CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
- Registration Number
- NCT01395745
- Lead Sponsor
- Anthera Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description blisibimod weekly dose blisibimod - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of patients achieving an SLE Responder Index at week 52 Week 52
- Secondary Outcome Measures
Name Time Method Time to first severe SLE flare Week 52 Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone Week 52 Change in the number of actively tender or swollen joints and in mucocutaneous disease activity Week 52 Change in proteinuria from baseline Week 52 Safety Profile (AEs, vital signs, labs, physical exams) Week 52 Time to first renal flare Week 52 Change from baseline in B cell subsets, anti dsDNA, C3, C4 Week 52 Proportion of subjects with improved patient-reported outcomes Week 52 Time to treatment failure Week 52
Trial Locations
- Locations (90)
Investiagtor Site 513
🇮🇳Mumbai, India
Investigator Site 204
🇹🇭Muang Chiang Mai, Thailand
Investigator Site 311
🇨🇴Bogota, Colombia
Investigator Site 310
🇨🇴Atlantico, Colombia
Investigator Site 512
🇮🇳New Delhi, India
Investigator Site 304
🇨🇴Cundinamarca, Colombia
Investigator Site 508
🇮🇳Bangalore, India
Investigator Site 510
🇮🇳Pune, India
Investigator Site 602
🇧🇾Vitebsk, Belarus
Investigator Site 902
🇬🇹Guatemala, Guatemala
Investigator Site 501
🇮🇳Kolkata, India
Investigator Site 506
🇮🇳Manipal, India
Investigator Site 704
🇲🇽Mexico City, Mexico
Investigator Site 101
🇸🇬Singapore, Singapore
Investigator Site 502
🇮🇳Hyderabad, India
Investigator Site 601
🇧🇾Minsk, Belarus
Investigator Site 605
🇧🇾Minsk, Belarus
Investigator Site 302
🇨🇴Antioquia, Colombia
Investigator Site 303
🇨🇴Antioquia, Colombia
Investigator Site 703
🇲🇽Mexico City, Mexico
Investigator Site 701
🇲🇽Mexico City, Mexico
Investigator Site 402
🇵🇭Ermita, Manila, Philippines
Investigator Site 401
🇵🇭Las Pinas City, Philippines
Investigator Site 452
🇨🇳Kaohsiung City, Taiwan
Investigator Site 454
🇨🇳Taichung, Taiwan
Investigator Site 707
🇲🇽Toluca, Mexico
Investigator Site 901
🇬🇹Guatemala, Guatemala
Investigator Site 903
🇬🇹Guatemala, Guatemala
Investigator Site 511
🇮🇳New Delhi, India
Investigator Site 405
🇵🇭Davao, Philippines
Investigator Site 451
🇨🇳Taipei City, Taiwan
Investigator Site 201
🇹🇭Ratchathewi, Thailand
Investigator Site 702
🇲🇽Guanajuato, Mexico
Investigator Site 504
🇮🇳Pune, India
Investigator Site 705
🇲🇽Yucatan, Mexico
Investigator Site 406
🇵🇭Cebu City, Philippines
Investigator Site 407
🇵🇭Angeles, Philippines
Investigator Site 404
🇵🇭Cebu City, Philippines
Investigator Site 559
🇧🇷Santo Andre, Brazil
Investigator Site 604
🇧🇾Minsk, Belarus
Investigator Site 603
🇧🇾Gomel, Belarus
Investigator Site 555
🇧🇷Goiania, Brazil
Investigator Site 557
🇧🇷Juiz de Fora, Brazil
Investigator Site 554
🇧🇷Sao Paulo, Brazil
Investigator Site 301
🇨🇴Bogota, Colombia
Investigator Site 308
🇨🇴Atlantico, Colombia
Investigator Site 305
🇨🇴Santander, Colombia
Investigator Site 551
🇧🇷Porto Alegre, Brazil
Investigator Site 003
🇬🇪Tbilisi, Georgia
Investigator Site 312
🇨🇴Valle, Colombia
Investigator Site 001
🇬🇪Tbilisi, Georgia
Investigator Site 306
🇨🇴Santander, Colombia
Investigator Site 002
🇬🇪Tbilisi, Georgia
Investigator Site 355
🇰🇷Daegu, Korea, Republic of
Investigator Site 904
🇬🇹Guatemala, Guatemala
Investigator Site 505
🇮🇳Hyderabad, India
Investigator Site 353
🇰🇷Gwangju, Korea, Republic of
Investigator Site 503
🇮🇳Ahmedabad, India
Investigator Site 354
🇰🇷Suwon, Korea, Republic of
Investigator Site 252
🇲🇾Perak, Malaysia
Investigator Site 455
🇨🇳Taichung, Taiwan
Investigator Site 408
🇵🇭Cruz Manila, Philippines
Investigator Site 410
🇵🇭Iloilo City, Philippines
Investigator Site 403
🇵🇭Manila, Philippines
Investigator Site 053
🇷🇺Kemerovo, Russian Federation
Investigator Site 056
🇷🇺Saint Petersburg, Russian Federation
Investigator Site 409
🇵🇭Manila, Philippines
Investigator Site 052
🇷🇺Kemerovo, Russian Federation
Investigator Site 802
🇱🇰Nugegoda, Sri Lanka
Investigator Site 801
🇱🇰Colombo, Sri Lanka
Investigator Site 804
🇱🇰Kandy, Sri Lanka
Investigator Site 453
🇨🇳Taipei City, Taiwan
Investigator Site 351
🇰🇷Jeollabuk-do, Korea, Republic of
Investigator Site 352
🇰🇷Daejeon, Korea, Republic of
Investigator Site 152
🇭🇰Tuen Mun, Hong Kong
Investigator Site 556
🇧🇷Sao Paulo, Brazil
Investigator Site 251
🇲🇾Selangor, Malaysia
Investigator Site 051
🇷🇺Moscow, Russian Federation
Investigator Site 054
🇷🇺Kursk, Russian Federation
Investigator Site 058
🇷🇺Novosibirsk, Russian Federation
Investigator Site 055
🇷🇺Yekaterinburg, Russian Federation
Investigator Site 202
🇹🇭Khon Kaen, Thailand
Investigator Site 205
🇹🇭Bangkok Noi, Thailand
Investigator Site 059
🇷🇺Omsk, Russian Federation
Investigator Site 558
🇧🇷Curitiba, Brazil
Investigator Site 057
🇷🇺Petrozavodsk, Russian Federation
Investigator Site 062
🇷🇺Orenburg, Russian Federation
Investigator Site 060
🇷🇺Vladimir, Russian Federation
Investigator Site 061
🇷🇺Smolensk, Russian Federation
Investigator Site 151
🇭🇰Pokfulam, Hong Kong