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A study testing TRIV-509 compared to placebo in adults with moderate to severe atopic dermatitis

Fast replyInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with atopic dermatitis, which is a long-lasting skin condition that causes red, itchy, and inflamed skin. The condition being studied is classified as moderate to severe, meaning it affects a larger area of the body or causes more significant symptoms. The study will test a medication called TRIV-509, which is a type of treatment designed to target specific proteins in the body that are believed to play a role in causing the skin inflammation and itching associated with atopic dermatitis. Some participants will receive TRIV-509 while others will receive placebo. The medication will be given as an injection under the skin, also known as subcutaneous injection.

The purpose of this study is to find out how well TRIV-509 works in improving the symptoms of moderate to severe atopic dermatitis in adults, and also to learn about its safety and how the body processes the medication. The study will look at whether the treatment can reduce the severity of the skin condition and improve symptoms such as itching. During the study, participants will receive the medication or placebo through injections under the skin for a period of 12 weeks. The total study duration will be longer as participants will be followed up to see how they respond to the treatment and to monitor for any side effects. Throughout the study, participants will be asked to continue using a moisturizer on their skin at a steady amount.

The study will measure various outcomes to understand if the treatment is working, including the percentage of people whose atopic dermatitis improves after 16 weeks. The study will also track any unwanted effects that might occur, changes in vital signs such as blood pressure and heart rate, results from heart rhythm tests, and laboratory test results from blood samples. Additionally, the study will measure how the medication moves through the body and whether the body develops any immune response against the medication. Participants will need to avoid excessive sun exposure and tanning beds during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline Visit and First Treatment
At the first visit, a urine pregnancy test will be performed before receiving the first dose of the study medication.
The first dose of either TRIV-509 or placebo will be administered as an injection under the skin.
A stable dose of topical moisturizer should be applied throughout the study as instructed.
Natural and artificial sunlight exposure should be minimized during the study. Tanning booths, sun lamps, or other ultraviolet light sources should not be used.
Step 2
Treatment Period
The study medication (TRIV-509 or placebo) will be administered by injection under the skin for a period of 12 weeks.
Multiple doses will be given during this period according to the study schedule.
Current medications for conditions other than atopic dermatitis should be continued at the same dose without starting new medications, changing doses, or stopping them during the treatment period.
If a hormonal contraceptive is used, it should be continued at the same dose throughout the treatment period.
Step 3
Assessment at Week 16
At week 16, an assessment will be conducted to evaluate improvement in atopic dermatitis symptoms.
Various measurements will be taken to assess the condition of the skin and overall response to treatment.
Step 4
Safety Monitoring Throughout the Study
Vital signs (such as blood pressure, heart rate, and temperature) will be measured at scheduled visits.
ECG (a test that measures the electrical activity of the heart) will be performed at designated time points.
Blood tests will be conducted to monitor safety parameters.
Any adverse events (unwanted or harmful effects) will be recorded and evaluated throughout the study.
Blood samples will be collected to measure the levels of the study medication in the body and to check for antibodies against TRIV-509.
Step 5
Contraception Requirements During Study
If of childbearing potential, a highly effective contraceptive method (with less than 1% failure rate per year) must be used until the end of the study or for at least 24 weeks after the last dose, whichever is later.
Male participants must use an additional highly effective contraceptive method when having sexual intercourse with a partner of childbearing potential until the end of the study or for at least 24 weeks after the last dose, whichever is later.
Male participants should refrain from donating sperm or fathering a child from the first dose until at least 24 weeks after the last dose.
Female participants should not donate eggs until the end of the study or for at least 24 weeks after the last dose, whichever is later.
Step 6
End of Study
The study will conclude after all scheduled assessments have been completed.
Contraceptive requirements and restrictions on sperm or egg donation will continue for at least 24 weeks after the last dose of study medication.

Who can join the trial?

15 criteria

You must be between 18 and 75 years old at the time you sign the consent form
You must have chronic atopic dermatitis, which means long-lasting skin inflammation that causes itching and redness
Your atopic dermatitis must not have had any major worsening episodes for at least 28 days before screening
You must have moderate to severe atopic dermatitis that is currently active and causing symptoms
You must meet specific requirements for itching severity score at the beginning of the study
You must have needed systemic therapy, which means medications taken by mouth or injection to control your atopic dermatitis, OR you cannot use creams or ointments applied to the skin, OR creams and ointments have not worked well enough for you for at least 28 days
You must weigh at least 40 kilograms
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and agree to use highly effective birth control methods during the study and for at least 24 weeks after the last dose
If you are a woman who can become pregnant, you must agree not to donate eggs until at least 24 weeks after the last dose
If you are a man who can father children, you must agree not to donate sperm or father a child from the first dose until at least 24 weeks after the last dose
If you are a man who can father children, you must agree to use highly effective birth control methods when having intercourse with a partner who can become pregnant during the study and for at least 24 weeks after the last dose
You must sign the informed consent form, showing you understand and agree to follow the study requirements
You must be willing to apply a moisturizer regularly throughout the study without changing the amount you use
If you are taking medications for conditions other than atopic dermatitis, you must be on a stable dose, meaning no new medications or dose changes for at least 7 days before starting the study
You must not have had excessive sun exposure or used tanning booths within 28 days before starting, and you must agree to limit sun exposure and avoid tanning booths and ultraviolet light sources during the study

Who cannot join the trial?

3 criteria

The study information does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in this study for atopic dermatitis (a skin condition that causes red, itchy, and inflamed skin), you should discuss with the study team to learn about any restrictions that may apply
General exclusion reasons in clinical trials may include having certain other medical conditions, taking specific medications, being pregnant or breastfeeding, or having recently participated in other research studies

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Responsive
Sosnowiec, Poland
EMC Instytut Medyczny S.A.
Verified
Poznan, Poland
Medical Center Medconsult Pleven OOD
Verified
Pleven, Bulgaria

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Investigated drugs

TRIV-509
is an investigational medication being tested in this clinical trial. It is given as an injection under the skin (subcutaneous injection) to treat moderate to severe atopic dermatitis, which is a skin condition that causes itchy and inflamed skin. The study is looking at whether this medication can help improve the symptoms of atopic dermatitis when given over a period of 12 weeks.
Placebo
is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against TRIV-509 to help determine if the actual medication is effective. Some participants will receive the placebo injections instead of the real medication.

HUMAN IGG1 BISPECIFIC MONOCLONAL ANTIBODY AGAINST KALLIKREIN-5 AND KALLIKREIN-7

What is already known about the treatment

TRIV-509 – TRIV-509 is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is administered through subcutaneous injection, which means it is injected under the skin, and is being evaluated for the treatment of moderate to severe atopic dermatitis, a chronic skin condition that causes red, itchy, and inflamed skin. The exact way TRIV-509 works at the molecular level has not been fully disclosed in available trial information, but it is designed to target specific mechanisms involved in the inflammatory process of atopic dermatitis. This medication is being tested to determine if it can effectively reduce symptoms and improve the quality of life for adult patients suffering from this uncomfortable skin condition.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition that causes the skin to become red, itchy, and dry. The disease typically appears in childhood but can occur at any age, often running in families with a history of allergies or asthma. The skin becomes very sensitive and reactive to various triggers such as allergens, irritants, stress, or changes in temperature. During flare-ups, the affected areas may develop patches of rough, scaly skin that can crack and sometimes ooze fluid. The itching can be intense and persistent, leading to scratching that further damages the skin and creates a cycle of irritation. The condition tends to follow a pattern of flare-ups and periods of improvement, with symptoms varying in severity over time.