Systemic Lupus ErythematosusPhase 1NCT02306629
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
A Phase 1 study testing Epratuzumab sc and Epratuzumab iv in people with Systemic Lupus Erythematosus, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
Trial summary
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Epratuzumab sc and Epratuzumab iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Apr 2015
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female.
- At the Screening Visit, subject is 18 years to 50 years, inclusive (for Caucasian subjects), or 20 years to 50 years (for Japanese subjects)
- Subject must be in good health (physically and mentally) as determined by the investigator on the basis of medical history
- Subject has a body weight of 45 kg to 90 kg, inclusive, and body mass index (BMI) between 18.0 kg/m2 and 29.9 kg/m2, inclusive
- Japanese subjects are defined as a person carrying a Japanese passport, who is a descendant of 4 Japanese grandparents and has not been outside Japan for more than 5 years prior to screening
- Females of childbearing potential are required to have a negative serum pregnancy test at the Screening Visit and must agree to use an acceptable method of birth control during the study and for a period of 3 months after the administration of investigational medicinal product (IMP)
- Male subjects must agree to use an acceptable method of contraception during the study and for at least 3 months after receiving IMP unless they have undergone vasectomy
Who cannot join
- Subject has donated blood (including through participation in another clinical study) or suffered blood loss (≥450 mL) <60 days prior to dosing, or has donated platelets <14 days prior to dosing
- Subject has active malignancies or a history of malignancy
- Subject has a history of severe or multiple allergies
- Subject has a history of chronic infection, recent serious or life-threatening infection
- Subject with a recurrent history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens
- Subject has a positive HBsAg, anti-HCV or anti-HIV test result during the Screening Period
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- Subject has a history of or a concurrent clinically significant illness, medical condition, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject upon exposure to epratuzumab or confound the results of the study
- Female subjects who are breast feeding, pregnant, or plan to become pregnant during the study or within 3 months following dosing of the IMP
- Subjects who are immunocompromised
- A confirmed positive urine drug screen
- Subject has a history of substance abuse, drug addiction, or alcoholism within 3 years prior to study admission
- Subject is unable or unwilling to stop smoking during the inpatient stay
- Subject has previous exposure to, or has participated in studies with, any other anti-B-cell therapies
- Subject has a medical condition that requires chronic medication
- Subject has received a live vaccine in the month prior to the administration of IMP or is scheduled or expected to receive live vaccines during the study period or for 3 months after administration of the IMP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab sc, Epratuzumab iv
- Keywords
- Systemic Lupus Erythematosus
- 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.
Epratuzumab scBiological
Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,
Epratuzumab ivBiological
Also called CDP3194, EMAB
Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,
| Study group | Role | What they receive |
|---|---|---|
| Epratuzumab dose 1 sc | Experimental | This group of Caucasian and Japanese subjects will receive one single dose 1 of epratuzumab subcutaneous Receives: Biological: Epratuzumab sc |
| Epratuzumab dose 2 sc | Experimental | This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab subcutaneous Receives: Biological: Epratuzumab sc |
| Epratuzumab dose 3 sc | Experimental | This group of Caucasian subjects will receive one single dose 3 of epratuzumab subcutaneous Receives: Biological: Epratuzumab sc |
| Epratuzumab dose 2 iv | Active comparator | This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab as an intra venous infusion Receives: Biological: Epratuzumab iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t))
Measured: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf))
Measured: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Maximum observed plasma concentration (Cmax)
Measured: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Absolute bioavailability of the tested single sc doses
Measured: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Secondary outcomes (2)
Time of observed Cmax (tmax)
Measured: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Apparent terminal half-life (t½)
Measured: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates, Richmond Pharmacology Limited, ACM Global Laboratories, Eurofins, The Doctors Laboratory Ltd
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306629
- Sponsor's protocol ID
- SL0032
- Other IDs
- 2014-000911-15, 2014
- Status last verified
- May 2015
- First submitted
- 29 Nov 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects
- ClinicalTrials.gov ID
- NCT02306629
- Acronym / sponsor ID
- SL0032
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates, Richmond Pharmacology Limited, ACM Global Laboratories, Eurofins, The Doctors Laboratory Ltd
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Dec 2014 (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.
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epratuzumab dose 1 sc | Experimental | Biological: Epratuzumab scThis group of Caucasian and Japanese subjects will receive one single dose 1 of epratuzumab subcutaneous |
| Epratuzumab dose 2 sc | Experimental | Biological: Epratuzumab scThis group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab subcutaneous |
| Epratuzumab dose 3 sc | Experimental | Biological: Epratuzumab scThis group of Caucasian subjects will receive one single dose 3 of epratuzumab subcutaneous |
| Epratuzumab dose 2 iv | Active comparator | Biological: Epratuzumab ivThis group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab as an intra venous infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is male or female.
- At the Screening Visit, subject is 18 years to 50 years, inclusive (for Caucasian subjects), or 20 years to 50 years (for Japanese subjects)
- Subject must be in good health (physically and mentally) as determined by the investigator on the basis of medical history
- Subject has a body weight of 45 kg to 90 kg, inclusive, and body mass index (BMI) between 18.0 kg/m2 and 29.9 kg/m2, inclusive
- Japanese subjects are defined as a person carrying a Japanese passport, who is a descendant of 4 Japanese grandparents and has not been outside Japan for more than 5 years prior to screening
Key exclusion criteria (15 listed)
- Subject has donated blood (including through participation in another clinical study) or suffered blood loss (≥450 mL) <60 days prior to dosing, or has donated platelets <14 days prior to dosing
- Subject has active malignancies or a history of malignancy
- Subject has a history of severe or multiple allergies
- Subject has a history of chronic infection, recent serious or life-threatening infection
- Subject with a recurrent history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens
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 scActive substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous, | Biological | Epratuzumab dose 1 sc, Epratuzumab dose 2 sc, Epratuzumab dose 3 sc |
| Epratuzumab ivAlso: CDP3194, EMABActive substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous, | Biological | Epratuzumab dose 2 iv |
Primary outcome
Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t))
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf))
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Maximum observed plasma concentration (Cmax)
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Absolute bioavailability of the tested single sc doses
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
2 secondary outcomes
Time of observed Cmax (tmax)
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Apparent terminal half-life (t½)
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
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 May 2015.
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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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epratuzumab sc and Epratuzumab iv in people with Systemic Lupus Erythematosus, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
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 7 inclusion and 15 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 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.
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 plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t)) (time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)). The study lists 4 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 12 May 2015.