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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
blisibimod
Placebo
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site 603
  • Investigator Site 604
  • Investigator Site 601
  • Investigator Site 605
  • Investigator Site 602
  • Investigator Site 558
  • Investigator Site 555
  • Investigator Site 557
  • Investigator Site 551
  • Investigator Site 559
  • Investigator Site 554
  • Investigator Site 556
  • Investigator Site 302
  • Investigator Site 303
  • Investigator Site 308
  • Investigator Site 310
  • Investigator Site 301
  • Investigator Site 311
  • Investigator Site 304
  • Investigator Site 305
  • Investigator Site 306
  • Investigator Site 312
  • Investigator Site 001
  • Investigator Site 002
  • Investigator Site 003
  • Investigator Site 901
  • Investigator Site 902
  • Investigator Site 903
  • Investigator Site 904
  • Investigator Site 151
  • Investigator Site 152
  • Investigator Site 503
  • Investigator Site 508
  • Investigator Site 505
  • Investigator Site 502
  • Investigator Site 501
  • Investigator Site 506
  • Investiagtor Site 513
  • Investigator Site 511
  • Investigator Site 512
  • Investigator Site 504
  • Investigator Site 510
  • Investigator Site 355
  • Investigator Site 352
  • Investigator Site 353
  • Investigator Site 351
  • Investigator Site 354
  • Investigator Site 252
  • Investigator Site 251
  • Investigator Site 702
  • Investigator Site 703
  • Investigator Site 701
  • Investigator Site 704
  • Investigator Site 707
  • Investigator Site 705
  • Investigator Site 407
  • Investigator Site 404
  • Investigator Site 406
  • Investigator Site 408
  • Investigator Site 405
  • Investigator Site 402
  • Investigator Site 410
  • Investigator Site 401
  • Investigator Site 403
  • Investigator Site 409
  • Investigator Site 052
  • Investigator Site 053
  • Investigator Site 054
  • Investigator Site 051
  • Investigator Site 058
  • Investigator Site 059
  • Investigator Site 062
  • Investigator Site 057
  • Investigator Site 056
  • Investigator Site 061
  • Investigator Site 060
  • Investigator Site 055
  • Investigator Site 101
  • Investigator Site 801
  • Investigator Site 804
  • Investigator Site 802
  • Investigator Site 452
  • Investigator Site 455
  • Investigator Site 454
  • Investigator Site 453
  • Investigator Site 451
  • Investigator Site 205
  • Investigator Site 202
  • Investigator Site 204
  • Investigator Site 201

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

blisibimod weekly dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients achieving an SLE Responder Index at week 52

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2011
Last Updated
February 2, 2017
Sponsor
Anthera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01395745
Brief Title
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
Acronym
CHABLIS-SC1
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blisibimod weekly dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
blisibimod
Intervention Description
blisibimod administered via subcutaneous injection every week for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered weekly via subcutaneous injection for 52 weeks
Primary Outcome Measure Information:
Title
Proportion of patients achieving an SLE Responder Index at week 52
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Time to first severe SLE flare
Time Frame
Week 52
Title
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
Time Frame
Week 52
Title
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Time Frame
Week 52
Title
Change in proteinuria from baseline
Time Frame
Week 52
Title
Proportion of subjects with improved patient-reported outcomes
Time Frame
Week 52
Title
Time to treatment failure
Time Frame
Week 52
Title
Time to first renal flare
Time Frame
Week 52
Title
Change from baseline in B cell subsets, anti dsDNA, C3, C4
Time Frame
Week 52
Title
Safety Profile (AEs, vital signs, labs, physical exams)
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigator Site 603
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Investigator Site 604
City
Minsk
ZIP/Postal Code
220037
Country
Belarus
Facility Name
Investigator Site 601
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Investigator Site 605
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Investigator Site 602
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Investigator Site 558
City
Curitiba
Country
Brazil
Facility Name
Investigator Site 555
City
Goiania
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Investigator Site 557
City
Juiz de Fora
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Investigator Site 551
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Investigator Site 559
City
Santo Andre
Country
Brazil
Facility Name
Investigator Site 554
City
Sao Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Investigator Site 556
City
Sao Paulo
ZIP/Postal Code
13015-001
Country
Brazil
Facility Name
Investigator Site 302
City
Antioquia
Country
Colombia
Facility Name
Investigator Site 303
City
Antioquia
Country
Colombia
Facility Name
Investigator Site 308
City
Atlantico
Country
Colombia
Facility Name
Investigator Site 310
City
Atlantico
Country
Colombia
Facility Name
Investigator Site 301
City
Bogota
Country
Colombia
Facility Name
Investigator Site 311
City
Bogota
Country
Colombia
Facility Name
Investigator Site 304
City
Cundinamarca
Country
Colombia
Facility Name
Investigator Site 305
City
Santander
Country
Colombia
Facility Name
Investigator Site 306
City
Santander
Country
Colombia
Facility Name
Investigator Site 312
City
Valle
Country
Colombia
Facility Name
Investigator Site 001
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Investigator Site 002
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Investigator Site 003
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Investigator Site 901
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Investigator Site 902
City
Guatemala
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
Investigator Site 903
City
Guatemala
Country
Guatemala
Facility Name
Investigator Site 904
City
Guatemala
Country
Guatemala
Facility Name
Investigator Site 151
City
Pokfulam
Country
Hong Kong
Facility Name
Investigator Site 152
City
Tuen Mun
Country
Hong Kong
Facility Name
Investigator Site 503
City
Ahmedabad
ZIP/Postal Code
382428
Country
India
Facility Name
Investigator Site 508
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Investigator Site 505
City
Hyderabad
ZIP/Postal Code
500 082
Country
India
Facility Name
Investigator Site 502
City
Hyderabad
ZIP/Postal Code
500 096
Country
India
Facility Name
Investigator Site 501
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Investigator Site 506
City
Manipal
ZIP/Postal Code
576 104
Country
India
Facility Name
Investiagtor Site 513
City
Mumbai
ZIP/Postal Code
400053
Country
India
Facility Name
Investigator Site 511
City
New Delhi
ZIP/Postal Code
110 060
Country
India
Facility Name
Investigator Site 512
City
New Delhi
ZIP/Postal Code
110 076
Country
India
Facility Name
Investigator Site 504
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
Investigator Site 510
City
Pune
ZIP/Postal Code
411007
Country
India
Facility Name
Investigator Site 355
City
Daegu
Country
Korea, Republic of
Facility Name
Investigator Site 352
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Investigator Site 353
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Investigator Site 351
City
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Investigator Site 354
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Investigator Site 252
City
Perak
Country
Malaysia
Facility Name
Investigator Site 251
City
Selangor
Country
Malaysia
Facility Name
Investigator Site 702
City
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Investigator Site 703
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Investigator Site 701
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Investigator Site 704
City
Mexico City
ZIP/Postal Code
97133
Country
Mexico
Facility Name
Investigator Site 707
City
Toluca
ZIP/Postal Code
50120
Country
Mexico
Facility Name
Investigator Site 705
City
Yucatan
ZIP/Postal Code
97133
Country
Mexico
Facility Name
Investigator Site 407
City
Angeles
ZIP/Postal Code
2009
Country
Philippines
Facility Name
Investigator Site 404
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Investigator Site 406
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Investigator Site 408
City
Cruz Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Investigator Site 405
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Investigator Site 402
City
Ermita, Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Investigator Site 410
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Investigator Site 401
City
Las Pinas City
ZIP/Postal Code
1742
Country
Philippines
Facility Name
Investigator Site 403
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Investigator Site 409
City
Manila
Country
Philippines
Facility Name
Investigator Site 052
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Investigator Site 053
City
Kemerovo
ZIP/Postal Code
650029
Country
Russian Federation
Facility Name
Investigator Site 054
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Investigator Site 051
City
Moscow
Country
Russian Federation
Facility Name
Investigator Site 058
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Investigator Site 059
City
Omsk
Country
Russian Federation
Facility Name
Investigator Site 062
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Investigator Site 057
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Investigator Site 056
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Investigator Site 061
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Investigator Site 060
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Investigator Site 055
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Investigator Site 101
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Investigator Site 801
City
Colombo
Country
Sri Lanka
Facility Name
Investigator Site 804
City
Kandy
Country
Sri Lanka
Facility Name
Investigator Site 802
City
Nugegoda
Country
Sri Lanka
Facility Name
Investigator Site 452
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Investigator Site 455
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Investigator Site 454
City
Taichung
Country
Taiwan
Facility Name
Investigator Site 453
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigator Site 451
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Investigator Site 205
City
Bangkok Noi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Investigator Site 202
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Investigator Site 204
City
Muang Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Investigator Site 201
City
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
29563108
Citation
Merrill JT, Shanahan WR, Scheinberg M, Kalunian KC, Wofsy D, Martin RS. Phase III trial results with blisibimod, a selective inhibitor of B-cell activating factor, in subjects with systemic lupus erythematosus (SLE): results from a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2018 Jun;77(6):883-889. doi: 10.1136/annrheumdis-2018-213032. Epub 2018 Mar 21.
Results Reference
derived

Learn more about this trial

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

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