Outcome Measure
Proportion of participants achieving T-VASI50
Measure Description
≥ 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.
Timeframe
Extension period through Week 108
Outcome Measure
Proportion of participants achieving T-VASI75
Measure Description
≥ 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.
Timeframe
Extension period through Week 108
Outcome Measure
Proportion of participants achieving T-VASI90
Measure Description
≥ 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.
Timeframe
Extension period through Week 108
Outcome Measure
Actual Measurement of F-VASI
Measure Description
F-VASI actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Timeframe
Baseline through Week 108
Outcome Measure
Change in F-VASI
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in F-VASI
Timeframe
Baseline through Week 108
Outcome Measure
Percentage Change in F-VASI
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in F-VASI
Timeframe
Baseline through Week 108
Outcome Measure
Actual Measurement of T-VASI
Measure Description
T-VASI actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Timeframe
Baseline through Week 108
Outcome Measure
Change in T-VASI
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in T-VASI
Timeframe
Baseline through Week 108
Outcome Measure
Percentage Change in T-VASI
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in T-VASI
Timeframe
Baseline through Week 108
Outcome Measure
Actual Measurement of T-BSA
Measure Description
T-BSA actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Timeframe
Baseline through Week 108
Outcome Measure
Change in T-BSA
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in T-BSA
Timeframe
Baseline through Week 108
Outcome Measure
Percentage Change in T-BSA
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in T-BSA
Timeframe
Baseline through Week 108
Outcome Measure
Actual Measurement of F-BSA
Measure Description
F-BSA actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Timeframe
Baseline through Week 108
Outcome Measure
Change in F-BSA
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in F-BSA
Timeframe
Baseline through Week 108
Outcome Measure
Percentage Change in F-BSA
Measure Description
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in F-BSA
Timeframe
Baseline through Week 108
Outcome Measure
Proportion of participants achieving a VNS of 4 or 5
Measure Description
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.
Timeframe
Extension period through Week 108
Outcome Measure
Measure Description
Timeframe
Cohort A : Time to maintain ≥ F-VASI90 response
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
Extension period through Week 108
Proportion of participants achieving F-VASI50
≥ 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.
Extension period through Week 108
Proportion of participants achieving F-VASI75
≥ 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.
Extension period through Week 108
Proportion of participants achieving F-VASI90
≥ 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.
Extension period through Week 108
Proportion of participants achieving T-VASI50
≥ 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.
Extension period through Week 108
Proportion of participants achieving T-VASI75
≥ 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.
Extension period through Week 108
Proportion of participants achieving T-VASI90
≥ 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.
Extension period through Week 108
Actual Measurement of F-VASI
F-VASI actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Baseline through Week 108
Change in F-VASI
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in F-VASI
Baseline through Week 108
Percentage Change in F-VASI
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in F-VASI
Baseline through Week 108
Actual Measurement of T-VASI
T-VASI actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Baseline through Week 108
Change in T-VASI
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in T-VASI
Baseline through Week 108
Percentage Change in T-VASI
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in T-VASI
Baseline through Week 108
Actual Measurement of T-BSA
T-BSA actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Baseline through Week 108
Change in T-BSA
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in T-BSA
Baseline through Week 108
Percentage Change in T-BSA
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in T-BSA
Baseline through Week 108
Actual Measurement of F-BSA
F-BSA actual measurement from parent studies NCT04052425 or NCT04057573 will be utilized for baseline data
Baseline through Week 108
Change in F-BSA
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure change in F-BSA
Baseline through Week 108
Percentage Change in F-BSA
Baseline data from parent studies NCT04052425 or NCT04057573 will be utilized to measure percent change in F-BSA
Baseline through Week 108
Proportion of participants achieving a VNS of 4 or 5
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.
Extension period through Week 108
Sponsor and Collaborators
The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.
Sponsor:
Glossary term:
Sponsor
The organization or person who initiates the study and who has authority and control over the study.
Glossary term:
- Incyte Corporation
Investigators and Collaborators
Investigators and Collaborators
Investigators:
Glossary term:
Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
Glossary term:
Central Contacts:
Overall Officials:
- Kathleen Butler, MD
Collaborators:
Glossary term:
Collaborator
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Glossary term:
More Information
Publications
Publications of Study Results
General Publications
Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number
No publications available
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