CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

NCT ID: NCT02514967

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-02-28

Brief 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 seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or C4).

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Blisibimod

Group Type: EXPERIMENTAL

Blisibimod

Intervention Type: DRUG

Administered via subcutaneous injection once per week

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered via subcutaneous injection once per week

Interventions

Blisibimod

Administered via subcutaneous injection once per week

Intervention Type: DRUG

Placebo

Administered via subcutaneous injection once per week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
• Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
• Positive for anti-double stranded DNA (anti-dsDNA) and low complement
• Subjects with stable nephritis may be enrolled
• 18 years of age or older

Exclusion Criteria

• Severe active central nervous system lupus
• Malignancy within past 5 years
• Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
• Comorbidities that would interfere with evaluations of study drug effect
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthera Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigator Site 004

Tbilisi, , Georgia

Investigator Site 001

Tbilisi, , Georgia

Investigator Site 002

Tbilisi, , Georgia

Countries

Georgia

References

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Reference Type: DERIVED

PMID: 33687069 (View on PubMed)

Other Identifiers

AN-SLE3343

Identifier Type: -

Identifier Source: org_study_id