Systemic Lupus ErythematosusPhase 3NCT00383214
Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
A Phase 3 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 60 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients 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?
- Epratuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 60 sitesin 11 countries
- Study dates
- May 2005to Mar 2007
- 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
- +ANA at screening
- BILAG Index B Level Activity in at least 2 body systems/organs
- Has SLE by ACR revised criteria (meets,<4 criteria)
Who cannot join
- Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
- Allergy to human antibodies or Murine.
Trial locations and contacts
60 sites in 11 countries.
60 sites in 11 countries
United States25 sites
Study site
Arlington, Virginia
Study site
Aventura, Florida
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Colorado Springs, Colorado
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Edmonds, Washington
Study site
Farmington, Connecticut
Study site
Gallipolis, Ohio
Study site
Los Angeles, California
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Plainview, New York
Study site
Rochester, New York
Study site
Syracuse, New York
Study site
The Bronx, New York
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Upland, California
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
United Kingdom7 sites
Study site
Birmingham
Study site
Leeds, West Yorkshire
Study site
London
Study site
Manchester
Study site
Newcastle upon Tyne
Study site
Sheffield
Study site
United Kingdom
Brazil5 sites
Study site
Goiânia
Study site
Rio de Janeiro, Rio de Janeiro
Study site
Rio de Janeiro
Study site
São Paulo
Study site
Sorocaba
Spain5 sites
Study site
Barcelona
Study site
Madrid
Study site
San Cristóbal de La Laguna
Study site
Santander
Study site
Seville
Germany4 sites
Study site
Erlangen
Study site
Heidelberg
Study site
Mannheim
Study site
München
Netherlands3 sites
Study site
Amsterdam
Study site
Groningen
Study site
Leiden
Canada2 sites
Study site
St. John's, Newfoundland and Labrador
Study site
Winnipeg, Manitoba
About this study
Official title: A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab, Placebo
- Keywords
- Lupus,, antibody,, B-cell immunotherapy
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpratuzumabDrug
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
PlaceboOther
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Epratuzumab | Active comparator | 360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion Receives: Drug: Epratuzumab |
| Placebo | Placebo comparator | Intravenous Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Secondary outcomes (8)
Proportion of patients with complete response or partial response;
Individual BILAG assessments;
Physician and patient assessment scores;
Time-to treatment failure;
Successful steroid reduction by weeks 20 and 24;
Maintenance of steroid reduction at 24 and 48 weeks;
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Assess epratuzumab on Health-related quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startMay 2005
- Primary completionMar 2007
- Study completionMar 2007
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
- Double blind
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Barry, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383214
- Sponsor's protocol ID
- SL0004(IMMU-103-04)
- Other IDs
- EudraCT #: 2005-000706-31
- Status last verified
- Jun 2012
- First submitted
- 29 Sep 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
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 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT00383214
- Acronym / sponsor ID
- SL0004(IMMU-103-04)
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus,, antibody,, B-cell immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 3 Oct 2006 (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 safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epratuzumab | Active comparator | Drug: Epratuzumab360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion |
| Placebo | Placebo comparator | Other: PlaceboIntravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- +ANA at screening
- BILAG Index B Level Activity in at least 2 body systems/organs
- Has SLE by ACR revised criteria (meets,<4 criteria)
Key exclusion criteria (2 listed)
- Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
- Allergy to human antibodies or Murine.
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 |
|---|---|---|
| Epratuzumab360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion | Drug | Epratuzumab |
| PlaceboIntravenous | Other | Placebo |
Primary outcome
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
8 secondary outcomes
Proportion of patients with complete response or partial response;
Individual BILAG assessments;
Physician and patient assessment scores;
Time-to treatment failure;
Successful steroid reduction by weeks 20 and 24;
Maintenance of steroid reduction at 24 and 48 weeks;
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Assess epratuzumab on Health-related quality of life
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- 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.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Anna Barry study director
UCB Pharma
60 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 60 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 3 inclusion and 2 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, United Kingdom, Brazil, Spain, Germany 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 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. 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?
Patient response variable (complete response, partial response, non-response) evaluated at 24 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 NCT00383214, 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 7 Jun 2012.