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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 (REMESLE-1)
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: Other - Telitacicept
Treatment: Other - Placebo

Experimental: Telitacicept - Telitacicept + Standard of Care (SoC)

Placebo comparator: Placebo - Placebo + Standard of Care (SoC)


Treatment: Other: Telitacicept
Subcutaneous injection weekly for 52 weeks

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

Outcomes
Primary outcome [1] 0 0
SLE Responder Index (SRI-4)
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
SLE Responder Index (SRI-4)
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Achieve and sustain a low dose of corticosteriods
Timepoint [2] 0 0
Weeks 52
Secondary outcome [3] 0 0
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
BILAG-based Combined Lupus Assessment (BICLA) Response
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Time to Flare
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Timepoint [6] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Age 12-70 years at screening.
2. Has a diagnosis of SLE for at least 6 months prior to the screening visit.
3. Meets the 2019 EULAR/ACR Classification criteria for SLE.
4. Moderately to severely active SLE defined by the following:

1. SELENA SLEDAI total score =6 points with clinical SLEDAI score =4 points at screening;
2. BILAG organ system scores of at least 1A or 2B at screening.
5. Clinical SLEDAI score of =4 at Day 0 prior to randomization.
6. At least one positive serologic parameter within the screening period.
7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
2. Active or unstable neuropsychiatric SLE.
3. Autoimmune or rheumatic disease other than SLE

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
Active, not 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
2/03/2027
Actual
Sample size
Target
350
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Argentina
State/province [9] 0 0
Tucuman
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Autonoma Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Cordoba
Country [12] 0 0
Argentina
State/province [12] 0 0
San Juan
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Pleven
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Plovdiv
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Ruse
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sevlievo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Stara Zagora
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Colombia
State/province [20] 0 0
Barranquilla
Country [21] 0 0
Colombia
State/province [21] 0 0
Bucaramanga
Country [22] 0 0
Colombia
State/province [22] 0 0
Medellin
Country [23] 0 0
Colombia
State/province [23] 0 0
Monteria
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein Westfalen
Country [25] 0 0
Guatemala
State/province [25] 0 0
Guatemala
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Debrecen
Country [28] 0 0
Hungary
State/province [28] 0 0
Gyula
Country [29] 0 0
Mauritius
State/province [29] 0 0
Quatre Bornes
Country [30] 0 0
Mexico
State/province [30] 0 0
Ciudad de Mexico
Country [31] 0 0
Mexico
State/province [31] 0 0
Cuernavaca
Country [32] 0 0
Mexico
State/province [32] 0 0
Guadalajara
Country [33] 0 0
Mexico
State/province [33] 0 0
Mexico
Country [34] 0 0
Philippines
State/province [34] 0 0
Batangas
Country [35] 0 0
Philippines
State/province [35] 0 0
Cagayan De Oro
Country [36] 0 0
Philippines
State/province [36] 0 0
Los Baños
Country [37] 0 0
Philippines
State/province [37] 0 0
Makati City
Country [38] 0 0
Philippines
State/province [38] 0 0
Manila
Country [39] 0 0
Poland
State/province [39] 0 0
Bydgoszcz
Country [40] 0 0
Poland
State/province [40] 0 0
Bytom
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Krakow
Country [43] 0 0
Poland
State/province [43] 0 0
Lodz
Country [44] 0 0
Poland
State/province [44] 0 0
Malbork
Country [45] 0 0
Poland
State/province [45] 0 0
Poznan
Country [46] 0 0
Poland
State/province [46] 0 0
Szczecin
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Puerto Rico
State/province [49] 0 0
Caguas
Country [50] 0 0
Puerto Rico
State/province [50] 0 0
San Juan
Country [51] 0 0
Spain
State/province [51] 0 0
Sevilla
Country [52] 0 0
Spain
State/province [52] 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
RC18_SLEstudy@remegenbio.com
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