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

This study has been completed.
Information provided by (Responsible Party):
EMD Serono Identifier:
First received: October 24, 2013
Last updated: January 3, 2017
Last verified: January 2017
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 Intervention Phase
Lupus Erythematosus, Systemic Drug: Atacicept 75 milligram (mg) Drug: Atacicept 150 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percentage of subjects with SLE responder index (SRI) response at Week 24 compared to screening [ Time Frame: Screening and Week 24 ]

Secondary Outcome Measures:
  • Percentage of subjects at Week 24 whose prednisone-equivalent corticosteroid dose has reduced from Screening by >= 25 percent and to a dose of =< 7.5 milligram per day (mg/day), and have no BILAG A or 2B flare in disease activity during Weeks 16 to 24 [ Time Frame: Screening and Week 24 ]
  • Percentage of subjects in the patient global impression of change (PGIC) categories at Week 24 [ Time Frame: Week 24 ]
  • Change from screening visit to Week 24 in prednisone-equivalent corticosteroid (CS) daily dose [ Time Frame: Screening and Week 24 ]
  • Time to first SRI response during the treatment period [ Time Frame: 24 Weeks ]
  • Percentage of subjects responding to treatment according to British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) [ Time Frame: Week 24 ]
  • Change from Day 1 in medical outcomes study 36-item short form health survey (SF-36)-physical component summary (PCS) and mental component summary (MCS) [ Time Frame: Week 24 ]
  • Number of subjects with adverse events (AEs) [ Time Frame: Screening up to 48 weeks ]

Enrollment: 306
Study Start Date: December 2013
Study Completion Date: September 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01972568

  Show 138 Study Locations
Sponsors and Collaborators
EMD Serono
Study Director: Medical Responsible EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
  More Information

Responsible Party: EMD Serono Identifier: NCT01972568     History of Changes
Other Study ID Numbers: 700461-023
2013-002773-21 ( EudraCT Number )
Study First Received: October 24, 2013
Last Updated: January 3, 2017

Keywords provided by EMD Serono:
Atacicept 75 and 150 mg

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017