NCT02514967

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

July 31, 2015

Last Update Submit

May 19, 2017

Conditions

Systemic Lupus Erythematosus

Keywords

SLELupusLupus Erythematosus, SystemicAutoimmune DiseasesA-623BlisibimodNephritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of responders to the SRI-6 composite responder index

    52 Weeks

Secondary Outcomes (8)

  • Time to first severe SLE flare

    Baseline through 52 weeks

  • Change in the number of actively tender or swollen joints and in mucocutaneous disease activity

    52 Weeks

  • Change in proteinuria from baseline

    Week 52

  • Proportion of subjects able to reduce oral steroid dose to ≤ 7.5 mg

    Baseline through 52 weeks

  • Proportion of subjects with improved patient-reported outcomes

    Week 52

  • +3 more secondary outcomes

Other Outcomes (1)

  • Occurrence of renal flare in subjects with renal manifestations at baseline

    52 Weeks

Study Arms (2)

Blisibimod

EXPERIMENTAL
Drug: Blisibimod

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BlisibimodDRUG

Administered via subcutaneous injection once per week

Blisibimod
PlaceboDRUG

Administered via subcutaneous injection once per week

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Investigator Site 004

Tbilisi, 0102, Georgia

Location

Investigator Site 001

Tbilisi, 0179, Georgia

Location

Investigator Site 002

Tbilisi, 0186, Georgia

Location

Related Publications (1)

  • 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.

    PMID: 33687069DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune DiseasesNephritis

Interventions

AMG623 peptibody

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital 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 31, 2015

First Posted

August 4, 2015

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 28, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

GE(3)