Systemic Lupus ErythematosusPhase 3NCT02514967
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
A Phase 3 study testing Blisibimod in people with Systemic Lupus Erythematosus, run by Anthera Pharmaceuticals at 3 sites in Georgia.
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 seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Blisibimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 3 sitesGeorgia
- Study dates
- Jun 2016to 28 Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Georgia3 sites
Investigator Site 004
Tbilisi, 0102
Investigator Site 001
Tbilisi, 0179
Investigator Site 002
Tbilisi, 0186
About this study
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
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
- Being tested
- Blisibimod, Placebo
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod, Nephritis
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlisibimodDrug
Administered via subcutaneous injection once per week
PlaceboDrug
Administered via subcutaneous injection once per week
| Study group | Role | What they receive |
|---|---|---|
| Blisibimod | Experimental | Not described Receives: Drug: Blisibimod |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders to the SRI-6 composite responder index
Measured: 52 Weeks
Secondary outcomes (8)
Time to first severe SLE flare
Measured: Baseline through 52 weeks
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Measured: 52 Weeks
Change in proteinuria from baseline
Measured: Week 52
Proportion of subjects able to reduce oral steroid dose to ≤ 7.5 mg
Measured: Baseline through 52 weeks
Proportion of subjects with improved patient-reported outcomes
Measured: Week 52
Time to treatment failure
Measured: Through week 52
Change from baseline in B cell counts, anti-dsDNA, C3, C4
Measured: Through week 52
Number of adverse events
Measured: Through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completion28 Feb 2017
Why it stopped: Study halted prematurely and will not resume. Subjects were seen until February 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514967
- Sponsor's protocol ID
- AN-SLE3343
- Status last verified
- May 2017
- First submitted
- 31 Jul 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33687069
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02514967
- Acronym / sponsor ID
- AN-SLE3343
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod, Nephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume. Subjects were seen until February 2017
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blisibimod | Experimental | Drug: Blisibimod |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlisibimodAdministered via subcutaneous injection once per week | Drug | Blisibimod |
| PlaceboAdministered via subcutaneous injection once per week | Drug | Placebo |
Primary outcome
Proportion of responders to the SRI-6 composite responder index
Time frame: 52 Weeks
8 secondary outcomes
Time to first severe SLE flare
Time frame: Baseline through 52 weeks
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Time frame: 52 Weeks
Change in proteinuria from baseline
Time frame: Week 52
Proportion of subjects able to reduce oral steroid dose to ≤ 7.5 mg
Time frame: Baseline through 52 weeks
Proportion of subjects with improved patient-reported outcomes
Time frame: Week 52
Time to treatment failure
Time frame: Through week 52
Change from baseline in B cell counts, anti-dsDNA, C3, C4
Time frame: Through week 52
Number of adverse events
Time frame: Through week 52
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume. Subjects were seen until February 2017). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 33687069Hannon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blisibimod in people with Systemic Lupus Erythematosus, run by Anthera Pharmaceuticals at 3 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume. Subjects were seen until February 2017). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders to the SRI-6 composite responder index (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.