Have you been diagnosed with vitiligo?
The REGINA Vitiligo Clinical Trial is evaluating an investigational medication in people with vitiligo to see whether it is safe and effective compared to a placebo.
What Is the REGINA Study?
The REGINA Study is testing an investigational study drug to see if it may safely and effectively reduce symptoms of vitiligo in adults compared to placebo. If you qualify and decide to take part, you will be in this research study for up to 14 months, including 16 study visits and 4 phone calls. There will be a treatment period (during which you will be assigned by chance to receive either the investigational study drug or a placebo) followed by an extension period (during which everyone will receive the investigational study drug). The investigational study drug or the a placebo will be given as an injection (shot) under the skin every 2 weeks.
Researchers want to learn:
- About the safety of the investigational study drug and any side effects
- If the investigational study drug works compared to a placebo
CLINICALTRIALS.GOV IDENTIFIER
NCT06113328
EU CT Number
2023-503502-37-00
When you talk with your doctor or clinical trial team member, please have the trial identifier number available.
How to Qualify
You may be able to take part in this research study if you:
- Are aged 18 to 75 years
- Have been diagnosed with vitiligo and have had symptoms for at least 6 months
There are more requirements to participate in this research study. The study doctor will talk with you about all the requirements.
If you qualify and decide to participate:
- You will receive the investigational study drug and all study-related medical tests at no cost
- Your vitiligo and overall health will be closely monitored by a study doctor
- You may be eligible to be reimbursed for study-related travel costs
- You may help researchers learn more about vitiligo and the investigational study drug
Participation in the research study is voluntary, and you are free to leave the research study at any time. Your privacy will be maintained throughout the research study.
Will I Receive the Investigational Study Drug?
During the treatment period, study participants will be randomly placed (assigned by chance) into 1 of 3 groups. You will have an equal chance of being placed in any of these groups.
- 2 groups will get the investigational study drug
- 1 group will get a placebo. A placebo looks like the study drug but has no active ingredients
During the extension period, all participants will receive the investigational study drug.
What Will Happen During the Research Study?
The research study has 4 parts: screening, treatment, extension, and follow-up.
Screening
(up to 4 weeks)
You will have medical tests to see if you qualify for the research study. You will visit the study site once.
Study Treatment Period
(24 weeks)
You will receive the investigational study drug or a placebo. There will be 9 visits and 2 phone calls.
Extension
(28 weeks)
Everyone will receive the investigational study drug. There will be 6 visits and 1 phone call.
Follow-up
(about 4 weeks after the last injection of investigational study drug)
You will receive a follow-up phone call from the study team.
Study Tests
During the research study, you will undergo different tests to evaluate your vitiligo and overall health. You will not have every test on every visit.
Tests include, but are not limited to:
- Questionnaires about your health and quality of life
- Photography of your face and body
- Physical exams
- Electrocardiograms (ECGs, which check your heart function)
- Chest X-rays
- Blood and urine tests
What Is Vitiligo?
Vitiligo is a disorder in which areas of the skin lose pigment or color. The skin cells that make pigment are called melanocytes. In vitiligo, they are attacked and destroyed by the immune system, leaving white patches.1 There are 2 types of vitiligo: segmental (in which patches occur on only 1 side or segment of the body) and non-segmental (which is more common; patches occur on both sides of the body, for example, on both hands).1
In addition to the skin, vitiligo can affect the mucous membranes (for example, inside your nose or mouth). It can also impact your hair (including eyebrows, beards, etc), causing white patches.1
People of any race or skin color can get vitiligo. Approximately half of those who develop vitiligo get it before age 20.2 There is no cure, but treatments may help stop it from getting worse and may help make skin tone appear more even.1
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest study site. Talk with a study site member for more information.
Frequently Asked Questions
About the REGINA Study
The REGINA Study is being conducted to evaluate whether an investigational study drug may help safely and effectively reduce the symptoms of vitiligo in adults.
There are requirements that must be met in order to take part in this study. The trial doctor or staff will discuss them with you. Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo looks like the investigational study drug but does not contain any active medication. In the first part of this research study, you will be randomly placed (assigned by chance) into 1 of 3 groups. You will have a:
- 2 in 3 chance (67%) of receiving the investigational study drug
- 1 in 3 chance (33%) of receiving the placebo
In the extension part of this research study, everyone will get the investigational study drug.
Privacy, Stopping Participation, Costs, and Permission
The study team respects and protects your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Yes, your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final visit and return any unused study drugs.
No, you will receive the study drugs at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
About Research Studies
A research study, also known as a clinical trial, tries to answer questions about how medications work in the people who take them. Researchers run research studies to test whether an investigational study drug is safe and effective. These research studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the US, this group is called an IRB or Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine whether you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational study drug is a drug that hasn’t yet been approved for use in the general public. In order to be approved, the investigational study drug must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.
The investigational study drug in the REGINA Study is being tested in people with vitiligo to see if it may safely and effectively reduce symptoms of vitiligo.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions visit: https://www.msdclinicaltrials.com/faq/
What Can You Do Next?
If you think this research study might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Discuss with your doctor or care team
Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.
CLINICALTRIALS.GOV IDENTIFIER
NCT06113328
EU CT Number
2023-503502-37-00
When you talk with your doctor or clinical trial team member, please have the trial identifier number available.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational study drug that is being studied
- The possible risks and benefits for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
References:
- Vitiligo. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Accessed October 9, 2023. https://www.niams.nih.gov/health-topics/vitiligo
- Vitiligo: causes. American Academy of Dermatology Association. Updated June 29, 2022. Accessed October 9, 2023. https://www.aad.org/public/diseases/a-z/vitiligo-causes