Systemic Lupus ErythematosusPhase 1/2NCT01449071
Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
A Phase 1/2 study testing Epratuzumab 400 mg, Epratuzumab 1200 mg and Epratuzumab 100 mg in people with Systemic Lupus Erythematosus, run by UCB Pharma at 7 sites in Japan.
Trial summary
The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Epratuzumab 400 mg, Epratuzumab 1200 mg and Epratuzumab 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 7 sitesJapan
- Study dates
- Oct 2011to Mar 2013
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
- Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
- Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment
Who cannot join
- Subjects who are breastfeeding, pregnant, or plan to become pregnant
- Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
- Serious infections
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
09
Fukuoka
10
Fukuoka
11
Fukuoka
03
Kitakyushu
01
Tokyo
08
Tokyo
12
Urayasu
About this study
Official title: A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease
The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Placebo, Epratuzumab 400 mg, Epratuzumab 1200 mg, Epratuzumab 100 mg, Epratuzumab 600 mg
- 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.
PlaceboBiological
Placebo infusions at study weeks 0, 1, 2, and 3.
Epratuzumab 400 mgBiological
Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Epratuzumab 1200 mgBiological
Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Epratuzumab 100 mgBiological
Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Epratuzumab 600 mgBiological
Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Not described Receives: Biological: Placebo |
| Epratuzumab 600 mg Group | Experimental | Not described Receives: Biological: Epratuzumab 600 mg |
| Epratuzumab 100 mg Group | Experimental | Not described Receives: Biological: Epratuzumab 100 mg |
| Epratuzumab 400 mg Group | Experimental | Not described Receives: Biological: Epratuzumab 400 mg |
| Epratuzumab 1200 mg Group | Experimental | Not described Receives: Biological: Epratuzumab 1200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve (AUC)
AUC is defined as the area under the plot of plasma concentration of Epratuzumab against time after administration per subject.
All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate AUC
Measured: From baseline to 12 weeks
Half-life (t1/2)
Half-life is defined as the time taken for plasma concentrations of Epratuzumab to decline by one half per subject.
All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate Half-life.
Measured: From baseline to 12 weeks
Maximum plasma Concentration (Cmax)
Plasma concentration of Epratuzumab for each pharmacokinetics parameter is measured at administration day (day 0, 7, 14, 21) and the next four days of each administration day and week-4, 6, 8, 10, 12.
Measured: From Baseline to 12 weeks
Secondary outcomes (1)
Incidence of anti-epratuzumab in plasma during administration over 12 weeks
Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).
Measured: Day 0 (initial administration day) and week 12 (end of the evaluation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT01449071
- Sponsor's protocol ID
- SL0026
- Status last verified
- Jan 2014
- First submitted
- 3 Oct 2011
- Last updated
- 12 Feb 2014
- 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 33687069Tsuru T, Tanaka Y, Kishimoto M, Saito K, Yoshizawa S, Takasaki Y, Miyamura T, Niiro H, Morimoto S, Yamamoto J, Lledo-Garcia R, Shao J, Tatematsu S, Togo O, Koike T. Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Mod Rheumatol. 2016;26(1):87-93. doi: 10.3109/14397595.2015.1079292. Epub 2015 Oct 19.
PubMed 26382733
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease
- ClinicalTrials.gov ID
- NCT01449071
- Acronym / sponsor ID
- SL0026
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Oct 2011 (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 primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Biological: Placebo |
| Epratuzumab 600 mg Group | Experimental | Biological: Epratuzumab 600 mg |
| Epratuzumab 100 mg Group | Experimental | Biological: Epratuzumab 100 mg |
| Epratuzumab 400 mg Group | Experimental | Biological: Epratuzumab 400 mg |
| Epratuzumab 1200 mg Group | Experimental | Biological: Epratuzumab 1200 mg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
- Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
- Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment
Key exclusion criteria (3 listed)
- Subjects who are breastfeeding, pregnant, or plan to become pregnant
- Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
- Serious infections
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 |
|---|---|---|
| PlaceboPlacebo infusions at study weeks 0, 1, 2, and 3. | Biological | Placebo Group |
| Epratuzumab 400 mgEpratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3. | Biological | Epratuzumab 400 mg Group |
| Epratuzumab 1200 mgEpratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3. | Biological | Epratuzumab 1200 mg Group |
| Epratuzumab 100 mgEpratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3. | Biological | Epratuzumab 100 mg Group |
| Epratuzumab 600 mgEpratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3. | Biological | Epratuzumab 600 mg Group |
Primary outcome
Area under the concentration time curve (AUC)
Time frame: From baseline to 12 weeks
AUC is defined as the area under the plot of plasma concentration of Epratuzumab against time after administration per subject. All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate AUC
Half-life (t1/2)
Time frame: From baseline to 12 weeks
Half-life is defined as the time taken for plasma concentrations of Epratuzumab to decline by one half per subject. All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate Half-life.
Maximum plasma Concentration (Cmax)
Time frame: From Baseline to 12 weeks
Plasma concentration of Epratuzumab for each pharmacokinetics parameter is measured at administration day (day 0, 7, 14, 21) and the next four days of each administration day and week-4, 6, 8, 10, 12.
1 secondary outcome
Incidence of anti-epratuzumab in plasma during administration over 12 weeks
Time frame: Day 0 (initial administration day) and week 12 (end of the evaluation period)
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 12 Feb 2014.
- 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.
- Derived from this study: PubMed 26382733Tsuru T, Tanaka Y, Kishimoto M, Saito K, Yoshizawa S, Takasaki Y, Miyamura T, Niiro H, Morimoto S, Yamamoto J, Lledo-Garcia R, Shao J, Tatematsu S, Togo O, Koike T. Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Mod Rheumatol. 2016;26(1):87-93. doi: 10.3109/14397595.2015.1079292. Epub 2015 Oct 19.
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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)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epratuzumab 400 mg, Epratuzumab 1200 mg and Epratuzumab 100 mg in people with Systemic Lupus Erythematosus, run by UCB Pharma at 7 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 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: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the concentration time curve (AUC) (time frame: From baseline to 12 weeks). The study lists 3 primary outcomes in all. 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 NCT01449071, which also lists 2 linked publications.
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 12 Feb 2014.