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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medicover Integrated Clinical Services Sp. z o.o.	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Pomeranian Medical University	Szczecin	Poland
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland
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Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
University Of Debrecen	Debrecen	Hungary
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Ludwig Maximilian University Of Munich	Munich	Germany
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Ai Centrum Medyczne Sp. z o.o.	Poznan	Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.	Malbork	Poland
Centra Medyczne Medyceusz Sp. z o.o.	Lodz	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
Centrum Medyczne Intercor Sp. z o.o.	Bydgoszcz	Poland
Termedia Sp. z o.o.	Poznan	Poland
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler	Warsaw	Poland
Medical Center 1 Sevlievo EOOD	Sevlievo	Bulgaria
Mtasbcjga Igsezuarvv Cspjawxj Syuefvhb Skw z ofqt	Warsaw	Poland
Ulzpaddfiy Hksntahd Crrffgk	Cologne	Germany
Uhijhfmcgydtzabksbrfp Mcxfvffm Aze	Munster	Germany
Sivgl Cf Saq z odkw sydil	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	24.10.2022
Czechia	Not yet recruiting	24.10.2022
France	Not yet recruiting	24.10.2022
Germany	Not recruiting	24.10.2022
Hungary	Not recruiting	24.10.2022
Poland	Not recruiting	24.10.2022
Spain	Not recruiting	24.10.2022

Trial locations

Investigated drugs:

Telitacicept

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.

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 ID:

2022-500445-24-00

Protocol code:

RC18G001

NCT ID:

NCT05306574

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?