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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05306574




Registration number
NCT05306574
Ethics application status
Date submitted
23/03/2022
Date registered
1/04/2022

Titles & IDs
Public title
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
Scientific title
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
Secondary ID [1] 0 0
RC18G001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Telitacicept
Treatment: Drugs - Placebo

Experimental: Telitacicept 160 mg - Telitacicept 160 mg + SOC

Experimental: Telitacicept 240 mg - Telitacicept 240 mg + SOC

Placebo comparator: Placebo - Placebo + SOC


Treatment: Drugs: Telitacicept
subcutaneous injection weekly for 52 weeks

Treatment: Drugs: Placebo
subcutaneous injection weekly for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Key secondary endpoint for Stage 2: achieve and sustain a low dose of corticosteroid
Timepoint [2] 0 0
Weeks 40 - 52
Secondary outcome [3] 0 0
Key secondary endpoint for Stage 2: Annualized severe flare rate
Timepoint [3] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.
2. Moderate to severely active SLE is defined by the following:

1. Hybrid SELENA SLEDAI (hSLEDAI) total score = 6 at screening with clinical hSLEDAI score = 4 points
2. BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
3. Clinical hSLEDAI score of = 4 at Day 0 prior to randomization
4. At least one positive serologic parameter within the screening period
5. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
6. Other protocol defined inclusion criteria may apply.
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active or unstable neuropsychiatric SLE or lupus nephritis
2. Autoimmune or rheumatic disease other than SLE
3. Significant, uncontrolled medical conditions not related to SLE
4. Active and/or severe viral, bacterial or fungal infection
5. History of malignancy within 5 years
6. Other protocol defined exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/09/2025
Actual
Sample size
Target
341
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Austl. Cap. Terr.WA
Recruitment hospital [1] 0 0
Garran Site - Garran
Recruitment hospital [2] 0 0
Murdoch Site - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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North Carolina
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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San Juan
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Bulgaria
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Kardzhali
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sevlievo
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Chile
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Santiago
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Chile
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Viña del Mar
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Bucaramanga
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Colombia
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Medellin
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Colombia
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Monteria
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Germany
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Nordrhein Westfalen
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Philippines
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Batangas
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Philippines
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Cagayan De Oro
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Philippines
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Los Baños
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Philippines
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Makati City
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Philippines
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Manila
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Poland
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Bydgoszcz
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Poland
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Bytom
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Malbork
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Poland
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Poznan
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Poland
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Sosnowiec
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
State/province [50] 0 0
Caguas
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Puerto Rico
State/province [51] 0 0
San Juan
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Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Granada
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Spain
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Sevilla
Country [55] 0 0
Spain
State/province [55] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RemeGen Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
RemeGen
Address 0 0
Country 0 0
Phone 0 0
301-284-1015
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05306574