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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by EMD Serono
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01972568
First received: October 24, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Percentage of subjects in the patient global impression of change (PGIC) categories at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from screening visit to Week 24 in prednisone-equivalent corticosteroid (CS) daily dose [ Time Frame: Screening and Week 24 ] [ Designated as safety issue: No ]
  • Time to first SRI response during the treatment period [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects responding to treatment according to British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events (AEs) [ Time Frame: Screening up to 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 279
Study Start Date: November 2013
Estimated Study Completion Date: April 2016
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01972568

Contacts
Contact: US Medical Information 888-275-7376
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com

Locations
United States, Massachusetts
For Recruiting Locations in the United States, please Contact U.S. Medical Information Located in Recruiting
Rockland, Massachusetts, United States
Contact    888-275-7376      
Bulgaria
Please Contact the Merck KGaA Communication Center Recruiting
Targovishte, Bulgaria
Contact    +49 6151 72 5200    service@merckgroup.com   
Czech Republic
Please Contact the Merck KGaA Communication Center Recruiting
Uherske Hradiste, Czech Republic
Contact    +49 6151 72 5200    service@merckgroup.com   
Germany
Please Contact the Merck KGaA Communication Center Recruiting
Bad Nauheim, Germany
Contact    +49 6151 72 5200    service@merckgroup.com   
Italy
Please contact the Merck KGaA Communication Center Recruiting
Milan, Italy
Contact    +49 6151 72 5200    service@merckgroup.com   
Korea, Republic of
Please contact the Merck KGaA Communication Center Recruiting
Seoul, Korea, Republic of
Contact    +49 6151 72 5200    service@merckgroup.com   
United Kingdom
Please contact the Merck KGaA Communication Center Recruiting
Westcliff-on-Sea, United Kingdom
Contact    +49 6151 72 5200    service@merckgroup.com   
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01972568     History of Changes
Other Study ID Numbers: 700461-023, 2013-002773-21
Study First Received: October 24, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by EMD Serono:
Atacicept 75 and 150 mg
Placebo

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

ClinicalTrials.gov processed this record on September 22, 2014