Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

NCT ID: NCT01972568

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-09-30

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).

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Atacicept 75 mg

Group Type: EXPERIMENTAL

Atacicept 75 milligram (mg)

Intervention Type: DRUG

Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.

Atacicept 150 mg

Group Type: EXPERIMENTAL

Atacicept 150 mg

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Atacicept 75 milligram (mg)

Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.

Intervention Type: DRUG

Atacicept 150 mg

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Locations

Pinnacle Research Group LLC

Anniston, Alabama, United States

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

University of Alabama at Birmingham - (UAB)

Birmingham, Alabama, United States

Southern California Permanente Medical Group

Anaheim, California, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

East Bay Rheumatology Medical Group, Inc.

San Leandro, California, United States

Clinical Research of West Florida - Corporate

Dunedin, Florida, United States

Center for Rheumatology, Immunology & Arthritis

Fort Lauderdale, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, United States

AA MRC LLC Ahmed Arif Medical Research Center

Grand Blanc, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

North MS Medical Clinics, Inc.

Tupelo, Mississippi, United States

Washington University School of Medicine

St Louis, Missouri, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

The Feinstein Institute for Medical Research

Manhasset, New York, United States

Hospital for Special Surgery

New York, New York, United States

Box Arthritis & Rheumatology of the Carolinas PLLC

Charlotte, North Carolina, United States

MetroHealth System

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

STAT Research, Inc.

Dayton, Ohio, United States

Arthritis & Rheumatology Center of Oklahoma

Oklahoma City, Oklahoma, United States

OMRF

Oklahoma City, Oklahoma, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Clinical Research Center of Reading LLC

Wyomissing, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

UTMB Pathology Clinical Services

Galveston, Texas, United States

Arthritis & Osteoporosis Clinic

Waco, Texas, United States

Danville Orthopedic Clinic, Inc.

Danville, Virginia, 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

Countries

United States; Argentina; Brazil; Bulgaria; Chile; Czechia; Germany; Italy; Japan; Mexico; Peru; Philippines; Poland; Russia; South Africa; South Korea; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37332136 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32107560 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29073347 (View on PubMed)

Other Identifiers

2013-002773-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

700461-023

Identifier Type: -

Identifier Source: org_study_id