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NCT05306574CompletedPhase 3

A Phase 3 Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients with Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Jan 2025

Brief summary (registry, in English)

Stage 1: To evaluate the efficacy, safety, PK and PD of telitacicept 160 mg and 240 mg administered as a subcutaneous injection via prefilled syringes (PFS) weekly for 52 weeks in adult patients with active SLE while receiving SOC treatment. Stage 2: To evaluate the efficacy of telitacicept at Week 52 in adult subjects with moderately to severely active SLE with an inadequate response to SoC therapy.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
146 (actual)
First submitted
31 May 2022
Start date
30 Nov 2022
Lead sponsor
Remegen Co. Ltd.
Diseases
Lupus (SLE)
NCT number
NCT05306574
EU CT number
2022-500445-24-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 146
  • 32 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Autoimmune or rheumatic disease other than SLE
  • Significant, uncontrolled medical conditions not related to SLE
  • Active and/or severe viral, bacterial or fungal infection
  • History of malignancy within 5 years

Other

  • Active or unstable neuropsychiatric SLE or lupus nephritis
  • Other protocol defined exclusion criteria may apply.

Who the study is looking for

  • Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.
  • Stage 2: To evaluate the efficacy of telitacicept at Week 24 in adult subjects with moderately to severely active SLE with inadequate response to SoC therapy.
  • Clinical SLEDAI score of ≥ 4 at Day 0 prior to randomization
  • At least one positive serologic parameter within the screening period
  • Currently receiving at least one of the SoC SLE therapies: oral GCs, antimalarial and/or immunosuppressive agent.
  • Other protocol defined inclusion criteria may apply.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (32)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
DCC 1 Sevlievo EOOD
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SevlievoBulgariaCompleted
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Diagnostic-Consultative Center Alexandrovska EOOD
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
Dkc Fokus-5 Lzip OOD
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
University Hospital Cologne AöR
Coordinator of this site? Confirm its status
CologneGermanyCompleted
Klinikum der Universitaet Muenchen AöR
Coordinator of this site? Confirm its status
MunichGermanyCompleted
Universitatsklinikum Munster AöR
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MünsterGermanyCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Clínico San Cecilio
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GranadaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Quironsalud Infanta Luisa
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SevillaSpainCompleted
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainCompleted
Centre Hospitalier Universitaire De Caen Normandie
Coordinator of this site? Confirm its status
Caen Cedex 9FranceWithdrawn
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Bekes Megyei Kozponti Korhaz
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GyulaHungaryCompleted
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandCompleted
Centrum Medyczne INTERCOR Sp. z o.o.
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BydgoszczPolandCompleted
Krakowskie Centrum Medyczne Sp. z o.o.
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CracowPolandCompleted
Vita Longa Sp. Z o.o.
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KatowicePolandCompleted
Centra Medyczne Medyceusz Sp. z o.o.
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LodzPolandCompleted
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o
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MalborkPolandCompleted
Ai Centrum Medyczne Sp. z o.o. S.K.
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PoznanPolandCompleted
Termedia Sp. z o.o.
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PoznanPolandCompleted
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
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SzczecinPolandCompleted
Somed Cr Sp. z o.o. sp.k.
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WarsawPolandCompleted
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandCompleted
Reuma Research Anna Boryczka Trefler
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WarsawPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.