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Study of K1-70 compared to placebo for patients with active thyroid eye disease from Graves' disease

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This study is looking at Graves' disease with active thyroid eye disease. Graves' disease is a condition where the immune system affects the thyroid gland, which can lead to problems with the eyes. Thyroid eye disease causes inflammation and swelling of the muscles and tissues around the eyes, which can make the eyes bulge forward, cause double vision, and lead to discomfort or changes in appearance. The study will test a medication called K1-70, which is a type of antibody designed to target a specific receptor related to the thyroid. Some participants will receive K1-70 while others will receive placebo. The medication will be given as an intravenous infusion, which means it will be delivered directly into a vein.

The purpose of the study is to compare how well K1-70 works compared to placebo in reducing the bulging of the eyes in people with active thyroid eye disease. The main focus is to see if K1-70 can help decrease how much the eyes protrude forward by at least a certain amount after 24 weeks of treatment. The study will also look at other aspects of the disease, such as changes in eye muscle inflammation seen on MRI scans, improvements in quality of life, changes in disease activity scores, improvements in double vision, and changes in the volume of tissue behind the eye. Additionally, the study will monitor safety by checking for any side effects, measuring vital signs, performing heart tests with an ECG, conducting laboratory tests, and examining the eyes and overall health of participants.

Participants will receive K1-70 or placebo once every 6 weeks for a total of 24 weeks. The study will measure various outcomes throughout the treatment period and will continue to follow participants after the treatment is completed. The medication will be given at a dose of up to 100 milligrams per infusion, with a maximum total dose of 800 milligrams over the entire treatment period of 48 weeks. The study will also measure the levels of the medication in the blood over time and check for any immune responses to the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period with study medication
This period lasts for 24 weeks. During this time, you will receive either the study medication called K1-70 or a placebo (an inactive substance that looks like the real medication but contains no active ingredient).
The medication will be given as an intravenous infusion (a slow injection directly into your vein) once every 6 weeks. This means you will receive a total of 5 infusions during the treatment period.
The study is double-masked, which means neither you nor your doctor will know whether you are receiving K1-70 or placebo during the treatment period.
Step 2
Regular monitoring visits
Throughout the study, you will attend scheduled visits at the study site. During these visits, various assessments will be performed to monitor your condition and safety.
At each visit, measurements of your eye protrusion (how far your eye bulges forward, also called exophthalmos) will be taken. The study aims to see if there is at least a 2 millimeter decrease in eye protrusion in the affected eye.
Your doctor will assess the Clinical Activity Score (a measurement system that evaluates signs of active inflammation in your eyes, such as pain, redness, and swelling).
You will be asked about your double vision (seeing two images of a single object, also called diplopia), and any changes will be recorded using a specific grading scale.
Step 3
Imaging examinations
Magnetic resonance imaging (MRI) scans may be performed during the study. This is a type of scan that uses magnetic fields to create detailed images of the structures inside your eye socket.
The MRI will measure changes in the eye muscles and the tissue volume behind your eyeball (called retrobulbar volume). These measurements help assess whether the inflammation and swelling are improving.
Step 4
Quality of life assessments
You will complete questionnaires to assess your quality of life related to your eye condition. This is measured using a tool called the GO-QOL score, which evaluates how your eye disease affects your daily activities and emotional well-being.
These assessments will be repeated at different time points during the study to track any changes.
Step 5
Safety monitoring
Throughout the study, your safety will be closely monitored. This includes recording any adverse events (unwanted or unexpected medical occurrences that may or may not be related to the study medication).
Your vital signs (such as blood pressure, heart rate, and temperature) will be measured regularly.
You will have blood tests performed to check your overall health, liver and kidney function, and to measure levels of thyroid hormones (substances produced by your thyroid gland) and thyroid-stimulating hormone (TSH, a hormone that controls your thyroid gland).
Blood samples will also be taken to measure the levels of the study medication in your blood and to check for anti-drug antibodies (proteins your immune system might produce in response to the medication).
An electrocardiogram (ECG, a test that records the electrical activity of your heart) will be performed at certain visits.
A physical examination and eye examination will be conducted to assess your overall health and eye condition.
Step 6
Thyroid function management
Your thyroid function should be controlled and stable before starting the study. Your thyroid hormone levels should be normal, or you may have mild hypothyroidism (underactive thyroid) or hyperthyroidism (overactive thyroid).
Efforts will be made to keep your thyroid function stable throughout the entire study period. Your doctor will monitor your thyroid hormone levels regularly to ensure they remain within acceptable ranges.
Step 7
Final assessment at week 24
At week 24, the primary assessment will be performed to determine the exophthalmos improvement rate. This measures whether your eye protrusion has decreased by at least 2 millimeters in the affected eye without worsening in the other eye.
All other measurements and assessments described in previous steps will also be completed at this final visit of the treatment period.

Who can join the trial?

9 criteria

You must be between 18 and 75 years old at the time you sign the consent form
You must sign and date a consent form showing you understand the study and agree to take part
You must have Graves' disease, which is a condition where your immune system affects your thyroid gland, and you must have active thyroid eye disease, which means your eyes are currently affected and inflamed
Your study eye must show either swelling of the eye muscles seen on an MRI scan, which is a special imaging test, or have a Clinical Activity Score of at least 3, which is a measure of how active and inflamed your eye disease is
Your eye must bulge forward at least 18 millimeters, or if less than 18 millimeters, your study eye must bulge at least 3 millimeters more than your other eye
You must have symptoms such as eyelid retraction, which means your eyelid pulls back more than normal, swelling of soft tissues around the eye, or diplopia, which means seeing double
You must have experienced symptoms of active thyroid eye disease within the 12 months before joining the study
Your thyroid function must be controlled and normal at the time of joining, or you may have mild hypothyroidism, which means your thyroid is slightly underactive, or mild hyperthyroidism, which means your thyroid is slightly overactive
If you are a woman who can become pregnant or a man with a female partner who can become pregnant, you must agree to use acceptable birth control methods during the study

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified in the available study information

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Verified sites

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

Verified
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Verified
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, Italy
Verified
Clinica De Oftalmologia De Cordoba S.L.
Cordoba, Spain

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Investigated drugs

K1-70
is an experimental medication being tested to treat active thyroid eye disease in people with Graves' disease. This medicine is given as an injection once every 6 weeks for 24 weeks. The goal is to see if it can help reduce eye bulging, which is a common problem in patients with this condition.
Placebo
is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against K1-70 to help researchers understand if the experimental medication actually works.

HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR

What is already known about the treatment

K1-70 – K1-70 is an investigational medication currently being studied in clinical trials for the treatment of active thyroid eye disease in patients with Graves' disease. It is administered as an injection given once every 6 weeks over a 24-week period. The medication is being evaluated to determine if it can reduce eye bulging (exophthalmos), which is a common and distressing symptom where the eyes protrude forward due to inflammation and swelling of tissues behind the eye. While the exact way K1-70 works at the cellular level has not been specified in available trial information, it is being tested as a potential treatment option for this autoimmune condition that affects the eyes.

Investigated diseases

Graves' Disease
Graves' disease is an autoimmune disorder that affects the thyroid gland, causing it to produce too much thyroid hormone. The immune system creates antibodies that mistakenly attack the thyroid gland, leading to its overactivity. This condition results in the thyroid gland becoming enlarged and releasing excessive amounts of hormones into the bloodstream. Common symptoms include weight loss, rapid heartbeat, increased sweating, nervousness, and trembling hands. The disease can also affect the eyes, leading to a condition called thyroid eye disease. Graves' disease typically develops gradually and can occur at any age, though it is most common in adults between 30 and 50 years old.
Thyroid Eye Disease
Thyroid eye disease is an inflammatory condition that affects the muscles and tissues around the eyes. It occurs when the immune system attacks the tissue behind the eyeballs, causing swelling and inflammation. The inflammation leads to the eyeballs being pushed forward, resulting in a bulging appearance known as exophthalmos. Patients may experience eye pain, redness, excessive tearing, light sensitivity, and double vision. The condition can progress through an active phase where inflammation is present, followed by an inactive phase where the inflammation subsides but physical changes may remain. The severity of the disease varies widely among individuals, ranging from mild discomfort to significant changes in eye appearance and function.