Garnet

Study Overview

The GARNET study is researching a study drug called tildrakizumab for adults with genital psoriasis. Tildrakizumab is currently approved in several countries for the treatment of moderate to severe plaque psoriasis in adults. Doctors now want to learn about its effectiveness and safety when used for genital psoriasis. This study has been approved by the National Center for Public Health and Pharmacy and has been given a favorable opinion by the Medical Research Council Ethics Committee of Clinical Pharmacology.

Who Can Participate in the Garnet Study?

To be eligible for this study, individuals must:

  • Be at least 18 years of age

  • Be willing to sign a consent document and attend study visits

  • Be diagnosed with moderate or severe genital psoriasis

  • Have some psoriasis lesions in other parts of the body as well

This is not a complete list of study requirements. The study doctor will review the full requirements with you.

What Can I Expect If I Decide To Participate?

Those who are eligible to participate in the GARNET study will be assigned to 1 of 2 study treatment groups. In one group, study participants will receive the study drug, tildrakizumab, throughout the study treatment period. In the other group, participants will receive a placebo for the first 4 months and then will receive tildrakizumab. Eligible study participants will attend up to 16 visits at the study site; this includes the initial screening visit and the follow-up visit.

1

Screening Period (up to 4 weeks)

  • Before any study-related tests and procedures are performed, you will be asked to read and sign a consent document. The study doctor will then ask you some questions, and you will undergo an evaluation to determine if you qualify to take part in this study.

    • 2

    Study Treatment Period (52 Weeks)

  • • Review of study eligibility criteria • Questions about your medical history and about medications you have taken in the past • Questions about medications you have taken recently or are currently taking • Review of how you are feeling • Complete physical examination • Measurement of vital signs (blood pressure, breathing rate, heart rate, and temperature) • Blood and urine sample collection • Pregnancy test (females of childbearing potential only) • ECG • Psoriasis assessment to check how much of your body is affected by psoriasis • Questionnaires about symptoms, quality of life, and mental health • Assignment into a study treatment group (you will not know which group you’ve been assigned to) • Receive a dose of study drug by injection under the skin

    • 3

    Follow-Up Period (20 weeks)

  • • Questions about medications you have taken recently or are currently taking • Review of how you are feeling • Complete physical examination • Measurement of vital signs (blood pressure, breathing rate, heart rate, and temperature) • Blood and urine sample collection • Pregnancy test (females of childbearing potential only) • Psoriasis assessment to check how much of your body is affected by psoriasis • Questionnaires about symptoms, quality of life, and mental health

    • Why is the GARNET study important?

    Psoriasis is a long-lasting skin condition that can be uncomfortable and painful. People with genital psoriasis often experience intense itching and burning that can affect their daily activities and quality of life. Researchers want to learn if tildrakizumab can make a difference for people with genital psoriasis. Clinical studies like this one can help doctors as they try to find new and better ways to treat diseases. Being part of discovering new health information may help others in the future.

    Frequently Asked Questions

    What is a clinical study?

    A clinical study is a type of research or investigation to learn more about a certain disease or condition. In this case, doctors want to learn more about genital psoriasis. Volunteers who participate in this research study can help doctors add to their medical knowledge of this condition.

    What risks are involved for study participants?

    There are possible risks involved with any clinical study. The research staff will review the risks with all study participants and will closely monitor their health throughout the study.

    Why should I take part in this study?

    Participation in a clinical study is voluntary. Clinical studies are important for medical advances. By participating in the study, you: • Will be closely monitored through regular visits with your study doctor to check your condition. • May be part of discovering new health information that could help others in the future.

    What are the costs to take part in this study?

    There is no cost to participate in this study. Participants will receive all study-related procedures and the study drug, tildrakizumab, at no cost.

    How long will this study last?

    The study will last approximately 1 year and 6 months (76 weeks). This includes a 4-week screening period to see if you are eligible to be in the study, and a 20-week follow-up period that takes place once active study treatment ends.

    What is a placebo?

    A placebo is a substance that looks just like the study drug but contains no active study drug

    What study procedures and assessments can I expect during my participation in the GARNET study?

    Study eligibility criteria : A check to see if you meet all of the criteria for participation in this study. Demographics : Includes general information questions, including your name, date of birth, and race. Health and medication history : Includes questions about full medical history, psoriasis history, and prior and current medications. Physical examination : A general health examination of the body, including an assessment of the severity of your psoriasis. Targeted physical examination : A brief examination of the body based on how you are feeling and any symptoms you might be having. Vital signs : A check of your blood pressure, breathing rate, heart rate (pulse), and body temperature. Blood sample collection : Blood samples will be taken for tests such as hematology (red and white blood cell counts; the relation of solid and liquid parts of blood), coagulation (how fast blood clots are formed), lipids (another word for fats), serology (to test how blood reacts to foreign substances), clinical chemistry (for example, the sugar and salt content of your blood), pharmacokinetics (to see how the body handles the study drug), and anti-drug antibodies (to see whether your body produces an immune response against the study drug). Blood will also be tested for infectious viral diseases (human immunodeficiency virus [HIV], hepatitis B, hepatitis C, and tuberculosis). Urine sample collection : Following the blood tests, you will be asked to give a urine sample to measure different chemicals to evaluate general health. Chest x-ray : A type of screening test that takes a digital image of the structures inside the body. Pregnancy test : Female participants of childbearing potential must perform a blood pregnancy test before starting the study. Urine pregnancy tests will also be performed throughout the study to confirm that you are not pregnant. Electrocardiogram (ECG) : This test is performed by placing electrodes with sticky patches on your chest, arms, and legs and connecting these electrodes to a machine that will provide information about the electrical activity of your heart. Psoriasis questionnaires : These questions will be asked at the time of your clinic visits to monitor your results and experience in the study. Quality of life questionnaires : These questions will ask about how your symptoms affect your daily activities and your life. Mental health questionnaires : The Columbia Suicide Severity Rating Scale (C-SSRS) will be done at each visit to monitor any changes in your thoughts or behavior. If this assessment shows you are at risk, you may be referred to a mental health professional. Study drug administration : Tildrakizumab and/or placebo will be administered by subcutaneous (under the skin) injection.