Systemic Lupus ErythematosusPhase 2NCT01534403
Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
A Phase 2 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 6 sites in Japan.
Trial summary
The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Epratuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesJapan
- Study dates
- Jan 2012to Feb 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has completed the double-blind study SL0026 [NCT01449071] or terminated prematurely at Week 8 or later in SL0026 [NCT01449071] due to lack of efficacy
- Women of childbearing potential must agree to use an acceptable method of birth control/Written Informed Consent
Who cannot join
- Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A
- Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
- Substance abuse or dependence
- Significant hematologic abnormalities
- History of malignant cancer
- Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
About this study
Official title: A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus
The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab
- Keywords
- Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab
- 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.
EpratuzumabBiological
Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87)
| Study group | Role | What they receive |
|---|---|---|
| Epratuzumab 4x600 mg every 12 weeks Group | Experimental | Not described Receives: Biological: Epratuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)
Measured: up to Week 100
Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96
Measured: From Baseline (Week 0) to Week 96
Secondary outcomes (5)
Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96
Measured: From Baseline (Week 0) to Week 96
Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96
Measured: From Baseline (Week 0) to Week 96
Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96
Measured: From Baseline (Week 0) to Week 96
Epratuzumab plasma concentration at Week 96
Measured: Week 96
Number of subjects reporting anti-Epratuzumab in plasma at Week 96
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534403
- Sponsor's protocol ID
- SL0027
- Status last verified
- Apr 2016
- First submitted
- 13 Feb 2012
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01534403
- Acronym / sponsor ID
- SL0027
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Feb 2012 (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 study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epratuzumab 4x600 mg every 12 weeks Group | Experimental | Biological: Epratuzumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has completed the double-blind study SL0026 [NCT01449071] or terminated prematurely at Week 8 or later in SL0026 [NCT01449071] due to lack of efficacy
- Women of childbearing potential must agree to use an acceptable method of birth control/Written Informed Consent
Key exclusion criteria (6 listed)
- Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A
- Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
- Substance abuse or dependence
- Significant hematologic abnormalities
- History of malignant cancer
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 |
|---|---|---|
| EpratuzumabEpratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87) | Biological | Epratuzumab 4x600 mg every 12 weeks Group |
Primary outcome
Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)
Time frame: up to Week 100
Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
5 secondary outcomes
Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Epratuzumab plasma concentration at Week 96
Time frame: Week 96
Number of subjects reporting anti-Epratuzumab in plasma at Week 96
Time frame: Week 96
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 6 May 2016.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
6 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 Systemic Lupus Erythematosus, run by UCB Pharma at 6 sites in Japan.
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 2 inclusion and 6 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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 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?
Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks) (time frame: up to Week 100). The study lists 2 primary outcomes in all. 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 6 May 2016.