Systemic Lupus ErythematosusPhase 3NCT00111306
Study of Epratuzumab in Systemic Lupus Erythematosus
A Phase 3 study testing epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 18 sites in 6 countries.
Trial summary
The purpose of the study is to evaluate the safety \& 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
- How many people
- 510 participants
- Where
- 18 sitesin 6 countries
- Study dates
- Jun 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
- Has SLE by ACR revised criteria (meets <4 criteria);
- Has SLE with at least one elevated lupus antibody;
- Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic
Who cannot join
- Active severe CNS or Renal disease defined by BILAG as Level A
- Allergy to murine or human antibodies
- Antiphospholid antibodies AND a history of thrombocytopenic events
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
United States13 sites
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Charleston, South Carolina
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Los Angeles, California
Study site
New York, 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
About this study
Official title: A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems
The purpose of the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.
- 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.
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 posted20 May 2005 (estimated)
- Study startJun 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
- 510 participants
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
- NCT00111306
- Sponsor's protocol ID
- SL0003 (IMMU-103-03)
- Other IDs
- EudraCT #: 2005-000705-59
- Status last verified
- Nov 2011
- First submitted
- 19 May 2005
- Last updated
- 8 Nov 2011
- Results posted
- 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 8 Nov 2011. 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 Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems
- ClinicalTrials.gov ID
- NCT00111306
- Acronym / sponsor ID
- SL0003 (IMMU-103-03)
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Antibody, B-cell immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 510 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 20 May 2005 (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 the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has SLE by ACR revised criteria (meets <4 criteria);
- Has SLE with at least one elevated lupus antibody;
- Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic
Key exclusion criteria (3 listed)
- Active severe CNS or Renal disease defined by BILAG as Level A
- Allergy to murine or human antibodies
- Antiphospholid antibodies AND a history of thrombocytopenic events
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
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 8 Nov 2011.
- 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.
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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
18 sites in 6 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 18 sites in 6 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 3 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 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Belgium, Hungary, Netherlands, Spain and 1 more country. 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 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 NCT00111306, 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 8 Nov 2011.