Systemic Lupus ErythematosusPhase 3NCT00382837
Study of Epratuzumab in Systemic Lupus Erythematosus
A Phase 3 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 54 sites in 13 countries.
Trial summary
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments 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
- How many people
- 0 participants
- Where
- 54 sitesin 13 countries
- Study dates
- Jan 2007to not given
- 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
- Must have completed SL0003 Alleviate A through 48 weeks
Who cannot join
- Development of toxicity to Epratuzumab
- Significant protocol deviations from SL0003 Study.
Trial locations and contacts
54 sites in 13 countries.
54 sites in 13 countries
United States20 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
Dallas, Texas
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
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 Kingdom6 sites
Study site
Birmingham
Study site
Leeds, West Yorkshire
Study site
London
Study site
Manchester
Study site
Newcastle upon Tyne
Study site
Sheffield
Brazil4 sites
Study site
Goiânia
Study site
Rio de Janeiro, Rio de Janeiro
Study site
Rio de Janeiro
Study site
São Paulo
Germany4 sites
Study site
Erlangen
Study site
Heidelberg
Study site
Mannheim
Study site
München
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Santander
Study site
Seville
Netherlands3 sites
Study site
Amsterdam
Study site
Groningen
Study site
Leiden
About this study
Official title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
Secondary outcomes (4)
To continue to assess the efficacy and tolerability of epratuzumab;
To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
To continue to assess epratuzumab on Health-related quality of life in lupus patients;
To continue to assess disease status as reported by the patient and physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startJan 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anna Barry, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382837
- Sponsor's protocol ID
- SL0005
- Other IDs
- EudraCT# 2006-003865-15
- Status last verified
- Mar 2007
- First submitted
- 29 Sep 2006
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems
- ClinicalTrials.gov ID
- NCT00382837
- Acronym / sponsor ID
- SL0005
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus,, Antibody,, B-Cell immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- First posted
- 2 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.
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have completed SL0003 Alleviate A through 48 weeks
Key exclusion criteria (2 listed)
- Development of toxicity to Epratuzumab
- Significant protocol deviations from SL0003 Study.
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 |
|---|---|---|
| Epratuzumab | Drug | – |
Primary outcome
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
4 secondary outcomes
To continue to assess the efficacy and tolerability of epratuzumab;
To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
To continue to assess epratuzumab on Health-related quality of life in lupus patients;
To continue to assess disease status as reported by the patient and physician.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Dapagliflozin in Active Lupus Nephritis
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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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.
Anna Barry study director
UCB Pharma
54 sites in 13 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 54 sites in 13 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 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: withdrawn, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, United Kingdom, Brazil, Germany, Spain and 8 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 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 withdrawn before enrolling participants, so there are no results.
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?
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.. 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 21 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.