Lupus Erythematosus, SystemicPhase 2/3APRIL-SLENCT00624338
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
A Phase 2/3 study testing Atacicept 75 mg and Atacicept 150 mg in people with Lupus Erythematosus, Systemic, run by EMD Serono at 113 sites in 29 countries.
Trial summary
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Atacicept 75 mg and Atacicept 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 461 participants
- Where
- 113 sitesin 29 countries
- Study dates
- Jan 2008to Oct 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 16 years of age or older
- Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
- Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
- Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
- Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
- Other protocol defined inclusion criteria could apply
Who cannot join
- Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
- Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
- Previous treatment with rituximab, abatacept, or belimumab
- History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
113 sites in 29 countries.
113 sites in 29 countries
United States18 sites
Division of Clinical Immunology and Rheumatology - UAB
Birmingham, Alabama, 35249-7201
Research Site
Boise, Idaho
Brigham and Women's Hospital
Boston, Massachusetts, 02115
SUNY Health Science Center at Brooklyn
Brooklyn, New York
Research Site
Cincinnati, Ohio
University of Cincinnati Medical Center, Division of Immunology
Cincinnati, Ohio
Wayne State University
Detroit, Michigan, 48201
Research Site
Jacksonville, Florida
Justus J. Fiechtner, MD, MPH
Lansing, Michigan, 48910
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Hospital for Special Surgey
New York, New York, 10021
Research Site
New York, New York
Stanford University
Palo Alto, California
US Local Medical Information
Rockland, Massachusetts, 02370
Research Site
San Diego, California
Virginia Mason Medical Center
Seattle, Washington
Research Site
Temple, Texas
Inland Rheumatology Clinical Trials Inc
Upland, California
Germany7 sites
Research Site
Berlin
Research Site
Erlangen
Research Site
Hanover
Research Site
Heidelberg
Research Site
Herne
Research Site
München
Research Site
Münster
Poland7 sites
Research Site
Bialystok
Research Site
Gdansk
Research Site
Krakow
Research Site
Lublin
Research Site
Szczecin
Research Site
Torun
Research Site
Warsaw
Russia7 sites
Research Site
Kemerovo
Research Site
Petrozavodsk
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Saratov
Research Site
Tula
Research Site
Yaroslavl
Ukraine7 sites
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Lviv
Research Site
Ternopil
Research Site
Vinnytsia
Research Site
Zhytomyr
France6 sites
Research Site
Bordeaux Pessac
Research Site
Lille
Research Site
Montpelier Cedex
Research Site
Paris
Research Site
Strasbourg
Research Site
Toulouse
South Africa6 sites
Research Site
Cape Town
Research Site
Durban
Research Site
Panorama, Western Cape
Research Site
Parlow, Western Cape
Research Site
Pinelands
Research Site
Stellenbosch, Western Cape
Argentina5 sites
Research Site
Buenos Aires
Research Site
Córdoba
Research Site
Quilmes
Research Site
San Juan
Research Site
San Miguel de Tucumán
Philippines5 sites
Research Site
Angeles City, Pampanga
Research Site
Davao City
Research Site
Iloilo City
Research Site
Las Piñas
Research Site
Manila
Australia4 sites
Research Site
Cairns
Research Site
Clayton, Victoria
Research Site
Sunshine Coast, Queensland
Research Site
Woodville S.A.
Croatia4 sites
Research Site
Osijek
Research Site
Rijeka
Research Site
Split
Research Site
Zagreb
Israel4 sites
Research Site
Haifa
Research Site
Jerasalem
Research Site
Petah Tikva
Research Site
Tel Aviv
Spain4 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Málaga
Research Site
Santiago de Compostela
Malaysia3 sites
Research Site
Kuala Lumpur
Research Site
Perak
Research Site
Seremban
Netherlands3 sites
Research Site
Amsterdam
Research Site
Leiden
Research Site
Maastricht
Serbia3 sites
Research Site
Belgrade
Research Site
New Belgrade
Research Site
Niška Banja
About this study
Official title: A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Atacicept 75 mg, Atacicept 150 mg, Placebo Comparator
- Keywords
- Atacicept 75 and 150 mg, Placebo
- 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.
Atacicept 75 mgDrug
75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Atacicept 150 mgDrug
150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Placebo ComparatorOther
Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Atacicept 75 mg | Experimental | Not described Receives: Drug: Atacicept 75 mg |
| Atacicept 150 mg | Experimental | Not described Receives: Drug: Atacicept 150 mg |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B
A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Measured: From screening up to Week 52
Secondary outcomes (4)
Time to First New Flare as Defined by BILAG Score A or B
A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Measured: From screening up to Week 52
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks
A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Measured: From screening up to Week 24
Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares
Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Measured: Week 52
Mean Cumulative Corticosteroid Dose
Measured: Randomization up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624338
- Sponsor's protocol ID
- 27646
- Acronym
- APRIL-SLE
- Status last verified
- Mar 2016
- First submitted
- 15 Feb 2008
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.
PubMed 37332136Eslami M, Willen D, Papasouliotis O, Schuepbach-Mallpell S, Willen L, Donze O, Yalkinoglu O, Schneider P. Kinetics of free and ligand-bound atacicept in human serum. Front Immunol. 2022 Dec 2;13:1035556. doi: 10.3389/fimmu.2022.1035556. eCollection 2022.
PubMed 36532058Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20.
PubMed 24951103
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT00624338
- Acronym / sponsor ID
- APRIL-SLE / 27646
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Atacicept 75 and 150 mg, Placebo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Jan 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atacicept 75 mg | Experimental | Drug: Atacicept 75 mg |
| Atacicept 150 mg | Experimental | Drug: Atacicept 150 mg |
| Placebo | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 16 years of age or older
- Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
- Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
- Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
- Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
Key exclusion criteria (5 listed)
- Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
- Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
- Previous treatment with rituximab, abatacept, or belimumab
- History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
- Other protocol defined exclusion criteria could apply
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 |
|---|---|---|
| Atacicept 75 mg75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. | Drug | Atacicept 75 mg |
| Atacicept 150 mg150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. | Drug | Atacicept 150 mg |
| Placebo ComparatorPlacebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. | Other | Placebo |
Primary outcome
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B
Time frame: From screening up to Week 52
A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
4 secondary outcomes
Time to First New Flare as Defined by BILAG Score A or B
Time frame: From screening up to Week 52
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks
Time frame: From screening up to Week 24
Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares
Time frame: Week 52
Mean Cumulative Corticosteroid Dose
Time frame: Randomization up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37332136Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.
- Derived from this study: PubMed 36532058Eslami M, Willen D, Papasouliotis O, Schuepbach-Mallpell S, Willen L, Donze O, Yalkinoglu O, Schneider P. Kinetics of free and ligand-bound atacicept in human serum. Front Immunol. 2022 Dec 2;13:1035556. doi: 10.3389/fimmu.2022.1035556. eCollection 2022.
- Derived from this study: PubMed 24951103Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
113 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atacicept 75 mg and Atacicept 150 mg in people with Lupus Erythematosus, Systemic, run by EMD Serono at 113 sites in 29 countries.
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 6 inclusion and 5 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Germany, Poland, Russia, Ukraine and 24 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B (time frame: From screening up to Week 52). 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 NCT00624338, which also lists 3 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 14 Mar 2016.