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Study of Telitacicept compared to placebo in adults with moderate to severe systemic lupus erythematosus

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with Systemic Lupus Erythematosus, an autoimmune disease where the body's immune system attacks its own tissues, causing inflammation and damage to various organs. The study will test a medication called telitacicept, which is given as an injection under the skin using a pre-filled syringe, alongside standard treatments for lupus.

The research aims to determine how well telitacicept works in treating moderate to severe forms of lupus compared to placebo. The study will last 52 weeks, during which participants will receive weekly injections of either telitacicept or placebo. Two different doses of telitacicept will be tested: 160 mg and 240 mg.

Throughout the study, participants will continue their regular lupus medications, which may include glucocorticoids, antimalarial drugs, or other medications that suppress the immune system. The study will monitor how well the treatment works and check for any side effects. Participants will have regular check-ups to assess their lupus symptoms and overall health during the treatment period.

The research process

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

  1. Step 1

    Initial injection visit

    On the first day after joining the trial you receive a subcutaneous injection (a tiny needle placed just under the skin) using a pre‑filled syringe.

    The injection contains either telitacicept 240 mg, telitacicept 160 mg, or a placebo that does not contain active medicine, according to the random assignment.

    The injection is given once per week and you will continue the same dose for the next 52 weeks.

  2. Step 2

    Weekly injection schedule

    Each week you return to the clinic (or a designated site) to receive another subcutaneous injection of the same dose you received at the initial visit.

    The injection is administered with the same pre‑filled syringe each time.

    The weekly injections continue without interruption for a total of 52 weeks.

  3. Step 3

    Mid‑study assessment at week 24

    At week 24 you attend a clinic visit for safety checks and efficacy evaluation.

    The study team measures the SLE Responder Index (SRI‑4), a score that indicates improvement in lupus symptoms.

    Any side effects or health concerns are recorded, and routine blood tests may be performed.

  4. Step 4

    Final assessment at week 52

    At week 52 you complete the last scheduled injection and attend a comprehensive evaluation.

    The primary outcome is the proportion of participants who achieve an SLE Responder Index (SRI‑4) response at this time point.

    Additional measurements include safety monitoring, blood tests for drug levels (pharmacokinetics) and biological activity (pharmacodynamics).

  5. Step 5

    Stage‑2 evaluation (if applicable)

    If, after the first 52 weeks, you have a moderate to severe lupus condition that has not improved sufficiently with the standard treatment, you may be entered into stage 2 of the study.

    Stage 2 focuses on evaluating the benefit of continuing telitacicept beyond week 52, using the same weekly dosing schedule.

    The same efficacy measures (such as SRI‑4 and the BILAG‑based Combined Lupus Assessment) are repeated at week 52 of stage 2.

  6. Step 6

    Ongoing standard of care medication

    Throughout the entire trial you continue to take your usual lupus medicines, known as standard of care treatment, as prescribed by your physician.

    The study does not replace these medications; it adds the weekly injection on top of them.

  7. Step 7

    Glucocorticoid dose management (if required)

    If you are using glucocorticoids (a type of steroid such as prednisone) at a dose higher than 7.5 mg per day at the start of the study, the protocol aims to reduce that dose by at least 25 % by week 40 and keep it at or below 7.5 mg per day through week 52.

    Dose adjustments are made by your physician based on your response and safety assessments.

Who can join the trial?

6 criteria

  • You must have been diagnosed with systemic lupus erythematosus (SLE) for at least 6 months before the screening visit.
  • You need to be an adult (18 years of age or older).
  • Your disease must be moderately to severely active, shown by a score of ≥ 4 on the SLE Disease Activity Index (SLEDAI) measured on the first day of the study.
  • You must have at least one positive serologic lab test (such as antibodies) during the screening period that indicates lupus activity.
  • You must be currently taking at least one standard lupus medication, such as oral glucocorticoids (steroids), an antimalarial drug, or an immunosuppressive agent.
  • Your disease must not be well‑controlled with those standard medicines (an inadequate response to current treatment).

Who cannot join the trial?

6 criteria

  • Having active or unstable neuropsychiatric lupus (when lupus affects the brain or nerves) or lupus nephritis (when lupus harms the kidneys) means you cannot take part.
  • Having any other autoimmune (the immune system attacks the body’s own tissues) or rheumatic (joint or connective‑tissue) disease besides lupus excludes you.
  • Having serious medical problems that are not well controlled and are not related to lupus makes you ineligible.
  • Having a current serious infection caused by viruses, bacteria, or fungi prevents participation.
  • Having been diagnosed with cancer (malignancy) within the past five years disqualifies you.
  • Any other reasons defined in the study’s protocol may also exclude you.
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Investigated drugs

  • Telitacicept injection

    is a medication given under the skin using a pre‑filled syringe. It works by blocking proteins that help immune cells become overactive, which can reduce the inflammation and damage caused by systemic lupus erythematosus (SLE). In the trial, participants receive this injection once a week for a year while continuing their usual lupus medicines.

  • Standard of care (SOC) therapy

    refers to the regular treatments that doctors normally prescribe for SLE, such as anti‑inflammatory steroids and other immune‑modulating drugs. These medicines are used to control disease activity and symptoms, and they are continued alongside the study drug so researchers can see how adding telitacicept affects patients compared with the usual treatment alone.

What is already known about the treatment

Telitacicept - Telitacicept is given as a solution for injection in a pre‑filled syringe that is placed just under the skin once a week. It is an investigational drug that is still being studied in clinical trials and is not yet approved for general use. The medication is being tested for people with moderately to severely active systemic lupus erythematosus, a disease where the immune system attacks the body’s own tissues. It works by attaching to two signaling proteins, called BLyS and APRIL, which stops excess B‑cell activity that contributes to the disease, and it is classified as a biologic immunosuppressant that blocks B‑cell growth.

Investigated diseases

Systemic lupus erythematosus - It is an autoimmune disorder in which the body’s immune system mistakenly attacks its own tissues, causing inflammation. Early signs often include joint pain, skin rash, and fatigue. As the disease becomes more active, inflammation may involve kidneys, heart, lungs, and the nervous system. Patients experience periods where symptoms flare up followed by times of lower activity. The condition can progress with increasing organ involvement if inflammation is not controlled.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500445-24-00Protocol codeRC18G001Estimated enrolment444 patientsSponsorRemegen Co. Ltd.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).