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

NCT01395745 | Completed Phase 3 DMC

• 1 other identifier: AN-SLE3331
• Study Type: interventional
• Target: 442
• Locations: 16 countries
• Sites: 90

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Lupus; Lupus Erythematosus, Systemic; Autoimmune Diseases; A-623; Blisibimod

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving an SLE Responder Index at week 52

  Week 52

Secondary Outcomes (9)

• 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

• Proportion of subjects with improved patient-reported outcomes

  Week 52

Study Arms (2)

blisibimod weekly dose

EXPERIMENTAL

Drug: blisibimod

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

blisibimod DRUG

blisibimod administered via subcutaneous injection every week for 52 weeks

blisibimod weekly dose

Placebo DRUG

Placebo will be administered weekly via subcutaneous injection for 52 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (90)

Investigator Site 603

Homyel, 246029, Belarus

Location

Investigator Site 604

Minsk, 220037, Belarus

Location

Investigator Site 601

Minsk, 220116, Belarus

Location

Investigator Site 605

Minsk, 223040, Belarus

Location

Investigator Site 602

Vitebsk, 210037, Belarus

Location

Investigator Site 558

Curitiba, Brazil

Location

Investigator Site 555

Goiânia, 74110-120, Brazil

Location

Investigator Site 557

Juiz de Fora, 36010-570, Brazil

Location

Investigator Site 551

Porto Alegre, 90610-000, Brazil

Location

Investigator Site 559

Santo André, Brazil

Location

Investigator Site 554

São Paulo, 04032-060, Brazil

Location

Investigator Site 556

São Paulo, 13015-001, Brazil

Location

Investigator Site 302

Antioquia, Colombia

Location

Investigator Site 303

Antioquia, Colombia

Location

Investigator Site 308

Atlántico, Colombia

Location

Investigator Site 310

Atlántico, Colombia

Location

Investigator Site 301

Bogotá, Colombia

Location

Investigator Site 311

Bogotá, Colombia

Location

Investigator Site 304

Cundinamarca, Colombia

Location

Investigator Site 305

Santander, Colombia

Location

Investigator Site 306

Santander, Colombia

Location

Investigator Site 312

Valle, Colombia

Location

Investigator Site 001

Tbilisi, 0102, Georgia

Location

Investigator Site 002

Tbilisi, 0186, Georgia

Location

Investigator Site 003

Tbilisi, 0186, Georgia

Location

Investigator Site 901

Guatemala City, 01010, Guatemala

Location

Investigator Site 902

Guatemala City, 01011, Guatemala

Location

Investigator Site 903

Guatemala City, Guatemala

Location

Investigator Site 904

Guatemala City, Guatemala

Location

Investigator Site 151

Pokfulam, Hong Kong

Location

Investigator Site 152

Tuenmen, Hong Kong

Location

Investigator Site 503

Ahmedabad, 382428, India

Location

Investigator Site 508

Bangalore, 560034, India

Location

Investigator Site 505

Hyderabad, 500 082, India

Location

Investigator Site 502

Hyderabad, 500 096, India

Location

Investigator Site 501

Kolkata, 700054, India

Location

Investigator Site 506

Manipal, 576 104, India

Location

Investiagtor Site 513

Mumbai, 400053, India

Location

Investigator Site 511

New Delhi, 110 060, India

Location

Investigator Site 512

New Delhi, 110 076, India

Location

Investigator Site 504

Pune, 411 001, India

Location

Investigator Site 510

Pune, 411007, India

Location

Investigator Site 251

Kuala Selangor, Malaysia

Location

Investigator Site 252

Perak, Malaysia

Location

Investigator Site 702

Guanajuato City, 37000, Mexico

Location

Investigator Site 703

Mexico City, 07760, Mexico

Location

Investigator Site 701

Mexico City, 14000, Mexico

Location

Investigator Site 704

Mexico City, 97133, Mexico

Location

Investigator Site 707

Toluca, 50120, Mexico

Location

Investigator Site 705

Yucatán, 97133, Mexico

Location

Investigator Site 407

Angeles, 2009, Philippines

Location

Investigator Site 404

Cebu City, 6000, Philippines

Location

Investigator Site 406

Cebu City, 6000, Philippines

Location

Investigator Site 408

Cruz Manila, 1003, Philippines

Location

Investigator Site 405

Davao City, 8000, Philippines

Location

Investigator Site 402

Ermita, Manila, 1000, Philippines

Location

Investigator Site 410

Iloilo City, 5000, Philippines

Location

Investigator Site 401

Las Piñas, 1742, Philippines

Location

Investigator Site 403

Manila, 1008, Philippines

Location

Investigator Site 409

Manila, Philippines

Location

Investigator Site 052

Kemerovo, 650000, Russia

Location

Investigator Site 053

Kemerovo, 650029, Russia

Location

Investigator Site 054

Kursk, 305007, Russia

Location

Investigator Site 051

Moscow, Russia

Location

Investigator Site 058

Novosibirsk, 630091, Russia

Location

Investigator Site 059

Omsk, Russia

Location

Investigator Site 062

Orenburg, 460000, Russia

Location

Investigator Site 057

Petrozavodsk, 185019, Russia

Location

Investigator Site 056

Saint Petersburg, 192242, Russia

Location

Investigator Site 061

Smolensk, 214025, Russia

Location

Investigator Site 060

Vladimir, 600023, Russia

Location

Investigator Site 055

Yekaterinburg, 620102, Russia

Location

Investigator Site 101

Singapore, 119228, Singapore

Location

Investigator Site 355

Daegu, South Korea

Location

Investigator Site 352

Daejeon, 301-721, South Korea

Location

Investigator Site 353

Gwangju, 501-757, South Korea

Location

Investigator Site 351

Jeollabuk-do, 561-712, South Korea

Location

Investigator Site 354

Suwon, 443-721, South Korea

Location

Investigator Site 801

Colombo, Sri Lanka

Location

Investigator Site 804

Kandy, Sri Lanka

Location

Investigator Site 802

Nugegoda, Sri Lanka

Location

Investigator Site 452

Kaohsiung City, 83301, Taiwan

Location

Investigator Site 455

Taichung, 40447, Taiwan

Location

Investigator Site 454

Taichung, Taiwan

Location

Investigator Site 453

Taipei, 100, Taiwan

Location

Investigator Site 451

Taipei, 110, Taiwan

Location

Investigator Site 205

Bangkok Noi, 10700, Thailand

Location

Investigator Site 202

Khon Kaen, 40002, Thailand

Location

Investigator Site 204

Muang Chiang Mai, 50200, Thailand

Location

Investigator Site 201

Ratchathewi, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 29563108 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Interventions

AMG623 peptibody

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: February 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2016-08

Locations

TW (5); SG (1); CO (10); MY (2); GE (3); RU (12); BE (5); TH (4); BR (7); PH (10); ME (6); KR (5); SR (3); IN (11); HK (2); GU (4)