Systemic Lupus ErythematosusPhase 3CHABLIS-SC1NCT01395745
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
A Phase 3 study testing blisibimod in people with Systemic Lupus Erythematosus, run by Anthera Pharmaceuticals at 90 sites in 16 countries.
Trial 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. 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
- 442 participants
- Where
- 90 sitesin 16 countries
- Study dates
- Feb 2013to Oct 2016
- 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
- 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
- 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
90 sites in 16 countries.
90 sites in 16 countries
Russia12 sites
Investigator Site 052
Kemerovo, 650000
Investigator Site 053
Kemerovo, 650029
Investigator Site 054
Kursk, 305007
Investigator Site 051
Moscow
Investigator Site 058
Novosibirsk, 630091
Investigator Site 059
Omsk
Investigator Site 062
Orenburg, 460000
Investigator Site 057
Petrozavodsk, 185019
Investigator Site 056
Saint Petersburg, 192242
Investigator Site 061
Smolensk, 214025
Investigator Site 060
Vladimir, 600023
Investigator Site 055
Yekaterinburg, 620102
India11 sites
Investigator Site 503
Ahmedabad, 382428
Investigator Site 508
Bangalore, 560034
Investigator Site 505
Hyderabad, 500 082
Investigator Site 502
Hyderabad, 500 096
Investigator Site 501
Kolkata, 700054
Investigator Site 506
Manipal, 576 104
Investiagtor Site 513
Mumbai, 400053
Investigator Site 511
New Delhi, 110 060
Investigator Site 512
New Delhi, 110 076
Investigator Site 504
Pune, 411 001
Investigator Site 510
Pune, 411007
Colombia10 sites
Investigator Site 302
Antioquia
Investigator Site 303
Antioquia
Investigator Site 308
Atlántico
Investigator Site 310
Atlántico
Investigator Site 301
Bogotá
Investigator Site 311
Bogotá
Investigator Site 304
Cundinamarca
Investigator Site 305
Santander
Investigator Site 306
Santander
Investigator Site 312
Valle
Philippines10 sites
Investigator Site 407
Angeles, 2009
Investigator Site 404
Cebu City, 6000
Investigator Site 406
Cebu City, 6000
Investigator Site 408
Cruz Manila, 1003
Investigator Site 405
Davao City, 8000
Investigator Site 402
Ermita, Manila, 1000
Investigator Site 410
Iloilo City, 5000
Investigator Site 401
Las Piñas, 1742
Investigator Site 403
Manila, 1008
Investigator Site 409
Manila
Brazil7 sites
Investigator Site 558
Curitiba
Investigator Site 555
Goiânia, 74110-120
Investigator Site 557
Juiz de Fora, 36010-570
Investigator Site 551
Porto Alegre, 90610-000
Investigator Site 559
Santo André
Investigator Site 554
São Paulo, 04032-060
Investigator Site 556
São Paulo, 13015-001
Mexico6 sites
Investigator Site 702
Guanajuato City, 37000
Investigator Site 703
Mexico City, 07760
Investigator Site 701
Mexico City, 14000
Investigator Site 704
Mexico City, 97133
Investigator Site 707
Toluca, 50120
Investigator Site 705
Yucatán, 97133
Belarus5 sites
Investigator Site 603
Homyel, 246029
Investigator Site 604
Minsk, 220037
Investigator Site 601
Minsk, 220116
Investigator Site 605
Minsk, 223040
Investigator Site 602
Vitebsk, 210037
South Korea5 sites
Investigator Site 355
Daegu
Investigator Site 352
Daejeon, 301-721
Investigator Site 353
Gwangju, 501-757
Investigator Site 351
Jeollabuk-do, 561-712
Investigator Site 354
Suwon, 443-721
Taiwan5 sites
Investigator Site 452
Kaohsiung City, 83301
Investigator Site 455
Taichung, 40447
Investigator Site 454
Taichung
Investigator Site 453
Taipei, 100
Investigator Site 451
Taipei, 110
Guatemala4 sites
Investigator Site 901
Guatemala City, 01010
Investigator Site 902
Guatemala City, 01011
Investigator Site 903
Guatemala City
Investigator Site 904
Guatemala City
Thailand4 sites
Investigator Site 205
Bangkok Noi, 10700
Investigator Site 202
Khon Kaen, 40002
Investigator Site 204
Muang Chiang Mai, 50200
Investigator Site 201
Ratchathewi, 10400
Georgia3 sites
Investigator Site 001
Tbilisi, 0102
Investigator Site 002
Tbilisi, 0186
Investigator Site 003
Tbilisi, 0186
Sri Lanka3 sites
Investigator Site 801
Colombo
Investigator Site 804
Kandy
Investigator Site 802
Nugegoda
Hong Kong2 sites
Investigator Site 151
Pokfulam
Investigator Site 152
Tuenmen
Malaysia2 sites
Investigator Site 251
Kuala Selangor
Investigator Site 252
Perak
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
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
- Being tested
- blisibimod, Placebo
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blisibimodDrug
blisibimod administered via subcutaneous injection every week for 52 weeks
PlaceboDrug
Placebo will be administered weekly via subcutaneous injection for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| blisibimod weekly dose | 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 patients achieving an SLE Responder Index at week 52
Measured: Week 52
Secondary outcomes (9)
Time to first severe SLE flare
Measured: Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
Measured: Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Measured: Week 52
Change in proteinuria from baseline
Measured: Week 52
Proportion of subjects with improved patient-reported outcomes
Measured: Week 52
Time to treatment failure
Measured: Week 52
Time to first renal flare
Measured: Week 52
Change from baseline in B cell subsets, anti dsDNA, C3, C4
Measured: Week 52
Safety Profile (AEs, vital signs, labs, physical exams)
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startFeb 2013
- Primary completionJul 2016
- Study completionOct 2016
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
- 442 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
- NCT01395745
- Sponsor's protocol ID
- AN-SLE3331
- Acronym
- CHABLIS-SC1
- Status last verified
- Aug 2016
- First submitted
- 14 Jul 2011
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29563108
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 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
- ClinicalTrials.gov ID
- NCT01395745
- Acronym / sponsor ID
- CHABLIS-SC1 / AN-SLE3331
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Jul 2011 (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 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.
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 weekly dose | 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 (4 listed)
- 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
- 18 years of age or older
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| blisibimodblisibimod administered via subcutaneous injection every week for 52 weeks | Drug | blisibimod weekly dose |
| PlaceboPlacebo will be administered weekly via subcutaneous injection for 52 weeks | Drug | Placebo |
Primary outcome
Proportion of patients achieving an SLE Responder Index at week 52
Time frame: Week 52
9 secondary outcomes
Time to first severe SLE flare
Time frame: Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
Time frame: Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Time frame: Week 52
Change in proteinuria from baseline
Time frame: Week 52
Proportion of subjects with improved patient-reported outcomes
Time frame: Week 52
Time to treatment failure
Time frame: Week 52
Time to first renal flare
Time frame: Week 52
Change from baseline in B cell subsets, anti dsDNA, C3, C4
Time frame: Week 52
Safety Profile (AEs, vital signs, labs, physical exams)
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 29563108Merrill 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.
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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.
90 sites in 16 countries: 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 90 sites in 16 countries.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in Russia, India, Colombia, Philippines, Brazil and 11 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients achieving an SLE Responder Index at week 52 (time frame: Week 52). 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 NCT01395745, 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 3 Feb 2017.