Clinical trial NCT01395745: CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Lupus Erythematosus, Systemic
Autoimmune Diseases
A-623
Blisibimod
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of patients achieving an SLE Responder Index at week 52
timeFrame: Week 52
Secondary outcomes:
measure: Time to first severe SLE flare
timeFrame: Week 52
measure: Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
timeFrame: Week 52
measure: Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
timeFrame: Week 52
measure: Change in proteinuria from baseline
timeFrame: Week 52
measure: Proportion of subjects with improved patient-reported outcomes
timeFrame: Week 52
measure: Time to treatment failure
timeFrame: Week 52
measure: Time to first renal flare
timeFrame: Week 52
measure: Change from baseline in B cell subsets, anti dsDNA, C3, C4
timeFrame: Week 52
measure: Safety Profile (AEs, vital signs, labs, physical exams)
timeFrame: Week 52
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Investigator Site 603
city: Minsk
country: Belarus
facility: Investigator Site 604
city: Minsk
country: Belarus
facility: Investigator Site 601
city: Minsk
country: Belarus
facility: Investigator Site 605
city: Vitebsk
country: Belarus
facility: Investigator Site 602
city: Curitiba
country: Brazil
facility: Investigator Site 558
city: Goiania
country: Brazil
facility: Investigator Site 555
city: Juiz de Fora
country: Brazil
facility: Investigator Site 557
city: Porto Alegre
country: Brazil
facility: Investigator Site 551
city: Santo Andre
country: Brazil
facility: Investigator Site 559
city: Sao Paulo
country: Brazil
facility: Investigator Site 554
city: Sao Paulo
country: Brazil
facility: Investigator Site 556
city: Antioquia
country: Colombia
facility: Investigator Site 302
city: Antioquia
country: Colombia
facility: Investigator Site 303
city: Atlantico
country: Colombia
facility: Investigator Site 308
city: Atlantico
country: Colombia
facility: Investigator Site 310
city: Bogota
country: Colombia
facility: Investigator Site 301
city: Bogota
country: Colombia
facility: Investigator Site 311
city: Cundinamarca
country: Colombia
facility: Investigator Site 304
city: Santander
country: Colombia
facility: Investigator Site 305
city: Santander
country: Colombia
facility: Investigator Site 306
city: Valle
country: Colombia
facility: Investigator Site 312
city: Tbilisi
country: Georgia
facility: Investigator Site 001
city: Tbilisi
country: Georgia
facility: Investigator Site 002
city: Tbilisi
country: Georgia
facility: Investigator Site 003
city: Guatemala
country: Guatemala
facility: Investigator Site 901
city: Guatemala
country: Guatemala
facility: Investigator Site 902
city: Guatemala
country: Guatemala
facility: Investigator Site 903
city: Guatemala
country: Guatemala
facility: Investigator Site 904
city: Pokfulam
country: Hong Kong
facility: Investigator Site 151
city: Tuen Mun
country: Hong Kong
facility: Investigator Site 152
city: Ahmedabad
country: India
facility: Investigator Site 503
city: Bangalore
country: India
facility: Investigator Site 508
city: Hyderabad
country: India
facility: Investigator Site 505
city: Hyderabad
country: India
facility: Investigator Site 502
city: Kolkata
country: India
facility: Investigator Site 501
city: Manipal
country: India
facility: Investigator Site 506
city: Mumbai
country: India
facility: Investiagtor Site 513
city: New Delhi
country: India
facility: Investigator Site 511
city: New Delhi
country: India
facility: Investigator Site 512
city: Pune
country: India
facility: Investigator Site 504
city: Pune
country: India
facility: Investigator Site 510
city: Daegu
country: Korea, Republic of
facility: Investigator Site 355
city: Daejeon
country: Korea, Republic of
facility: Investigator Site 352
city: Gwangju
country: Korea, Republic of
facility: Investigator Site 353
city: Jeollabuk-do
country: Korea, Republic of
facility: Investigator Site 351
city: Suwon
country: Korea, Republic of
facility: Investigator Site 354
city: Perak
country: Malaysia
facility: Investigator Site 252
city: Selangor
country: Malaysia
facility: Investigator Site 251
city: Guanajuato
country: Mexico
facility: Investigator Site 702
city: Mexico City
country: Mexico
facility: Investigator Site 703
city: Mexico City
country: Mexico
facility: Investigator Site 701
city: Mexico City
country: Mexico
facility: Investigator Site 704
city: Toluca
country: Mexico
facility: Investigator Site 707
city: Yucatan
country: Mexico
facility: Investigator Site 705
city: Angeles
country: Philippines
facility: Investigator Site 407
city: Cebu City
country: Philippines
facility: Investigator Site 404
city: Cebu City
country: Philippines
facility: Investigator Site 406
city: Cruz Manila
country: Philippines
facility: Investigator Site 408
city: Davao
country: Philippines
facility: Investigator Site 405
city: Ermita, Manila
country: Philippines
facility: Investigator Site 402
city: Iloilo City
country: Philippines
facility: Investigator Site 410
city: Las Pinas City
country: Philippines
facility: Investigator Site 401
city: Manila
country: Philippines
facility: Investigator Site 403
city: Manila
country: Philippines
facility: Investigator Site 409
city: Kemerovo
country: Russian Federation
facility: Investigator Site 052
city: Kemerovo
country: Russian Federation
facility: Investigator Site 053
city: Kursk
country: Russian Federation
facility: Investigator Site 054
city: Moscow
country: Russian Federation
facility: Investigator Site 051
city: Novosibirsk
country: Russian Federation
facility: Investigator Site 058
city: Omsk
country: Russian Federation
facility: Investigator Site 059
city: Orenburg
country: Russian Federation
facility: Investigator Site 062
city: Petrozavodsk
country: Russian Federation
facility: Investigator Site 057
city: Saint Petersburg
country: Russian Federation
facility: Investigator Site 056
city: Smolensk
country: Russian Federation
facility: Investigator Site 061
city: Vladimir
country: Russian Federation
facility: Investigator Site 060
city: Yekaterinburg
country: Russian Federation
facility: Investigator Site 055
city: Singapore
country: Singapore
facility: Investigator Site 101
city: Colombo
country: Sri Lanka
facility: Investigator Site 801
city: Kandy
country: Sri Lanka
facility: Investigator Site 804
city: Nugegoda
country: Sri Lanka
facility: Investigator Site 802
city: Kaohsiung City
country: Taiwan
facility: Investigator Site 452
city: Taichung
country: Taiwan
facility: Investigator Site 455
city: Taichung
country: Taiwan
facility: Investigator Site 454
city: Taipei City
country: Taiwan
facility: Investigator Site 453
city: Taipei City
country: Taiwan
facility: Investigator Site 451
city: Bangkok Noi
country: Thailand
facility: Investigator Site 205
city: Khon Kaen
country: Thailand
facility: Investigator Site 202
city: Muang Chiang Mai
country: Thailand
facility: Investigator Site 204
city: Ratchathewi
country: Thailand
facility: Investigator Site 201
Study officials:
References:
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.