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Study on the Effectiveness of Telitacicept for Adults with Moderate to Severe Systemic Lupus Erythematosus

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called Telitacicept for people with Systemic Lupus Erythematosus (SLE)</b), which is a condition where the immune system mistakenly attacks healthy tissues in the body. The study aims to evaluate how effective and safe Telitacicept is for patients who have moderate to severe symptoms of this disease and have not responded well to standard treatments. Participants in the study will receive either the Telitacicept injection or a matching placebo, which is a substance with no active medication.

The study will last for about 52 weeks, during which participants will receive regular injections. The treatment is administered through a pre-filled syringe as a subcutaneous injection, meaning it is injected under the skin. Throughout the study, participants will be monitored to see how their symptoms change and to check for any side effects. The goal is to see if Telitacicept can help reduce the symptoms of SLE and improve the quality of life for those affected by this condition.

Participants will be assessed at various points during the study to determine their response to the treatment. The main focus is on the proportion of patients who show improvement in their symptoms by the end of the study. Additionally, the study will look at other factors, such as the ability to reduce the use of other medications like prednisone, which is often used to manage SLE symptoms. The safety of the treatment will also be closely monitored to ensure it is well-tolerated by participants.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.
A physical examination and laboratory tests are performed to establish baseline health status.
Step 2
Randomization
Participants are randomly assigned to receive either the telitacicept injection or a matching placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment administration
The assigned treatment is administered as a subcutaneous injection using a pre-filled syringe.
The treatment is given once a week for a total duration of 52 weeks.
Step 4
Regular monitoring
Participants attend regular follow-up visits to monitor health status and response to treatment.
These visits include physical examinations, laboratory tests, and assessments of lupus activity.
Step 5
Primary evaluation
At Week 52, the primary evaluation is conducted to assess the effectiveness of the treatment.
The main measure is the proportion of participants achieving a response according to the SLE Responder Index (SRI-4).
Step 6
Secondary evaluations
Secondary evaluations occur at various points, including Week 24 and Week 52, to assess additional outcomes such as changes in medication dosage and overall health improvements.
These evaluations also monitor any adverse effects and changes in vital signs.
Step 7
Completion and follow-up
After completing the 52-week treatment period, participants undergo a final assessment to evaluate long-term effects and overall health.
Participants are advised to continue regular medical care and monitoring as needed.

Who can join the trial?
11 criteria

Patients must be between 12 and 70 years old at the time of screening.
Patients must have a confirmed diagnosis of **Systemic Lupus Erythematosus (SLE)** for at least 6 months before the screening visit.
Patients must have **moderately to severely active SLE**, which means their disease is active and not well controlled.
Patients must be currently receiving at least one standard treatment for SLE, such as oral **glucocorticoids (GCs)**, **antimalarials**, or **immunosuppressants**. These are medications that help control the immune system.
Women who can have children must use highly effective birth control methods during the study and for at least 4 months after the last dose of the study medication. They must also have a negative pregnancy test before starting the study.
Men who are not sterilized and are sexually active with a woman who can have children must also use effective birth control methods during the study and for at least 4 months after the last dose of the study medication.
All patients must agree not to donate blood, sperm, or eggs while taking the study medication and for at least 4 months after the last dose.
Patients must be appropriately vaccinated according to their doctor's judgment and local guidelines. This includes vaccines for illnesses like pneumococcus, influenza, and COVID-19.
Patients must weigh at least 35 kg (about 77 pounds) at screening and at the start of the study.
Patients must meet specific criteria for SLE activity, including certain scores on tests that measure disease activity.
Patients must have positive results for certain antibodies, which are proteins made by the immune system, or other specific markers related to SLE.

Who cannot join the trial?
8 criteria

Patients who have a different condition than Moderately to Severely Active Systemic Lupus Erythematosus cannot participate.
Patients who are not adults cannot participate. This means only those who are 18 years or older can join.
Patients who have responded well to standard treatments for their condition cannot participate. The study is for those who have not had a good response to usual treatments.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain other medical conditions that might interfere with the study cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Centre Hospitalier Universitaire De Lille
Verified
Lille, France
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania
Universita' Campus Bio-medico Di Roma
Verified
Rome, Italy
Trial locations
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Investigated drugs

Telitacicept is a medication being studied for its effectiveness in treating patients with moderately to severely active systemic lupus erythematosus (SLE). It is being tested to see if it can help improve symptoms in patients who have not responded well to standard treatments.

Telitacicept

What is already known about the treatment

Telitacicept – Telitacicept is administered via injection and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active systemic lupus erythematosus (SLE). It is in the phase 3 stage of clinical trials, which means it is being tested for safety and efficacy in a larger group of patients. The main therapeutic indication for telitacicept is systemic lupus erythematosus, a chronic autoimmune disease. At the molecular level, telitacicept works by targeting specific proteins involved in the immune response, helping to reduce inflammation and disease activity. It is classified pharmacologically as a biologic agent, specifically designed to modulate the immune system.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever. The disease can vary greatly in severity and may have periods of flares and remissions. Over time, SLE can lead to inflammation and damage in the affected organs. The progression of the disease can be unpredictable, with symptoms ranging from mild to severe.