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

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telitacicept
Placebo
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Anniston, Alabama Site
  • Birmingham, Alabama SiteRecruiting
  • Huntington Park, California SiteRecruiting
  • La Mesa SiteRecruiting
  • Mission Hills SiteRecruiting
  • Thousands Oaks Site
  • Debary, Florida SiteRecruiting
  • Fort Lauderdale, FL SiteRecruiting
  • Miami, FL Site
  • Orlando SiteRecruiting
  • Tampa, Florida SiteRecruiting
  • Rockford SiteRecruiting
  • Wheaton, Maryland Site
  • Grand Blanc SiteRecruiting
  • Eagan SiteRecruiting
  • Salisbury SiteRecruiting
  • Baytown SiteRecruiting
  • Colleyville, Texas SiteRecruiting
  • Houston Site
  • Waco SiteRecruiting
  • Quilmes Site
  • Rosario Site
  • San Miguel de Tucuman Site 1
  • San Miguel de Tucuman Site 2
  • Ciudad Autonoma Buenos Aires Site 2
  • Cordoba Site
  • San Juan Site
  • Garran Site
  • Murdoch SiteRecruiting
  • Kardzhali SiteRecruiting
  • Pleven SiteRecruiting
  • Plovdiv SiteRecruiting
  • Ruse SiteRecruiting
  • Sevlievo SiteRecruiting
  • Sofia Site 1Recruiting
  • Sofia Site 4Recruiting
  • Sofia Site 5Recruiting
  • Sofia Site 2Recruiting
  • Sofia Site 3
  • Stara Zagora SiteRecruiting
  • Santiago Site 4Recruiting
  • Santiago Site 1Recruiting
  • Santiago Site 3
  • Santiago Site 2Recruiting
  • Viña del Mar Site
  • Barranquilla site
  • Barranquilla site
  • Bogotá site
  • Bucaramanga site
  • Medellin Site 1
  • Medellin site 2
  • Monteria site
  • Koeln SiteRecruiting
  • Muenster Site
  • Budapest Site
  • Debrecen SiteRecruiting
  • Gyula SiteRecruiting
  • Batangas Site
  • Cagayan de Oro City SiteRecruiting
  • Los Baños SiteRecruiting
  • Makati City Site
  • Manila Site
  • Bydgoszcz SiteRecruiting
  • Bydgoszcz Site 2Recruiting
  • Bydgoszcz Site 3Recruiting
  • Bytom SiteRecruiting
  • Katowice SiteRecruiting
  • Krakow Site 2Recruiting
  • Krakow Site 1Recruiting
  • Lodz SiteRecruiting
  • Lodz Site 2Recruiting
  • Malbork SiteRecruiting
  • Poznan Site 2Recruiting
  • Poznan SIteRecruiting
  • Poznań SiteRecruiting
  • Sosnowiec Site
  • Szczecin Site
  • Warszawa Site 2Recruiting
  • Warszawa Site 3Recruiting
  • Warszawa SiteRecruiting
  • Wroclaw Site 2
  • Wroclaw SiteRecruiting
  • Caguas SiteRecruiting
  • San Juan SiteRecruiting
  • Barcelona Site
  • Granada SiteRecruiting
  • Sevilla Site 1Recruiting
  • Sevilla Site 2Recruiting
  • Valencia SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Telitacicept 160 mg

Telitacicept 240 mg

Placebo

Arm Description

Telitacicept 160 mg + SOC

Telitacicept 240 mg + SOC

Placebo + SOC

Outcomes

Primary Outcome Measures

Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)
Proportion of patients achieving a response in SRI-4
Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)
Proportion of patients achieving a response in SRI-4

Secondary Outcome Measures

Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA)
Proportion of patients achieving a response in BICLA
Key secondary endpoint for Stage 2: achieve and sustain a low dose of corticosteroid
Proportion of patients who achieve or maintain prednisone </= 7.5 mg/d or equivalent
Key secondary endpoint for Stage 2: Annualized severe flare rate
Severe flare according to the SLEDAI Flare Index (SFI)

Full Information

First Posted
March 23, 2022
Last Updated
September 1, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05306574
Brief Title
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
June 29, 2025 (Anticipated)
Study Completion Date
September 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
Detailed Description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities. Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL).Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, BCMA, and BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses, and may alleviate autoimmune symptoms. This Phase 3 study is a 2-stage operationally seamless study to evaluate the efficacy and safety of telitacicept 160 mg and 240 mg in a global patient population with active SLE disease. Stage 1 - a dose ranging study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of telitacicept 160 mg and 240 mg in an international cohort of adult SLE patients. Stage 2 - a confirmatory efficacy study to evaluate the telitacicept dose selected from Stage 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
341 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telitacicept 160 mg
Arm Type
Experimental
Arm Description
Telitacicept 160 mg + SOC
Arm Title
Telitacicept 240 mg
Arm Type
Experimental
Arm Description
Telitacicept 240 mg + SOC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + SOC
Intervention Type
Drug
Intervention Name(s)
Telitacicept
Other Intervention Name(s)
RC18
Intervention Description
subcutaneous injection weekly for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection weekly for 52 weeks
Primary Outcome Measure Information:
Title
Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)
Description
Proportion of patients achieving a response in SRI-4
Time Frame
Week 24
Title
Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)
Description
Proportion of patients achieving a response in SRI-4
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA)
Description
Proportion of patients achieving a response in BICLA
Time Frame
Week 52
Title
Key secondary endpoint for Stage 2: achieve and sustain a low dose of corticosteroid
Description
Proportion of patients who achieve or maintain prednisone </= 7.5 mg/d or equivalent
Time Frame
Weeks 40 - 52
Title
Key secondary endpoint for Stage 2: Annualized severe flare rate
Description
Severe flare according to the SLEDAI Flare Index (SFI)
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has had a diagnosis of SLE for at least 6 months prior to the screening Visit. Moderate to severely active SLE is defined by the following: Hybrid SELENA SLEDAI (hSLEDAI) total score ≥ 6 at screening with clinical hSLEDAI score ≥ 4 points BILAG-2004 organ system scores of at least 1 A or 2 B at screening. Clinical hSLEDAI 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 medications: oral corticosteroid, antimalarial and/or immunosuppressive agent. Other protocol defined inclusion criteria may apply. Exclusion Criteria: Active or unstable neuropsychiatric SLE or lupus nephritis 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 protocol defined exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RemeGen
Phone
301-284-1015
Email
RC18_SLEstudy@remegenbio.com
Facility Information:
Facility Name
Anniston, Alabama Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Completed
Facility Name
Birmingham, Alabama Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntington Park, California Site
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Name
La Mesa Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Mission Hills Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Individual Site Status
Recruiting
Facility Name
Thousands Oaks Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Completed
Facility Name
Debary, Florida Site
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Lauderdale, FL Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami, FL Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Completed
Facility Name
Orlando Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa, Florida Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Rockford Site
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Individual Site Status
Recruiting
Facility Name
Wheaton, Maryland Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Individual Site Status
Completed
Facility Name
Grand Blanc Site
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Name
Eagan Site
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Name
Salisbury Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Name
Baytown Site
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Individual Site Status
Recruiting
Facility Name
Colleyville, Texas Site
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Individual Site Status
Completed
Facility Name
Waco Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Name
Quilmes Site
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Rosario Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
San Miguel de Tucuman Site 1
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
San Miguel de Tucuman Site 2
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000ICL
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Ciudad Autonoma Buenos Aires Site 2
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Cordoba Site
City
Cordoba
ZIP/Postal Code
X5000AVE
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
San Juan Site
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Garran Site
City
Garran
State/Province
Austl. Cap. Terr.
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Murdoch Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Kardzhali Site
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Pleven Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Plovdiv Site
City
Plovdiv
ZIP/Postal Code
4023
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Ruse Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Sevlievo Site
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Sofia Site 1
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Sofia Site 4
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Sofia Site 5
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Sofia Site 2
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Sofia Site 3
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Stara Zagora Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Santiago Site 4
City
Santiago
ZIP/Postal Code
7500010
Country
Chile
Individual Site Status
Recruiting
Facility Name
Santiago Site 1
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Name
Santiago Site 3
City
Santiago
ZIP/Postal Code
7501126
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Santiago Site 2
City
Santiago
ZIP/Postal Code
8330336
Country
Chile
Individual Site Status
Recruiting
Facility Name
Viña del Mar Site
City
Viña del Mar
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Barranquilla site
City
Barranquilla
ZIP/Postal Code
080002
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Barranquilla site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Bogotá site
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Bucaramanga site
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Medellin Site 1
City
Medellin
ZIP/Postal Code
050025
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Medellin site 2
City
Medellin
ZIP/Postal Code
50021
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Monteria site
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Koeln Site
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Muenster Site
City
Muenster
State/Province
Nordrhein Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Budapest Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Debrecen Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Gyula Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Batangas Site
City
Batangas
ZIP/Postal Code
4217
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Cagayan de Oro City Site
City
Cagayan De Oro
ZIP/Postal Code
9000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Los Baños Site
City
Los Baños
ZIP/Postal Code
4030
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Makati City Site
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Manila Site
City
Manila
ZIP/Postal Code
1012
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Bydgoszcz Site
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Individual Site Status
Recruiting
Facility Name
Bydgoszcz Site 2
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Bydgoszcz Site 3
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Individual Site Status
Recruiting
Facility Name
Bytom Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
Katowice Site
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakow Site 2
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakow Site 1
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lodz Site
City
Lodz
ZIP/Postal Code
90-368
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lodz Site 2
City
Lodz
ZIP/Postal Code
91-053
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malbork Site
City
Malbork
ZIP/Postal Code
82-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Poznan Site 2
City
Poznan
ZIP/Postal Code
60-681
Country
Poland
Individual Site Status
Recruiting
Facility Name
Poznan SIte
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Individual Site Status
Recruiting
Facility Name
Poznań Site
City
Poznań
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Sosnowiec Site
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Szczecin Site
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Warszawa Site 2
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Warszawa Site 3
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Warszawa Site
City
Warszawa
ZIP/Postal Code
04-305
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wroclaw Site 2
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Wroclaw Site
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
Caguas Site
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
San Juan Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Barcelona Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Granada Site
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sevilla Site 1
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sevilla Site 2
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Valencia Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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