Clinical trial NCT01972568: Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Official title: A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Keywords: Atacicept
Placebo
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2013-10-30
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Eligible male and female subjects, aged 18 years or older
* Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to \[\>=\] 6 at screening visit
* At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed \>= 6 months prior to the screening visit)
* Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Subjects have demyelinating disorder
* Severe central nervous system SLE
* Use of cyclophosphamide within 3 months of the screening visit
* Urine protein:creatinine ratio (UPCr) \>= 2 milligram per milligram (mg/mg) per day
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
timeFrame: Week 24
measure: Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity
timeFrame: Week 24
measure: Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24
timeFrame: Week 24
measure: Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24
timeFrame: Screening and Week 24
measure: Time From Randomization to First SRI Response During Treatment Period
timeFrame: Baseline up to 24 Weeks
measure: Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24
timeFrame: Week 24
measure: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)
measure: Change From Week 0 (Day 1) in SF-36 Components at Week 24
timeFrame: Week 0 (Day 1) and Week 24
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group LLC
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - (UAB)
state: Alabama
city: Anaheim
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc.
state: California
city: Dunedin
country: United States
facility: Clinical Research of West Florida - Corporate
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology & Arthritis
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Grand Blanc
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tupelo
country: United States
facility: North MS Medical Clinics, Inc.
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: Box Arthritis & Rheumatology of the Carolinas PLLC
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: OMRF
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Galveston
country: United States
facility: UTMB Pathology Clinical Services
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic
state: Texas
city: Danville
country: United States
facility: Danville Orthopedic Clinic, Inc.
state: Virginia
city: Ciudad Autonoma Buenos aires
country: Argentina
facility: APRILLUS
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Atencion Integral en Reumatologia (AIR)
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion (OMI)
city: Mar De Plata
country: Argentina
facility: Policlìnica Red Omip S.A - Ensayos Clinicos GC
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Salta
country: Argentina
facility: Cordis S.A.
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clinicas Tucuman
city: San Miguel de Tucumán
country: Argentina
facility: Centro Integral de Reumatologia
city: Porto Alegre
country: Brazil
facility: CPD - Centro de Pesquisas em Diabetes
city: Salvador
country: Brazil
facility: CLION - Clínica de Oncologia da Bahia
city: Santa Catarina
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: Plovdiv
country: Bulgaria
facility: MHAT "Eurohospital" - Plovdiv, OOD
city: Ruse
country: Bulgaria
facility: Medical Center "Teodora", EOOD
city: Sofia
country: Bulgaria
facility: DCC "Sveta Anna", EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Targovishte
country: Bulgaria
facility: MHAT-Targovishte, AD
city: Santiago
country: Chile
facility: Biomedica
city: Santiago
country: Chile
facility: Centro de Estudios Reumatologicos
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: SOMEAL
city: Vina del Mar
country: Chile
facility: CINVEC - Centro de Investigacion Clinica V Region
city: Plzen
country: Czechia
facility: A-Shine, s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky Ustav
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
city: Catania
country: Italy
facility: Presidio Ospedaliero Vittorio Emanuele
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Medical Center
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sapporo-shi
country: Japan
facility: Sapporo City General Hospital
city: Sasebo-shi
country: Japan
facility: Hakujujikai Sasebochuo Hospital
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine Hospital
city: Tomigusuku-shi
country: Japan
facility: Yuaikai Tomishiro Chuo Hospital
city: Tsukuba-shi
country: Japan
facility: Tsukuba University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Guadalajara
country: Mexico
facility: Icle S.C.
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
city: Leon
country: Mexico
facility: Investigacion Clinica de Leon S.C.
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
city: Merida
country: Mexico
facility: Centro de Estudios Clinicos Especializados
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
city: Monterrey
country: Mexico
facility: ALIVIA Clínica de Alta Especialidad S.A. de C.V.
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
city: Lima
country: Peru
facility: Clinica El Golf
city: Lima
country: Peru
facility: Clinica Medica Cayetano Heredia
city: Lima
country: Peru
facility: Clinica Vesalio
city: Lima
country: Peru
facility: HMA - Hospital Maria Auxiliadora
city: Angeles City
country: Philippines
facility: Angeles University Foundation Medical Center
city: Batangas
country: Philippines
facility: Mary Mediatrix Medical Center
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo City
country: Philippines
facility: Iloilo Doctors Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Torun
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
city: Warsaw
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Barnaul
country: Russian Federation
facility: SBEI HPE Altai State Medical University of MoH and SD
city: Kemerovo
country: Russian Federation
facility: SBHI of Kem. "Regional Clinical Hospital for War Veterans"
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M. Sechenov
city: Omsk
country: Russian Federation
facility: Municipal City Hospital #2
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a. V.A. Baranov
city: Saratov
country: Russian Federation
facility: City Clinical Hospital #12
city: Saratov
country: Russian Federation
facility: Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Clinical Rheumatology Hospital #25
city: St. Petersburg
country: Russian Federation
facility: Out - patient Clinic # 107
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical University
city: Cape Town
country: South Africa
facility: Dr CE Spargo and Dr RB Bhorat
city: Durban
country: South Africa
facility: Naidoo, A
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sagunto
country: Spain
facility: Hospital de Sagunto
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Bath
country: United Kingdom
facility: Royal National Hospital for Rheumatic Diseases
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: University College London Hospitals
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
Study officials:
affiliation: EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Morand EF, Isenberg DA, Wallace DJ, Kao AH, Vazquez-Mateo C, Chang P, Pudota K, Aranow C, Merrill JT. Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study. Rheumatology (Oxford). 2020 Oct 1;59(10):2930-2938. doi: 10.1093/rheumatology/keaa029.
citation: Merrill JT, Wallace DJ, Wax S, Kao A, Fraser PA, Chang P, Isenberg D; ADDRESS II Investigators. Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study. Arthritis Rheumatol. 2018 Feb;70(2):266-276. doi: 10.1002/art.40360.