CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Systemic Lupus Erythematosus Clinical Trial

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 With or Without Nephritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02074020
• Other study ID #: AN-SLE3332
• Status: Withdrawn
• Phase: Phase 3
• First received: February 26, 2014
• Last updated: August 11, 2015
• Start date: December 2015

Study information

• Verified date: August 2015
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• 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

• Subjects with stable nephritis may be enrolled

• 18 years of age or older

Exclusion Criteria:

• Severe active vasculitis, active central nervous system lupus, 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Drug:
• Blisibimod
Administered via subcutaneous injection once per week
• Placebo
Administered via subcutaneous injection once per week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline		52 Weeks	No
Primary	Proportion of responders to the SRI-8 composite responder index		52 Weeks	No
Secondary	Time to first severe SLE flare		Baseline through 52 weeks	No
Secondary	Change in the number of actively tender or swollen joints and in mucocutaneous disease activity		52 Weeks	No
Secondary	Change in proteinuria from baseline		Week 52	No
Secondary	Proportion of subjects able to reduce oral steroid dose		Baseline through 52 weeks	No
Secondary	Proportion of subjects with improved patient-reported outcomes		Week 52	No
Secondary	Time to treatment failure		Through week 52	No
Secondary	Change from baseline in B cell subsets, anti-dsDNA, C3, C4		Through week 52	No
Secondary	Safety profile (AEs, vital signs, labs, physical exams)		Through week 52	Yes