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Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus (ADDRESS II)

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ClinicalTrials.gov Identifier: NCT01972568
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : October 26, 2017
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

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).

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Atacicept 75 milligram (mg) Drug: Atacicept 150 mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Atacicept 75 mg Drug: Atacicept 75 milligram (mg)
Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.

Experimental: Atacicept 150 mg Drug: Atacicept 150 mg
Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.

Placebo Comparator: Placebo Drug: Placebo
Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.




Primary Outcome Measures :
  1. Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline [ Time Frame: Week 24 ]
    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.

  2. Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline [ Time Frame: Week 24 ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Week 24 ]
    BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.

  2. Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 [ Time Frame: Week 24 ]
    The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.

  3. Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24 [ Time Frame: Screening and Week 24 ]
    Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.

  4. Time From Randomization to First SRI Response During Treatment Period [ Time Frame: Baseline up to 24 Weeks ]
    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. Time to first SRI response during treatment period was presented.

  5. Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24 [ Time Frame: Week 24 ]
    The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.

  6. Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks) ]
    An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.

  7. Change From Week 0 (Day 1) in SF-36 Components at Week 24 [ Time Frame: Week 0 (Day 1) and Week 24 ]
    The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972568


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Locations
United States, Alabama
Pinnacle Research Group LLC
Anniston, Alabama, United States, 36207
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
University of Alabama at Birmingham - (UAB)
Birmingham, Alabama, United States, 35294
United States, California
Southern California Permanente Medical Group
Anaheim, California, United States, 92806
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, United States, 94578
United States, Florida
Clinical Research of West Florida - Corporate
Dunedin, Florida, United States, 34698
Center for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, United States, 33309
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
United States, Indiana
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States, 46260
United States, Michigan
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States, 48439
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
North MS Medical Clinics, Inc.
Tupelo, Mississippi, United States, 38801
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11031
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Box Arthritis & Rheumatology of the Carolinas PLLC
Charlotte, North Carolina, United States, 28210
United States, Ohio
MetroHealth System
Cleveland, Ohio, United States, 44109
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
STAT Research, Inc.
Dayton, Ohio, United States, 45417
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
OMRF
Oklahoma City, Oklahoma, United States, 73104
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
UTMB Pathology Clinical Services
Galveston, Texas, United States, 77555
Arthritis & Osteoporosis Clinic
Waco, Texas, United States, 76708
United States, Virginia
Danville Orthopedic Clinic, Inc.
Danville, Virginia, United States, 24541
Argentina
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 De 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 Medico Privado de Reumatologia
San Miguel de Tucuman, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucuman, Argentina
Centro Integral de Reumatologia
San Miguel de Tucumán, Argentina
Brazil
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
Bulgaria
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, Bulgaria
Medical Center "Teodora", EOOD
Ruse, 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
Chile
Biomedica
Santiago, Chile
Centro de Estudios Reumatologicos
Santiago, Chile
Centro Medico Prosalud
Santiago, Chile
SOMEAL
Santiago, Chile
CINVEC - Centro de Investigacion Clinica V Region
Vina del Mar, Chile
Czechia
A-Shine, s.r.o.
Plzen, Czechia
Revmatologicky Ustav
Praha 2, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2, Czechia
MEDICAL PLUS s.r.o.
Uherske Hradiste, Czechia
Germany
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, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany
Italy
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
Bari, Italy
Presidio Ospedaliero Vittorio Emanuele
Catania, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Japan
St. Luke's International Hospital
Chuo-ku, Japan
NHO Kyushu Medical Center
Fukuoka-shi, Japan
Toho University Ohashi Medical Center
Meguro-ku, Japan
Okayama University Hospital
Okayama-shi, Japan
Kitasato University Hospital
Sagamihara-shi, Japan
Hokkaido University Hospital
Sapporo-shi, Japan
Sapporo City General Hospital
Sapporo-shi, Japan
Hakujujikai Sasebochuo Hospital
Sasebo-shi, Japan
Tohoku University Hospital
Sendai-shi, 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-shi, Japan
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon-si, Korea, Republic of
Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua, Mexico
Icle S.C.
Guadalajara, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
Guadalajara, Mexico
Investigacion Clinica de Leon S.C.
Leon, Mexico
Morales Vargas Centro de Investigacion, S.C.
Leon, Mexico
Centro de Estudios Clinicos Especializados
Merida, 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
Peru
Clinica El Golf
Lima, Peru
Clinica Medica Cayetano Heredia
Lima, Peru
Clinica Vesalio
Lima, Peru
HMA - Hospital Maria Auxiliadora
Lima, Peru
Philippines
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
Poland
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
Warszawa, Poland
Russian Federation
SBEI HPE Altai State Medical University of MoH and SD
Barnaul, Russian Federation
SBHI of Kem. "Regional Clinical Hospital for War Veterans"
Kemerovo, Russian Federation
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Russian Federation
Municipal City Hospital #2
Omsk, Russian Federation
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, Russian Federation
City Clinical Hospital #12
Saratov, Russian Federation
Regional Clinical Hospital
Saratov, Russian Federation
Clinical Rheumatology Hospital #25
St. Petersburg, Russian Federation
Out - patient Clinic # 107
St. Petersburg, Russian Federation
Regional Clinical Hospital
Vladimir, Russian Federation
Yaroslavl State Medical University
Yaroslavl, Russian Federation
South Africa
Dr CE Spargo and Dr RB Bhorat
Cape Town, South Africa
Naidoo, A
Durban, South Africa
Winelands Medical Research Centre
Stellenbosch, South Africa
Spain
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
United Kingdom
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
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01972568     History of Changes
Other Study ID Numbers: 700461-023
2013-002773-21 ( EudraCT Number )
First Posted: October 30, 2013    Key Record Dates
Results First Posted: October 26, 2017
Last Update Posted: January 2, 2018
Last Verified: December 2017

Keywords provided by EMD Serono:
Atacicept
Placebo

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases