AzTrials
AzTrials

Lupus Erythematosus, SystemicPhase 2ADDRESS IINCT01972568

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

A Phase 2 study testing Atacicept 75 milligram (mg) and Atacicept 150 mg in people with Lupus Erythematosus, Systemic, run by EMD Serono at 138 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Atacicept 75 milligram (mg) and Atacicept 150 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
306 participants
Where
138 sitesin 18 countries
Study dates
Dec 2013to Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

138 sites in 18 countries.

138 sites in 18 countries

United States30 sites

  • Southern California Permanente Medical Group

    Anaheim, California, 92806

  • Pinnacle Research Group LLC

    Anniston, Alabama, 36207

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • University of Alabama at Birmingham - (UAB)

    Birmingham, Alabama, 35294

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Box Arthritis & Rheumatology of the Carolinas PLLC

    Charlotte, North Carolina, 28210

  • MetroHealth System

    Cleveland, Ohio, 44109

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Danville Orthopedic Clinic, Inc.

    Danville, Virginia, 24541

  • STAT Research, Inc.

    Dayton, Ohio, 45417

  • Clinical Research of West Florida - Corporate

    Dunedin, Florida, 34698

  • Center for Rheumatology, Immunology & Arthritis

    Fort Lauderdale, Florida, 33309

  • UTMB Pathology Clinical Services

    Galveston, Texas, 77555

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11031

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Hospital for Special Surgery

    New York, New York, 10021

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Arthritis & Rheumatology Center of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • OMRF

    Oklahoma City, Oklahoma, 73104

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • East Bay Rheumatology Medical Group, Inc.

    San Leandro, California, 94578

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • North MS Medical Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Arthritis & Osteoporosis Clinic

    Waco, Texas, 76708

  • Clinical Research Center of Reading LLC

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan13 sites

  • St. Luke's International Hospital

    Chūōku

  • NHO Kyushu Medical Center

    Fukuoka

  • Toho University Ohashi Medical Center

    Meguro-ku

  • Okayama University Hospital

    Okayama

  • Kitasato University Hospital

    Sagamihara-shi

  • Hokkaido University Hospital

    Sapporo

  • Sapporo City General Hospital

    Sapporo

  • Hakujujikai Sasebochuo Hospital

    Sasebo-shi

  • Tohoku University Hospital

    Sendai

  • Jichi Medical University Hospital

    Shimotsuke-shi

  • National Center for Global Health and Medicine Hospital

    Shinjuku

  • Yuaikai Tomishiro Chuo Hospital

    Tomigusuku-shi

  • Tsukuba University Hospital

    Tsukuba

Other trials in Japan

Argentina11 sites

  • APRILLUS

    Ciudad Autonoma Buenos Aires

  • Atencion Integral en Reumatologia (AIR)

    Ciudad Autonoma Buenos Aires

  • Hospital Italiano

    Ciudad Autonoma Buenos Aires

  • Organizacion Medica de Investigacion (OMI)

    Ciudad Autonoma Buenos Aires

  • Policlìnica Red Omip S.A - Ensayos Clinicos GC

    Mar del Plata

  • Centro de Investigacion Pergamino SA

    Pergamino

  • Cordis S.A.

    Salta

  • Centro Polivalente de Asistencia e Inv. Clinica CER

    San Juan

  • Centro Integral de Reumatologia

    San Miguel de Tucumán

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán

Other trials in Argentina

Russia11 sites

  • SBEI HPE Altai State Medical University of MoH and SD

    Barnaul

  • SBHI of Kem. "Regional Clinical Hospital for War Veterans"

    Kemerovo

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow

  • Municipal City Hospital #2

    Omsk

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk

  • Clinical Rheumatology Hospital #25

    Saint Petersburg

  • Out - patient Clinic # 107

    Saint Petersburg

  • City Clinical Hospital #12

    Saratov

  • Regional Clinical Hospital

    Saratov

  • Regional Clinical Hospital

    Vladimir

  • Yaroslavl State Medical University

    Yaroslavl

Other trials in Russia

Mexico10 sites

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City

  • Icle S.C.

    Guadalajara

  • Unidad de Investigacion en Enfermedades Cronico Degenerativas SC

    Guadalajara

  • Investigacion Clinica de Leon S.C.

    León

  • Morales Vargas Centro de Investigacion, S.C.

    León

  • Centro de Estudios Clinicos Especializados

    Mérida

  • Accelerium S. de R.L. de C.V.

    Monterrey

  • ALIVIA Clínica de Alta Especialidad S.A. de C.V.

    Monterrey

  • Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.

    Morelia

  • Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"

    Saltillo

Other trials in Mexico

Germany7 sites

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau

  • Rheumazentrum Ruhrgebiet

    Herne

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz

Other trials in Germany

Bulgaria6 sites

  • MHAT "Eurohospital" - Plovdiv, OOD

    Plovdiv

  • Medical Center "Teodora", EOOD

    Rousse

  • DCC "Sveta Anna", EOOD

    Sofia

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora

  • MHAT-Targovishte, AD

    Targovishte

Other trials in Bulgaria

Italy6 sites

  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari

    Bari

  • Presidio Ospedaliero Vittorio Emanuele

    Catania

  • Azienda Ospedaliera Universitaria Careggi

    Florence

  • Azienda Ospedaliero Universitaria San Martino

    Genova

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

Other trials in Italy

United Kingdom6 sites

  • Royal National Hospital for Rheumatic Diseases

    Bath

  • Royal Sussex County Hospital

    Brighton

  • University Hospital Coventry

    Coventry

  • Guy's Hospital

    London

  • University College London Hospitals

    London

  • Wrightington Hospital

    Wigan

Other trials in United Kingdom

Chile5 sites

  • Biomedica

    Santiago

  • Centro de Estudios Reumatologicos

    Santiago

  • Centro Medico Prosalud

    Santiago

  • SOMEAL

    Santiago

  • CINVEC - Centro de Investigacion Clinica V Region

    Viña del Mar

Other trials in Chile

Philippines5 sites

  • Angeles University Foundation Medical Center

    Angeles City

  • Mary Mediatrix Medical Center

    Batangas

  • Davao Doctors Hospital

    Davao City

  • Iloilo Doctors Hospital

    Iloilo City

  • St. Luke's Medical Center

    Quezon City

Other trials in Philippines

South Korea5 sites

  • Gachon University Gil Medical Center

    Incheon

  • Konkuk University Medical Center

    Seoul

  • Kyung Hee University Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Brazil4 sites

  • CPD - Centro de Pesquisas em Diabetes

    Porto Alegre

  • CLION - Clínica de Oncologia da Bahia

    Salvador

  • Clínica de Neoplasias Litoral Ltda.

    Santa Catarina

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto

Other trials in Brazil

Czechia4 sites

  • A-Shine, s.r.o.

    Pilsen

  • Revmatologicky Ustav

    Prague

  • Vseobecna fakultni nemocnice v Praze

    Prague

  • MEDICAL PLUS s.r.o.

    Uherské Hradiště

Other trials in Czechia

Peru4 sites

  • Clinica El Golf

    Lima

  • Clinica Medica Cayetano Heredia

    Lima

  • Clinica Vesalio

    Lima

  • HMA - Hospital Maria Auxiliadora

    Lima

Other trials in Peru

Poland4 sites

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz

  • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

    Torun

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw

  • Wojskowy Instytut Medyczny

    Warsaw

Other trials in Poland

Spain4 sites

  • Hospital General Universitario Gregorio Marañon

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital de Sagunto

    Sagunto

  • Hospital Clínico Universitario de Valladolid

    Valladolid

Other trials in Spain

South Africa3 sites

  • Dr CE Spargo and Dr RB Bhorat

    Cape Town

  • Naidoo, A

    Durban

  • Winelands Medical Research Centre

    Stellenbosch

Other trials in South Africa

About this study

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)

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

Being tested
Atacicept 75 milligram (mg), Atacicept 150 mg, Placebo
Keywords
Atacicept, Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atacicept 75 milligram (mg)Drug

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

  • Atacicept 150 mgDrug

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

  • PlaceboDrug

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

Study groups in NCT01972568
Study groupRoleWhat they receive
Atacicept 75 mgExperimentalNot described
Receives: Drug: Atacicept 75 milligram (mg)
Atacicept 150 mgExperimentalNot described
Receives: Drug: Atacicept 150 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

Secondary outcomes (7)

  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

    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.

    Measured: Week 24

  2. Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at 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.

    Measured: Week 24

  3. Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24

    Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.

    Measured: Screening and Week 24

  4. Time From Randomization to First SRI Response During Treatment Period

    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.

    Measured: Baseline up to 24 Weeks

  5. Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at 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.

    Measured: Week 24

  6. Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    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.

    Measured: Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)

  7. Change From Week 0 (Day 1) in SF-36 Components at 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.

    Measured: Week 0 (Day 1) and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionApr 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972568
Sponsor's protocol ID
700461-023
Other IDs
2013-002773-21
Acronym
ADDRESS II
Status last verified
Dec 2017
First submitted
24 Oct 2013
Last updated
2 Jan 2018

Publications

  • 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.

    PubMed 37332136

  • 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.

    PubMed 32107560

  • 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.

    PubMed 29073347

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atacicept 75 milligram (mg) and Atacicept 150 mg in people with Lupus Erythematosus, Systemic, run by EMD Serono at 138 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Japan, Argentina, Russia, Mexico and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01972568, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in