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

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Information provided by:

Incyte Corporation

Last updated:

06/27/2022

Trial identifier:

NCT04530344

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Simplified Study Description Detailed Study Description

Study 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.

Study Recruitment Status:

Glossary term:

Recruitment status

Not yet recruiting: The study has not started recruiting participants. Recruiting: The study is currently recruiting participants. Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate. Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled. Suspended: The study has stopped early but may start again. Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated. Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred). Withdrawn: The study stopped early, before enrolling its first participant. Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.

Active, not recruiting

Age Eligible:

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+)

12 Years +

Sexes Eligible:

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.

All

Study 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.

Intervention Being Studied:

Drug: ruxolitinib

Drug: Vehicle

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.

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.

458 participants

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Incyte Corporation

Study 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

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Study Start Date (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.

September 24, 2020

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.

November 04, 2022

Placebo Arm:

Glossary term:

Placebo comparator arm

An arm type in which a group of participants receives a placebo during a clinical trial.

Yes

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Age Eligible: 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+)

Sexes Eligible: 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.

Study 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.

Intervention Being Studied:

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.

Sponsor: Glossary term: Sponsor The organization or person who initiates the study and who has authority and control over the study.