CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus (CHABLIS-SC1)

February 2, 2017 updated by: Anthera Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus, 246029
        • Investigator Site 603
      • Minsk, Belarus, 220037
        • Investigator Site 604
      • Minsk, Belarus, 220116
        • Investigator Site 601
      • Minsk, Belarus, 223040
        • Investigator Site 605
      • Vitebsk, Belarus, 210037
        • Investigator Site 602
  • Brazil
      • Curitiba, Brazil
        • Investigator Site 558
      • Goiania, Brazil, 74110-120
        • Investigator Site 555
      • Juiz de Fora, Brazil, 36010-570
        • Investigator Site 557
      • Porto Alegre, Brazil, 90610-000
        • Investigator Site 551
      • Santo Andre, Brazil
        • Investigator Site 559
      • Sao Paulo, Brazil, 04032-060
        • Investigator Site 554
      • Sao Paulo, Brazil, 13015-001
        • Investigator Site 556
  • Colombia
      • Antioquia, Colombia
        • Investigator Site 302
      • Antioquia, Colombia
        • Investigator Site 303
      • Atlantico, Colombia
        • Investigator Site 308
      • Atlantico, Colombia
        • Investigator Site 310
      • Bogota, Colombia
        • Investigator site 301
      • Bogota, Colombia
        • Investigator Site 311
      • Cundinamarca, Colombia
        • Investigator Site 304
      • Santander, Colombia
        • Investigator Site 305
      • Santander, Colombia
        • Investigator Site 306
      • Valle, Colombia
        • Investigator Site 312
  • Georgia
      • Tbilisi, Georgia, 0186
        • Investigator Site 002
      • Tbilisi, Georgia, 0102
        • Investigator Site 001
      • Tbilisi, Georgia, 0186
        • Investigator Site 003
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Investigator Site 901
      • Guatemala, Guatemala, 01011
        • Investigator Site 902
      • Guatemala, Guatemala
        • Investigator Site 903
      • Guatemala, Guatemala
        • Investigator Site 904
  • Hong Kong
      • Pokfulam, Hong Kong
        • Investigator Site 151
      • Tuen Mun, Hong Kong
        • Investigator Site 152
  • India
      • Ahmedabad, India, 382428
        • Investigator Site 503
      • Bangalore, India, 560034
        • Investigator Site 508
      • Hyderabad, India, 500 082
        • Investigator Site 505
      • Hyderabad, India, 500 096
        • Investigator Site 502
      • Kolkata, India, 700054
        • Investigator Site 501
      • Manipal, India, 576 104
        • Investigator Site 506
      • Mumbai, India, 400053
        • Investiagtor Site 513
      • New Delhi, India, 110 060
        • Investigator Site 511
      • New Delhi, India, 110 076
        • Investigator Site 512
      • Pune, India, 411 001
        • Investigator Site 504
      • Pune, India, 411007
        • Investigator Site 510
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Investigator Site 355
      • Daejeon, Korea, Republic of, 301-721
        • Investigator Site 352
      • Gwangju, Korea, Republic of, 501-757
        • Investigator Site 353
      • Jeollabuk-do, Korea, Republic of, 561-712
        • Investigator Site 351
      • Suwon, Korea, Republic of, 443-721
        • Investigator Site 354
  • Malaysia
      • Perak, Malaysia
        • Investigator Site 252
      • Selangor, Malaysia
        • Investigator Site 251
  • Mexico
      • Guanajuato, Mexico, 37000
        • Investigator Site 702
      • Mexico City, Mexico, 07760
        • Investigator Site 703
      • Mexico City, Mexico, 14000
        • Investigator Site 701
      • Mexico City, Mexico, 97133
        • Investigator Site 704
      • Toluca, Mexico, 50120
        • Investigator Site 707
      • Yucatan, Mexico, 97133
        • Investigator Site 705
  • Philippines
      • Angeles, Philippines, 2009
        • Investigator Site 407
      • Cebu City, Philippines, 6000
        • Investigator Site 404
      • Cebu City, Philippines, 6000
        • Investigator Site 406
      • Cruz Manila, Philippines, 1003
        • Investigator Site 408
      • Davao, Philippines, 8000
        • Investigator Site 405
      • Ermita, Manila, Philippines, 1000
        • Investigator Site 402
      • Iloilo City, Philippines, 5000
        • Investigator Site 410
      • Las Pinas City, Philippines, 1742
        • Investigator Site 401
      • Manila, Philippines, 1008
        • Investigator Site 403
      • Manila, Philippines
        • Investigator Site 409
  • Russian Federation
      • Kemerovo, Russian Federation, 650000
        • Investigator Site 052
      • Kemerovo, Russian Federation, 650029
        • Investigator Site 053
      • Kursk, Russian Federation, 305007
        • Investigator Site 054
      • Moscow, Russian Federation
        • Investigator Site 051
      • Novosibirsk, Russian Federation, 630091
        • Investigator Site 058
      • Omsk, Russian Federation
        • Investigator Site 059
      • Orenburg, Russian Federation, 460000
        • Investigator Site 062
      • Petrozavodsk, Russian Federation, 185019
        • Investigator Site 057
      • Saint Petersburg, Russian Federation, 192242
        • Investigator Site 056
      • Smolensk, Russian Federation, 214025
        • Investigator Site 061
      • Vladimir, Russian Federation, 600023
        • Investigator Site 060
      • Yekaterinburg, Russian Federation, 620102
        • Investigator Site 055
  • Singapore
      • Singapore, Singapore, 119228
        • Investigator site 101
  • Sri Lanka
      • Colombo, Sri Lanka
        • Investigator Site 801
      • Kandy, Sri Lanka
        • Investigator Site 804
      • Nugegoda, Sri Lanka
        • Investigator Site 802
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Investigator Site 452
      • Taichung, Taiwan, 40447
        • Investigator Site 455
      • Taichung, Taiwan
        • Investigator Site 454
      • Taipei City, Taiwan, 100
        • Investigator Site 453
      • Taipei City, Taiwan, 110
        • Investigator Site 451
  • Thailand
      • Bangkok Noi, Thailand, 10700
        • Investigator site 205
      • Khon Kaen, Thailand, 40002
        • Investigator site 202
      • Muang Chiang Mai, Thailand, 50200
        • Investigator site 204
      • Ratchathewi, Thailand, 10400
        • Investigator site 201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
  • Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
  • Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
  • 18 years of age or older

Exclusion Criteria:

  • Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes
  • Malignancy within past 5 years
  • Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
  • Liver disease
  • Anemia, neutropenia, or thrombocytopenia
  • Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
  • History of active tuberculosis or a history of tuberculosis infection
  • Pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks
EXPERIMENTAL: blisibimod weekly dose
Drug: blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving an SLE Responder Index at week 52
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in proteinuria from baseline
Time Frame: Week 52
Week 52
Proportion of subjects with improved patient-reported outcomes
Time Frame: Week 52
Week 52
Time to first severe SLE flare
Time Frame: Week 52
Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
Time Frame: Week 52
Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Time Frame: Week 52
Week 52
Time to treatment failure
Time Frame: Week 52
Week 52
Time to first renal flare
Time Frame: Week 52
Week 52
Change from baseline in B cell subsets, anti dsDNA, C3, C4
Time Frame: Week 52
Week 52
Safety Profile (AEs, vital signs, labs, physical exams)
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (ESTIMATE)

July 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-SLE3331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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