Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
ADDRESS II
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)
2 other identifiers
interventional
306
18 countries
138
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Typical duration for phase_2
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
October 26, 2017
CompletedJanuary 2, 2018
December 1, 2017
2.3 years
October 24, 2013
September 29, 2017
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
Week 24
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
Week 24
Secondary Outcomes (7)
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
Week 24
Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24
Week 24
Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24
Screening and Week 24
Time From Randomization to First SRI Response During Treatment Period
Baseline up to 24 Weeks
Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24
Week 24
- +2 more secondary outcomes
Study Arms (3)
Atacicept 75 mg
EXPERIMENTALAtacicept 150 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (138)
Pinnacle Research Group LLC
Anniston, Alabama, 36207, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
University of Alabama at Birmingham - (UAB)
Birmingham, Alabama, 35294, United States
Southern California Permanente Medical Group
Anaheim, California, 92806, United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, 94578, United States
Clinical Research of West Florida - Corporate
Dunedin, Florida, 34698, United States
Center for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, 33309, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
North MS Medical Clinics, Inc.
Tupelo, Mississippi, 38801, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
The Feinstein Institute for Medical Research
Manhasset, New York, 11031, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Box Arthritis & Rheumatology of the Carolinas PLLC
Charlotte, North Carolina, 28210, United States
MetroHealth System
Cleveland, Ohio, 44109, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
STAT Research, Inc.
Dayton, Ohio, 45417, United States
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
OMRF
Oklahoma City, Oklahoma, 73104, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, 19610, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
UTMB Pathology Clinical Services
Galveston, Texas, 77555, United States
Arthritis & Osteoporosis Clinic
Waco, Texas, 76708, United States
Danville Orthopedic Clinic, Inc.
Danville, Virginia, 24541, United States
APRILLUS
Ciudad Autonoma Buenos Aires, Argentina
Atencion Integral en Reumatologia (AIR)
Ciudad Autonoma Buenos Aires, Argentina
Hospital Italiano
Ciudad Autonoma Buenos Aires, Argentina
Organizacion Medica de Investigacion (OMI)
Ciudad Autonoma Buenos Aires, Argentina
Policlìnica Red Omip S.A - Ensayos Clinicos GC
Mar del Plata, Argentina
Centro de Investigacion Pergamino SA
Pergamino, Argentina
Cordis S.A.
Salta, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER
San Juan, Argentina
Centro Integral de Reumatologia
San Miguel de Tucumán, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Argentina
CPD - Centro de Pesquisas em Diabetes
Porto Alegre, Brazil
CLION - Clínica de Oncologia da Bahia
Salvador, Brazil
Clínica de Neoplasias Litoral Ltda.
Santa Catarina, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, Bulgaria
Medical Center "Teodora", EOOD
Rousse, Bulgaria
DCC "Sveta Anna", EOOD
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, Bulgaria
MHAT-Targovishte, AD
Targovishte, Bulgaria
Biomedica
Santiago, Chile
Centro de Estudios Reumatologicos
Santiago, Chile
Centro Medico Prosalud
Santiago, Chile
SOMEAL
Santiago, Chile
CINVEC - Centro de Investigacion Clinica V Region
Viña del Mar, Chile
A-Shine, s.r.o.
Pilsen, Czechia
Revmatologicky Ustav
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, Czechia
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
Bari, Italy
Presidio Ospedaliero Vittorio Emanuele
Catania, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
St. Luke's International Hospital
Chūōku, Japan
NHO Kyushu Medical Center
Fukuoka, Japan
Toho University Ohashi Medical Center
Meguro-ku, Japan
Okayama University Hospital
Okayama, Japan
Kitasato University Hospital
Sagamihara-shi, Japan
Hokkaido University Hospital
Sapporo, Japan
Sapporo City General Hospital
Sapporo, Japan
Hakujujikai Sasebochuo Hospital
Sasebo-shi, Japan
Tohoku University Hospital
Sendai, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Japan
National Center for Global Health and Medicine Hospital
Shinjuku, Japan
Yuaikai Tomishiro Chuo Hospital
Tomigusuku-shi, Japan
Tsukuba University Hospital
Tsukuba, Japan
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, Mexico
Icle S.C.
Guadalajara, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
Guadalajara, Mexico
Investigacion Clinica de Leon S.C.
León, Mexico
Morales Vargas Centro de Investigacion, S.C.
León, Mexico
Centro de Estudios Clinicos Especializados
Mérida, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Mexico
ALIVIA Clínica de Alta Especialidad S.A. de C.V.
Monterrey, Mexico
Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
Morelia, Mexico
Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
Saltillo, Mexico
Clinica El Golf
Lima, Peru
Clinica Medica Cayetano Heredia
Lima, Peru
Clinica Vesalio
Lima, Peru
HMA - Hospital Maria Auxiliadora
Lima, Peru
Angeles University Foundation Medical Center
Angeles City, Philippines
Mary Mediatrix Medical Center
Batangas, Philippines
Davao Doctors Hospital
Davao City, Philippines
Iloilo Doctors Hospital
Iloilo City, Philippines
St. Luke's Medical Center
Quezon City, Philippines
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
Torun, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, Poland
Wojskowy Instytut Medyczny
Warsaw, Poland
SBEI HPE Altai State Medical University of MoH and SD
Barnaul, Russia
SBHI of Kem. "Regional Clinical Hospital for War Veterans"
Kemerovo, Russia
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Russia
Municipal City Hospital #2
Omsk, Russia
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, Russia
Clinical Rheumatology Hospital #25
Saint Petersburg, Russia
Out - patient Clinic # 107
Saint Petersburg, Russia
City Clinical Hospital #12
Saratov, Russia
Regional Clinical Hospital
Saratov, Russia
Regional Clinical Hospital
Vladimir, Russia
Yaroslavl State Medical University
Yaroslavl, Russia
Dr CE Spargo and Dr RB Bhorat
Cape Town, South Africa
Naidoo, A
Durban, South Africa
Winelands Medical Research Centre
Stellenbosch, South Africa
Gachon University Gil Medical Center
Incheon, South Korea
Konkuk University Medical Center
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital de Sagunto
Sagunto, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Royal National Hospital for Rheumatic Diseases
Bath, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Guy's Hospital
London, United Kingdom
University College London Hospitals
London, United Kingdom
Wrightington Hospital
Wigan, United Kingdom
Related Publications (3)
Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.
PMID: 37332136DERIVEDMorand 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.
PMID: 32107560DERIVEDMerrill 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.
PMID: 29073347DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
October 30, 2013
Study Start
December 1, 2013
Primary Completion
April 1, 2016
Study Completion
September 1, 2016
Last Updated
January 2, 2018
Results First Posted
October 26, 2017
Record last verified: 2017-12