Clinical trial NCT05306574: A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
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 (REMESLE-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
SLE
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (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 study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment in a global patient population with active SLE disease.

* Stage 1: a study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of two treatment arms of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment.
* Stage 2: a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to SoC compared to placebo with SoC therapy in patients with moderately to severely active SLE.

Eligibility criteria: 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.

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

Primary outcomes:
measure: SLE Responder Index (SRI-4)
timeFrame: Week 52
Secondary outcomes:
measure: SLE Responder Index (SRI-4)
timeFrame: Week 24
measure: Achieve and sustain a low dose of corticosteriods
timeFrame: Weeks 52
measure: SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
timeFrame: Week 52
measure: BILAG-based Combined Lupus Assessment (BICLA) Response
timeFrame: Week 52
measure: Time to Flare
timeFrame: Week 52
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Week 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Anniston, Alabama Site
state: Alabama
city: Mission Hills
country: United States
facility: Mission Hills Site
state: California
city: Orange
country: United States
facility: Orange Site
state: California
city: Thousand Oaks
country: United States
facility: Thousands Oaks Site
state: California
city: Miami
country: United States
facility: Miami, FL Site
state: Florida
city: Tampa
country: United States
facility: Tampa, Florida Site
state: Florida
city: Wheaton
country: United States
facility: Wheaton, Maryland Site
state: Maryland
city: Grand Blanc
country: United States
facility: Grand Blanc Site
state: Michigan
city: Baytown
country: United States
facility: Baytown Site
state: Texas
city: Colleyville
country: United States
facility: Colleyville, Texas Site
state: Texas
city: Houston
country: United States
facility: Houston Site
state: Texas
city: Waco
country: United States
facility: Waco Site
state: Texas
city: Quilmes
country: Argentina
facility: Quilmes Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Rosario Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: San Miguel de Tucuman Site 1
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: San Miguel de Tucuman Site 2
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Ciudad Autonoma Buenos Aires Site 2
city: Cordoba
country: Argentina
facility: Cordoba Site
city: San Juan
country: Argentina
facility: San Juan Site
city: Garran
country: Australia
facility: Garran Site
state: Austl. Cap. Terr.
city: Murdoch
country: Australia
facility: Murdoch Site
state: Western Australia
city: Pleven
country: Bulgaria
facility: Pleven Site
city: Plovdiv
country: Bulgaria
facility: Plovdiv Site
city: Ruse
country: Bulgaria
facility: Ruse Site
city: Sevlievo
country: Bulgaria
facility: Sevlievo Site
city: Sofia
country: Bulgaria
facility: Sofia Site 1
city: Sofia
country: Bulgaria
facility: Sofia Site 4
city: Sofia
country: Bulgaria
facility: Sofia Site 5
city: Sofia
country: Bulgaria
facility: Sofia Site 3
city: Stara Zagora
country: Bulgaria
facility: Stara Zagora Site
city: Santiago
country: Chile
facility: Santiago Site 4
city: Santiago
country: Chile
facility: Santiago Site 1
city: Santiago
country: Chile
facility: Santiago Site 3
city: Santiago
country: Chile
facility: Santiago Site 2
city: Barranquilla
country: Colombia
facility: Barranquilla site
city: Barranquilla
country: Colombia
facility: Barranquilla site
city: Bucaramanga
country: Colombia
facility: Bucaramanga site
city: Medellin
country: Colombia
facility: Medellin Site 1
city: Medellin
country: Colombia
facility: Medellin site 2
city: Monteria
country: Colombia
facility: Monteria site
city: Koeln
country: Germany
facility: Koeln Site
state: Nordrhein Westfalen
city: Muenster
country: Germany
facility: Muenster Site
state: Nordrhein Westfalen
city: Guatemala
country: Guatemala
facility: Guatemala site
city: Budapest
country: Hungary
facility: Budapest Site
city: Debrecen
country: Hungary
facility: Debrecen Site
city: Gyula
country: Hungary
facility: Gyula Site
city: Quatre Bornes
country: Mauritius
facility: Quatre Bornes Site
city: Ciudad de Mexico
country: Mexico
facility: Ciudad de Mexico Site
city: Cuernavaca
country: Mexico
facility: Cuernavaca Site
city: Guadalajara
country: Mexico
facility: Guadalajara Site
city: Mexico
country: Mexico
facility: Mexico site 1
city: Mexico
country: Mexico
facility: Mexico Site 2
city: Batangas
country: Philippines
facility: Batangas Site
city: Cagayan De Oro
country: Philippines
facility: Cagayan de Oro City Site
city: Los Baños
country: Philippines
facility: Los Baños Site
city: Makati City
country: Philippines
facility: Makati City Site
city: Manila
country: Philippines
facility: Manila Site
city: Bydgoszcz
country: Poland
facility: Bydgoszcz Site
city: Bydgoszcz
country: Poland
facility: Bydgoszcz Site 2
city: Bydgoszcz
country: Poland
facility: Bydgoszcz Site 3
city: Bytom
country: Poland
facility: Bytom Site
city: Katowice
country: Poland
facility: Katowice Site
city: Krakow
country: Poland
facility: Krakow Site 1
city: Lodz
country: Poland
facility: Lodz Site
city: Malbork
country: Poland
facility: Malbork Site
city: Poznan
country: Poland
facility: Poznan Site 2
city: Poznan
country: Poland
facility: Poznan SIte
city: Poznań
country: Poland
facility: Poznań Site
city: Szczecin
country: Poland
facility: Szczecin Site
city: Warszawa
country: Poland
facility: Warszawa Site 2
city: Warszawa
country: Poland
facility: Warszawa Site 3
city: Warszawa
country: Poland
facility: Warszawa Site
city: Wroclaw
country: Poland
facility: Wroclaw Site 2
city: Caguas
country: Puerto Rico
facility: Caguas Site
city: San Juan
country: Puerto Rico
facility: San Juan Site
city: Sevilla
country: Spain
facility: Sevilla Site 1
city: Sevilla
country: Spain
facility: Sevilla Site 2
city: Valencia
country: Spain
facility: Valencia Site
Study officials:
References: