Lupus Erythematosus, SystemicPhase 2NCT00113971
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
A Phase 2 study testing epratuzumab in people with Lupus Erythematosus, Systemic, run by UCB Pharma at 3 sites in United States.
Trial summary
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- epratuzumab
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Jun 2007
- 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
- Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
- Has had SLE for at least 6 months prior to study entry
- Has at least one elevated autoantibody level at study entry
- Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry 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
- Prior therapy with other anti-B cell antibodies
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rheumatology Associates
Charleston, South Carolina, 29407
Columbia Presbyterian Medical Center
New York, New York, 10032
Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15261
About this study
Official title: A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
Read the detailed description
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- epratuzumab
- Keywords
- study of epratuzumab in systemic lupus erythematosus, systemic lupus erythematosus, SLE
- 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.
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
Secondary outcomes (1)
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2007
- Study completionJun 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 Lupus Erythematosus, SystemicStudies 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
- 20 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
- NCT00113971
- Sponsor's protocol ID
- SL0002 (IMMU-103-SLE-02)
- Status last verified
- Mar 2012
- First submitted
- 10 Jun 2005
- Last updated
- 3 Apr 2012
- Results posted
- No
Publications
Kaufmann J, Wegener WA, Horak ID, et al. Pilot clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy in systemic lupus erythematosus (SLE) [abstract]. Ann Rheum Dis 2004; 63 (suppl I): Thu0443. (Published online at http://www.eular.org)
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00113971
- Acronym / sponsor ID
- SL0002 (IMMU-103-SLE-02)
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- study of epratuzumab in systemic lupus erythematosus, systemic lupus erythematosus, SLE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Jun 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 goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
Detailed description
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (4 listed)
- Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
- Has had SLE for at least 6 months prior to study entry
- Has at least one elevated autoantibody level at study entry
- Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)
Key exclusion criteria (3 listed)
- Active Severe Lupus as defined by BILAG Index Level A in any body system or organ
- Allergy to human antibodies or Murine
- Prior therapy with other anti-B cell antibodies
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
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
1 secondary outcome
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.
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 3 Apr 2012.
- BackgroundKaufmann J, Wegener WA, Horak ID, et al. Pilot clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy in systemic lupus erythematosus (SLE) [abstract]. Ann Rheum Dis 2004; 63 (suppl I): Thu0443. (Published online at http://www.eular.org)
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epratuzumab in people with Lupus Erythematosus, Systemic, run by UCB Pharma at 3 sites in United States.
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 4 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 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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?
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.. 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 NCT00113971, 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 3 Apr 2012.