Systemic Lupus ErythematosusPhase 2NCT01305746
A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
A Phase 2 study testing A-623 in people with Systemic Lupus Erythematosus, run by Anthera Pharmaceuticals at 71 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE. 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?
- A-623
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 71 sitesin 11 countries
- Study dates
- Apr 2011to Oct 2013
- Phase
- Phase 2
- 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
- Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
Who cannot join
- Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
- Pregnant or nursing
- Any prior administration of a B-cell modulating therapy other than A-623
- Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
Trial locations and contacts
71 sites in 11 countries.
71 sites in 11 countries
United States13 sites
Investigator Site 117
Baltimore, Maryland, 21205
Investigator Site 103
Birmingham, Alabama, 35294
Investigator Site 101
Greenville, North Carolina, 27834
Investigator Site 115
Houston, Texas, 77034
Investigator Site 106
Lake Success, New York, 11042
Investigator Site 104
Lansing, Michigan, 48910
Investigator Site 113
Long Beach, California, 90806
Investigator Site 112
Oklahoma City, Oklahoma, 73104
Investigator Site 105
Orlando, Florida, 32806
Investigator Site 114
Smithtown, New York, 11787
Investigator Site 102
Tampa, Florida, 33614
Investigator Site 111
Tulsa, Oklahoma, 74104
Investigator Site 110
Upland, California, 91786
Brazil10 sites
Investigator Site 507
Goiânia, Goiás, 74110120
Investigator Site 509
Goiás, Goiania, 74605-050
Investigator Site 506
Juiz de Fora, Minas Gerais, 36010-570
Investigator Site 502
Porto Alegre, Rio Grande do Sul, 9061-0000
Investigator Site 511
Rio de Janeiro, Rio de Janeiro, 20551-030
Investigator Site 503
Rio de Janeiro, Rio de Janeiro, 21941-913
Investigator Site 504
Salvador, Estado de Bahia, 40050-010
Investigator 505
São Paulo, São Paulo, 04038-004
Investigator Site 501
São Paulo, São Paulo, 04039-901
Investigator Site 510
São Paulo, 13015-001
Colombia10 sites
Investigator Site 701
Barranquilla, Atlántico
Investigator Site 704
Barranquilla, Atlántico
Investigator Site 705
Bogota, Cundinamarca, 01
Investigator Site 702
Bogota, Cundinamarca
Investigator Site 709
Bogota, Cundinamarca
Investigator Site 707
Bucaramanga, Santander Department
Investigator Site 711
Bucaramanga, Santander Department
Investigator Site 706
Medellín, Antioquia
Investigator Site 708
Medellín, Antioquia
Investigator Site 710
Medellín, Antioquia
Mexico9 sites
Investigator Site 806
Guadalajara, Jalisco, 44280
Investigator Site 808
León, Guanajuato, 37320
Investigator Site 805
México, D.f., 07760
Investigator Site 807
México, D.f., 6726
Investigator Site 809
Mexico City, C.p., 14000
Investigator Site 803
Mexico City, Mexico City, 06726
Investigator Site 804
Morelia, Michoacán, 58070
Investigator Site 801
San Luis Potosí City, San Luis Potosí, 78240
Investigator Site 802
Toluca, State of Mexico, 50120
Argentina7 sites
Investigator Site 404
Caba, Buenos Aires, C1015ABO
Investigator Site 402
Caba, Buenos Aires, C1280AEB
Investigator Site 407
Caba, Buenos Aires, C1425DTG
Investigator Site 401
Caba, Buenos Aires, C1431FWO
Investigator Site 403
Rosario, Santa Fe Province, S2000PBJ
Investigator Site 408
San Juan, San Juan Province, 5400
Investigator Site 406
San Miguel de Tucumán, Tucumán Province, T4000AXL
Peru5 sites
Investigator Site 901
Arequipa
Investigator Site 902
Callao
Investigator Site 903
Lima, Lima Province, L-01
Investigator Site 904
Lima, Lima Province, L-01
Investigator Site 905
Lima, Lima Province
Chile4 sites
Investigator Site 606
Santiago, RM, 7510186
Investigator Site 605
Santiago, Santiago Metropolitan
Investigator Site 602
Santiago, 8330033
Investigator Site 601
Viña del Mar, 2570017
India4 sites
Investigator Site 203
Bangalore, Karnataka, 560034
Investigator Site 205
Hyderabad, Andhra Pradesh, 500 003
Investigator Site 201
Mumbai, Maharashtra, 400012
Investigator Site 204
Trivandrum, Kerala, 695011
Philippines4 sites
Investigator Site 302
Cebu City, Cebu, 6000
Investigator Site 303
Davao City, Davao Region, 8000
Investigator Site 305
Davao City, Davao Region, 8000
Investigator Site 304
Manila, National Capital Region, 1008
Taiwan3 sites
Investigator Site 352
Dawan, Taichung, 404
Investigator Site 354
Taichung, 402
Investigator Site 351
Taiwan, Taipei, 100
Hong Kong2 sites
Investigator Site 151
Hong Kong
Investigator Site 153
New Territories, Shatin
About this study
Official title: An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- A-623
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, A-623, Autoimmune Diseases, 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.
A-623Drug
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
A-623Drug
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
A-623Drug
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
| Study group | Role | What they receive |
|---|---|---|
| A-623 high dose weekly | Experimental | High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study Receives: Drug: A-623 |
| A-623 low dose weekly | Experimental | Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study Receives: Drug: A-623 |
| A-623 high dose every 4 weeks | Experimental | High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study Receives: Drug: A-623 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the long term safety of A-623 in subjects with SLE
Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths
Measured: Until the drug is approved or the Sponsor discontinues the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 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
- NCT01305746
- Sponsor's protocol ID
- AN-SLE3322
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2011
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
- ClinicalTrials.gov ID
- NCT01305746
- Acronym / sponsor ID
- AN-SLE3322
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, A-623, Autoimmune Diseases, Blisibimod
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Mar 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 long-term safety of A-623 in subjects with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A-623 high dose weekly | Experimental | Drug: A-623High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
| A-623 low dose weekly | Experimental | Drug: A-623Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
| A-623 high dose every 4 weeks | Experimental | Drug: A-623High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
Key exclusion criteria (4 listed)
- Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
- Pregnant or nursing
- Any prior administration of a B-cell modulating therapy other than A-623
- Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
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 |
|---|---|---|
| A-623High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study | Drug | A-623 high dose weekly |
| A-623Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study | Drug | A-623 low dose weekly |
| A-623High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study | Drug | A-623 high dose every 4 weeks |
Primary outcome
To assess the long term safety of A-623 in subjects with SLE
Time frame: Until the drug is approved or the Sponsor discontinues the study
Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths
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 13 Feb 2014.
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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.
71 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A-623 in people with Systemic Lupus Erythematosus, run by Anthera Pharmaceuticals at 71 sites in 11 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 1 inclusion and 4 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Brazil, Colombia, Mexico, Argentina and 6 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the long term safety of A-623 in subjects with SLE (time frame: Until the drug is approved or the Sponsor discontinues the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2014.