CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT01395745
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2013-02-28
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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blisibimod weekly dose
blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
Placebo
Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks
Interventions
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blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Investigator Site 603
Homyel, , Belarus
Investigator Site 604
Minsk, , Belarus
Investigator Site 601
Minsk, , Belarus
Investigator Site 605
Minsk, , Belarus
Investigator Site 602
Vitebsk, , Belarus
Investigator Site 558
Curitiba, , Brazil
Investigator Site 555
Goiânia, , Brazil
Investigator Site 557
Juiz de Fora, , Brazil
Investigator Site 551
Porto Alegre, , Brazil
Investigator Site 559
Santo André, , Brazil
Investigator Site 554
São Paulo, , Brazil
Investigator Site 556
São Paulo, , Brazil
Investigator Site 302
Antioquia, , Colombia
Investigator Site 303
Antioquia, , Colombia
Investigator Site 308
Atlántico, , Colombia
Investigator Site 310
Atlántico, , Colombia
Investigator Site 301
Bogotá, , Colombia
Investigator Site 311
Bogotá, , Colombia
Investigator Site 304
Cundinamarca, , Colombia
Investigator Site 305
Santander, , Colombia
Investigator Site 306
Santander, , Colombia
Investigator Site 312
Valle, , Colombia
Investigator Site 001
Tbilisi, , Georgia
Investigator Site 002
Tbilisi, , Georgia
Investigator Site 003
Tbilisi, , Georgia
Investigator Site 901
Guatemala City, , Guatemala
Investigator Site 902
Guatemala City, , Guatemala
Investigator Site 903
Guatemala City, , Guatemala
Investigator Site 904
Guatemala City, , Guatemala
Investigator Site 151
Pokfulam, , Hong Kong
Investigator Site 152
Tuenmen, , Hong Kong
Investigator Site 503
Ahmedabad, , India
Investigator Site 508
Bangalore, , India
Investigator Site 505
Hyderabad, , India
Investigator Site 502
Hyderabad, , India
Investigator Site 501
Kolkata, , India
Investigator Site 506
Manipal, , India
Investiagtor Site 513
Mumbai, , India
Investigator Site 511
New Delhi, , India
Investigator Site 512
New Delhi, , India
Investigator Site 504
Pune, , India
Investigator Site 510
Pune, , India
Investigator Site 251
Kuala Selangor, , Malaysia
Investigator Site 252
Perak, , Malaysia
Investigator Site 702
Guanajuato City, , Mexico
Investigator Site 703
Mexico City, , Mexico
Investigator Site 701
Mexico City, , Mexico
Investigator Site 704
Mexico City, , Mexico
Investigator Site 707
Toluca, , Mexico
Investigator Site 705
Yucatán, , Mexico
Investigator Site 407
Angeles, , Philippines
Investigator Site 404
Cebu City, , Philippines
Investigator Site 406
Cebu City, , Philippines
Investigator Site 408
Cruz Manila, , Philippines
Investigator Site 405
Davao City, , Philippines
Investigator Site 402
Ermita, Manila, , Philippines
Investigator Site 410
Iloilo City, , Philippines
Investigator Site 401
Las Piñas, , Philippines
Investigator Site 403
Manila, , Philippines
Investigator Site 409
Manila, , Philippines
Investigator Site 052
Kemerovo, , Russia
Investigator Site 053
Kemerovo, , Russia
Investigator Site 054
Kursk, , Russia
Investigator Site 051
Moscow, , Russia
Investigator Site 058
Novosibirsk, , Russia
Investigator Site 059
Omsk, , Russia
Investigator Site 062
Orenburg, , Russia
Investigator Site 057
Petrozavodsk, , Russia
Investigator Site 056
Saint Petersburg, , Russia
Investigator Site 061
Smolensk, , Russia
Investigator Site 060
Vladimir, , Russia
Investigator Site 055
Yekaterinburg, , Russia
Investigator Site 101
Singapore, , Singapore
Investigator Site 355
Daegu, , South Korea
Investigator Site 352
Daejeon, , South Korea
Investigator Site 353
Gwangju, , South Korea
Investigator Site 351
Jeollabuk-do, , South Korea
Investigator Site 354
Suwon, , South Korea
Investigator Site 801
Colombo, , Sri Lanka
Investigator Site 804
Kandy, , Sri Lanka
Investigator Site 802
Nugegoda, , Sri Lanka
Investigator Site 452
Kaohsiung City, , Taiwan
Investigator Site 455
Taichung, , Taiwan
Investigator Site 454
Taichung, , Taiwan
Investigator Site 453
Taipei, , Taiwan
Investigator Site 451
Taipei, , Taiwan
Investigator Site 205
Bangkok Noi, , Thailand
Investigator Site 202
Khon Kaen, , Thailand
Investigator Site 204
Muang Chiang Mai, , Thailand
Investigator Site 201
Ratchathewi, , Thailand
Countries
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References
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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.
Other Identifiers
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AN-SLE3331
Identifier Type: -
Identifier Source: org_study_id
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