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

Systemic Lupus Erythematosus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395745
• Other study ID #: AN-SLE3331
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: February 2, 2017
• Start date: February 2013
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
• Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks

Locations

Country	Name	City	State
Belarus	Investigator Site 603	Gomel
Belarus	Investigator Site 601	Minsk
Belarus	Investigator Site 604	Minsk
Belarus	Investigator Site 605	Minsk
Belarus	Investigator Site 602	Vitebsk
Brazil	Investigator Site 558	Curitiba
Brazil	Investigator Site 555	Goiania
Brazil	Investigator Site 557	Juiz de Fora
Brazil	Investigator Site 551	Porto Alegre
Brazil	Investigator Site 559	Santo Andre
Brazil	Investigator Site 554	Sao Paulo
Brazil	Investigator Site 556	Sao Paulo
Colombia	Investigator Site 302	Antioquia
Colombia	Investigator Site 303	Antioquia
Colombia	Investigator Site 308	Atlantico
Colombia	Investigator Site 310	Atlantico
Colombia	Investigator Site 301	Bogota
Colombia	Investigator Site 311	Bogota
Colombia	Investigator Site 304	Cundinamarca
Colombia	Investigator Site 305	Santander
Colombia	Investigator Site 306	Santander
Colombia	Investigator Site 312	Valle
Georgia	Investigator Site 001	Tbilisi
Georgia	Investigator Site 002	Tbilisi
Georgia	Investigator Site 003	Tbilisi
Guatemala	Investigator Site 901	Guatemala
Guatemala	Investigator Site 902	Guatemala
Guatemala	Investigator Site 903	Guatemala
Guatemala	Investigator Site 904	Guatemala
Hong Kong	Investigator Site 151	Pokfulam
Hong Kong	Investigator Site 152	Tuen Mun
India	Investigator Site 503	Ahmedabad
India	Investigator Site 508	Bangalore
India	Investigator Site 502	Hyderabad
India	Investigator Site 505	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
Korea, Republic of	Investigator Site 355	Daegu
Korea, Republic of	Investigator Site 352	Daejeon
Korea, Republic of	Investigator Site 353	Gwangju
Korea, Republic of	Investigator Site 351	Jeollabuk-do
Korea, Republic of	Investigator Site 354	Suwon
Malaysia	Investigator Site 252	Perak
Malaysia	Investigator Site 251	Selangor
Mexico	Investigator Site 702	Guanajuato
Mexico	Investigator Site 701	Mexico City
Mexico	Investigator Site 703	Mexico City
Mexico	Investigator Site 704	Mexico City
Mexico	Investigator Site 707	Toluca
Mexico	Investigator Site 705	Yucatan
Philippines	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
Philippines	Investigator Site 402	Ermita, Manila
Philippines	Investigator Site 410	Iloilo City
Philippines	Investigator Site 401	Las Pinas City
Philippines	Investigator Site 403	Manila
Philippines	Investigator Site 409	Manila
Russian Federation	Investigator Site 052	Kemerovo
Russian Federation	Investigator Site 053	Kemerovo
Russian Federation	Investigator Site 054	Kursk
Russian Federation	Investigator Site 051	Moscow
Russian Federation	Investigator Site 058	Novosibirsk
Russian Federation	Investigator Site 059	Omsk
Russian Federation	Investigator Site 062	Orenburg
Russian Federation	Investigator Site 057	Petrozavodsk
Russian Federation	Investigator Site 056	Saint Petersburg
Russian Federation	Investigator Site 061	Smolensk
Russian Federation	Investigator Site 060	Vladimir
Russian Federation	Investigator Site 055	Yekaterinburg
Singapore	Investigator Site 101	Singapore
Sri Lanka	Investigator Site 801	Colombo
Sri Lanka	Investigator Site 804	Kandy
Sri Lanka	Investigator Site 802	Nugegoda
Taiwan	Investigator Site 452	Kaohsiung City
Taiwan	Investigator Site 454	Taichung
Taiwan	Investigator Site 455	Taichung
Taiwan	Investigator Site 451	Taipei City
Taiwan	Investigator Site 453	Taipei City
Thailand	Investigator Site 205	Bangkok Noi
Thailand	Investigator Site 202	Khon Kaen
Thailand	Investigator Site 204	Muang Chiang Mai
Thailand	Investigator Site 201	Ratchathewi

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

Belarus,  Brazil,  Colombia,  Georgia,  Guatemala,  Hong Kong,  India,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  Russian Federation,  Singapore,  Sri Lanka,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving an SLE Responder Index at week 52		Week 52
Secondary	Time to first severe SLE flare		Week 52
Secondary	Proportion of subjects able to reduce oral steroid dose to =7.5 mg/day prednisone		Week 52
Secondary	Change in the number of actively tender or swollen joints and in mucocutaneous disease activity		Week 52
Secondary	Change in proteinuria from baseline		Week 52
Secondary	Proportion of subjects with improved patient-reported outcomes		Week 52
Secondary	Time to treatment failure		Week 52
Secondary	Time to first renal flare		Week 52
Secondary	Change from baseline in B cell subsets, anti dsDNA, C3, C4		Week 52
Secondary	Safety Profile (AEs, vital signs, labs, physical exams)		Week 52