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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 study about?

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.

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.

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.

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.

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.

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).

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Centre Hospitalier Universitaire De Lille Lille France
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania

Other Sites

Site Name City Country Status
Delta Health Care S.R.L. Bucharest Romania
University General Hospital Of Heraklion Heraklion Greece
Universita’ Campus Bio-medico Di Roma Rome Italy
Poliklinika Solmed d.o.o. Zagreb Croatia
Enbzoxoroe Kbryugt Skuyufv Thessaloniki Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Croatia Croatia
Not yet recruiting
10.01.2025
France France
Not yet recruiting
10.01.2025
Greece Greece
Not yet recruiting
10.01.2025
Italy Italy
Not yet recruiting
10.01.2025
Poland Poland
Not yet recruiting
10.01.2025
Romania Romania
Not yet recruiting
10.01.2025

Trial locations

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.

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.

Trial ID:
2024-512716-21-00
Protocol code:
RC18G002
NCT ID:
NCT06456567
Trial Phase:
Therapeutic confirmatory (Phase III)

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