Systemic Lupus ErythematosusPhase 2PEARL-SCNCT01162681
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
A Phase 2 study testing A-623 in people with Systemic Lupus Erythematosus, run by Anthera Pharmaceuticals at 74 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease 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?
- Yes, some participants may receive a placebo
- How many people
- 547 participants
- Where
- 74 sitesin 11 countries
- Study dates
- Jul 2010to Apr 2012
- 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
- Diagnosis of SLE by American College of Rheumatology guidelines.
- On stable SLE treatment
- Active SLE disease
- Serologically active
- 18 years of age or older
- Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
Who cannot join
- Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
- 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.
- Malignancy within past 5 years
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
Show all 11Show fewer
- History of active tuberculosis or a history of tuberculosis infection.
- Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
- Prior administration of any B cell depleting therapy in the past 18 months.
- Pregnant or nursing
- History of congenital immunodeficiency
Trial locations and contacts
74 sites in 11 countries.
74 sites in 11 countries
United States14 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 108
Los Angeles, California, 90095
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
Brazil11 sites
Investigator Site 510
Campinas, São Paulo, 13015
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 512
Porto Alegre, Rio de Grande Do Sul, 90035-903
Investigator Site 502
Porto Alegre, Rio Grande do Sul, 9061-0000
Investigator Site 503
Rio de Janeiro, Rio de Janeiro, 21941
Investigator Site 511
Rio de Janeiro, 20551
Investigator Site 504
Salvador, Estado de Bahia, 40050-010
Investigator Site 505
São Paulo, São Paulo, 04038-004
Investigator Site 501
São Paulo, São Paulo, 04039-901
Colombia11 sites
Investigator Site 701
Barranquilla, Atlántico
Investigator Site 704
Barranquilla, Atlántico
Investigator Site 703
Bogota, Cundinamarca
Investigator Site 702
Bogotá
Investigator Site 705
Bogotá
Investigator Site 709
Bogotá
Investigator Site 707
Bucaramanga, Santander Department
Investigator Site 711
Bucaramanga
Investigator Site 706
Medellín, Antioquia
Investigator Site 710
Medellín, Antioquia
Investigator Site 708
Medellín
Mexico9 sites
Investigator Site 806
Guadalajara, Jalisco, 44280
Investigator Site 808
Guanajuato City
Inestigator Site 809
México, D.f., 14000
Investigator Site 805
México
Investigator Site 807
México
Investigator Site 803
Mexico City, D.f., 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 407
Buenos Aires, C1121ABE
Investigator Site 401
Buenos Aires, C1431FWO
Investigator Site 404
Caba, Buenos Aires, C1015ABO
Investigator Site 402
Caba, Buenos Aires, C1280AEB
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 902
Bellavista Callao, Provincia Constitucional del Callao
Investigator Site 901
Cayma, Arequipa
Investigator Site 903
Lima, Lima Province, L-01
Investigator Site 905
Lima, Lima Province, L27
Investigator Site 904
Lima, Lima Province
Chile4 sites
Investigator Site 606
Santiago, Chile
Investigator Site 602
Santiago, 8330033
Investigator Site 605
Santiago
Investigator Site 601
Viña del Mar, 2570017
India4 sites
Investigator Site 203
Bangalore, Kamataka, 560034
Investigator Site 201
Mumbai, Maharashtra, 400012
Investigator Site 205
Secunderabad, Andhra Pradesh, 500003
Investigator Site 204
Trivandrum, Kerala, 695011
Philippines4 sites
Investigator Site 302
Cebu, Cebu, 6000
Investigator Site 303
Davao City, Davao Region, 8000
Investigator Site 305
Davao City, 8000
Investigator Site 304
Manila, National Capital Region, 1008
Taiwan3 sites
Investigator Site 354
Taichung, 402
Investigator Site 352
Taichung, 414
Investigator Site 351
Taipei, 100
Hong Kong2 sites
Investigator Site 151
Hong Kong
Investigator Site 153
New Territories, Shatin
About this study
Official title: A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- A-623, Placebo Comparator
- 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.
A-623Drug
High dose given subcutaneously once a week for up to 52 weeks
A-623Drug
Low dose given subcutaneously once a week for up to 52 weeks
A-623Drug
High dose given subcutaneously once every 4 weeks for up to 52 weeks
Placebo ComparatorOther
Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| A-623 high dose weekly | Experimental | Not described Receives: Drug: A-623 |
| A-623 low dose weekly | Experimental | Not described Receives: Drug: A-623 |
| A-623 high dose every 4 weeks | Experimental | Not described Receives: Drug: A-623 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE response
The % of subjects with SLE response compared with baseline at the time of assessment
Measured: Various timepoints through Week 52
Secondary outcomes (7)
B cell reduction
Measured: Various timepoints through Week 52
Time to first flare
Measured: Various timepoints through Week 52
FACIT-fatigue score
Measured: Various timepoints through Week 52
Reduction in prednisone dose
Measured: Various timepoints through Week 52
Change in IgG, IgM,C3 and C4
Measured: Various timepoints through Week 52
Flare rates
Measured: Various timepoints through Week 52
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9
Measured: Various timepoints 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 posted15 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 547 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
- NCT01162681
- Sponsor's protocol ID
- AN-SLE3321
- Acronym
- PEARL-SC
- Status last verified
- Jan 2014
- First submitted
- 13 Jul 2010
- Last updated
- 4 Mar 2014
- 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 33687069Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, Martin RS, Scheinberg MA; PEARL-SC Study. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015 Sep;74(9):1667-75. doi: 10.1136/annrheumdis-2013-205144. Epub 2014 Apr 19.
PubMed 24748629
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01162681
- Acronym / sponsor ID
- PEARL-SC / AN-SLE3321
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Jul 2010 (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, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A-623 high dose weekly | Experimental | Drug: A-623 |
| A-623 low dose weekly | Experimental | Drug: A-623 |
| A-623 high dose every 4 weeks | Experimental | Drug: A-623 |
| Placebo | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of SLE by American College of Rheumatology guidelines.
- On stable SLE treatment
- Active SLE disease
- Serologically active
- 18 years of age or older
Key exclusion criteria (11 listed)
- Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
- 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.
- Malignancy within past 5 years
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 for up to 52 weeks | Drug | A-623 high dose weekly |
| A-623Low dose given subcutaneously once a week for up to 52 weeks | Drug | A-623 low dose weekly |
| A-623High dose given subcutaneously once every 4 weeks for up to 52 weeks | Drug | A-623 high dose every 4 weeks |
| Placebo ComparatorPlacebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks | Other | Placebo |
Primary outcome
SLE response
Time frame: Various timepoints through Week 52
The % of subjects with SLE response compared with baseline at the time of assessment
7 secondary outcomes
B cell reduction
Time frame: Various timepoints through Week 52
Time to first flare
Time frame: Various timepoints through Week 52
FACIT-fatigue score
Time frame: Various timepoints through Week 52
Reduction in prednisone dose
Time frame: Various timepoints through Week 52
Change in IgG, IgM,C3 and C4
Time frame: Various timepoints through Week 52
Flare rates
Time frame: Various timepoints through Week 52
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9
Time frame: Various timepoints through 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 4 Mar 2014.
- 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.
- Derived from this study: PubMed 24748629Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, Martin RS, Scheinberg MA; PEARL-SC Study. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015 Sep;74(9):1667-75. doi: 10.1136/annrheumdis-2013-205144. Epub 2014 Apr 19.
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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.
74 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 74 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 6 inclusion and 11 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 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. 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 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?
SLE response (time frame: Various timepoints through 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 NCT01162681, which also lists 2 linked publications.
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 4 Mar 2014.