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
Sites (32)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DCC 1 Sevlievo EOOD Coordinator of this site? Confirm its status | Sevlievo | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Dkc Fokus-5 Lzip OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Universitatsklinikum Munster AöR Coordinator of this site? Confirm its status | Münster | Germany | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Withdrawn |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Coordinator of this site? Confirm its status | Budapest IX | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Bekes Megyei Kozponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Centrum Medyczne INTERCOR Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Krakowskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Vita Longa Sp. Z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Centra Medyczne Medyceusz Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o Coordinator of this site? Confirm its status | Malbork | Poland | Completed |
| Ai Centrum Medyczne Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Termedia Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Somed Cr Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Reuma Research Anna Boryczka Trefler Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.