Systemic Lupus ErythematosusPhase 2ADDRESSNCT01440231
Atacicept Demonstrating Dose RESponSe
A Phase 2 study testing Atacicept in people with Systemic Lupus Erythematosus, run by EMD Serono.
Trial summary
Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as… 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?
- Atacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 2014
- 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
- Male or female of ≥18 years of age
- Written informed consent
- Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness
- Disease duration of at least 6 months
- SLEDAI-2K score ≥ 6 at screening
- Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening
- Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential.
Who cannot join
- Increase in dosing of corticosteroids within 2 weeks prior to screening
- Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening
- Change in dosing of immunosuppressants or corticosteroids during the screening period
- Serum IgG < 6g/L
- Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m²
- Urinary protein:creatinine ratio >2 mg/mg
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- History of demyelinating disease
- Breastfeeding or pregnancy
- Legal or limited legal capacity
- Additional exclusion criteria also apply
About this study
Official title: A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined.
A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.
Read more
The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.
The secondary objectives of the trial are:
- To evaluate the effect of atacicept in reducing corticosteroid usage
- To evaluate the safety and tolerability profile of atacicept in subjects with SLE
- To confirm the PK and PD profiles of atacicept in SLE subjects
- To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey [SF-36].
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Placebo, Atacicept
- Keywords
- Rheumatology, Double-Blind, Placebo-Controlled, Multidose, Dose-Response, Phase II, Systemic Lupus Erythematosus, SLE, Atacicept
- 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.
PlaceboDrug
Matching placebo administered by subcutaneous injection, once weekly
AtaciceptDrug
Atacicept 5 mg administered by subcutaneous injection, once weekly
AtaciceptDrug
Atacicept 25 mg administered by subcutaneous injection, once weekly
AtaciceptDrug
Atacicept 75 mg administered by subcutaneous injection, once weekly
AtaciceptDrug
Atacicept 115 mg administered by subcutaneous injection, once weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 2 | Experimental | Not described Receives: Drug: Atacicept |
| Arm 3 | Experimental | Not described Receives: Drug: Atacicept |
| Arm 4 | Experimental | Not described Receives: Drug: Atacicept |
| Arm 5 | Experimental | Not described Receives: Drug: Atacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (trial day 1) in SLEDAI-2K Responder Index-50 (SRI-50) at week 24 of therapy
The SRI-50 is a modification of the SLEDAI-2K, and allows detection of partial improvements (at least 50%) in SLE signs and symptoms assessed by SLEDAI-2K (Systemic Lupus Erythamtosus Disease Activity Index- 2000).
Measured: 24 weeks
Secondary outcomes (6)
Change from baseline to Week 24 in corticosteroid dose
Measured: 24 weeks
Change from baseline in serum Complement C3 levels at week 24 in subjects with low C3 at baseline
Measured: 24 weeks
Change from baseline in serum Complement C4 levels at week 24 in subjects with low C4 at baseline
Measured: 24 weeks
Change from baseline in anti-dsDNA antibodies (in subjects with anti dsDNA ≥30 IU/mL at baseline) and in ANA levels (in subjects with HEp-2 ANA ≥1:80 at baseline) at week 24
Measured: 24 weeks
Change from baseline in levels of total Ig and Ig classes (IgG, IgA, and IgM) at week 24
Measured: 24 weekls
The nature (preferred terms) and incidence of AEs
Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionAug 2013 (estimated)
- Study completionFeb 2014 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Wax, MD, PhD, Study director, EMD Serono, Senior Medical Director, Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440231
- Sponsor's protocol ID
- EMR 700461-018
- Other IDs
- BB-IND 11,584
- Acronym
- ADDRESS
- Status last verified
- Aug 2013
- First submitted
- 22 Sep 2011
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT01440231
- Acronym / sponsor ID
- ADDRESS / EMR 700461-018
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Rheumatology, Double-Blind, Placebo-Controlled, Multidose, Dose-Response, Phase II, Systemic Lupus Erythematosus, SLE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 26 Sep 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.
Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined.
A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.
The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.
The secondary objectives of the trial are:
- To evaluate the effect of atacicept in reducing corticosteroid usage
- To evaluate the safety and tolerability profile of atacicept in subjects with SLE
- To confirm the PK and PD profiles of atacicept in SLE subjects
- To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey [SF-36].
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 |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: Placebo |
| Arm 2 | Experimental | Drug: Atacicept |
| Arm 3 | Experimental | Drug: Atacicept |
| Arm 4 | Experimental | Drug: Atacicept |
| Arm 5 | Experimental | Drug: Atacicept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of ≥18 years of age
- Written informed consent
- Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness
- Disease duration of at least 6 months
- SLEDAI-2K score ≥ 6 at screening
Key exclusion criteria (10 listed)
- Increase in dosing of corticosteroids within 2 weeks prior to screening
- Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening
- Change in dosing of immunosuppressants or corticosteroids during the screening period
- Serum IgG < 6g/L
- Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m²
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 |
|---|---|---|
| PlaceboMatching placebo administered by subcutaneous injection, once weekly | Drug | Arm 1 |
| AtaciceptAtacicept 5 mg administered by subcutaneous injection, once weekly | Drug | Arm 2 |
| AtaciceptAtacicept 25 mg administered by subcutaneous injection, once weekly | Drug | Arm 3 |
| AtaciceptAtacicept 75 mg administered by subcutaneous injection, once weekly | Drug | Arm 4 |
| AtaciceptAtacicept 115 mg administered by subcutaneous injection, once weekly | Drug | Arm 5 |
Primary outcome
Change from baseline (trial day 1) in SLEDAI-2K Responder Index-50 (SRI-50) at week 24 of therapy
Time frame: 24 weeks
The SRI-50 is a modification of the SLEDAI-2K, and allows detection of partial improvements (at least 50%) in SLE signs and symptoms assessed by SLEDAI-2K (Systemic Lupus Erythamtosus Disease Activity Index- 2000).
6 secondary outcomes
Change from baseline to Week 24 in corticosteroid dose
Time frame: 24 weeks
Change from baseline in serum Complement C3 levels at week 24 in subjects with low C3 at baseline
Time frame: 24 weeks
Change from baseline in serum Complement C4 levels at week 24 in subjects with low C4 at baseline
Time frame: 24 weeks
Change from baseline in anti-dsDNA antibodies (in subjects with anti dsDNA ≥30 IU/mL at baseline) and in ANA levels (in subjects with HEp-2 ANA ≥1:80 at baseline) at week 24
Time frame: 24 weeks
Change from baseline in levels of total Ig and Ig classes (IgG, IgA, and IgM) at week 24
Time frame: 24 weekls
The nature (preferred terms) and incidence of AEs
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
Stephen Wax, MD, PhD study director
EMD Serono, Senior Medical Director, Rheumatology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atacicept in people with Systemic Lupus Erythematosus, run by EMD Serono.
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 10 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: withdrawn, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 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 withdrawn before enrolling participants, so there are no results.
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?
Change from baseline (trial day 1) in SLEDAI-2K Responder Index-50 (SRI-50) at week 24 of therapy (time frame: 24 weeks). 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 21 Aug 2013.