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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00624338




Registration number
NCT00624338
Ethics application status
Date submitted
15/02/2008
Date registered
27/02/2008
Date last updated
14/03/2016

Titles & IDs
Public title
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
Scientific 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)
Secondary ID [1] 0 0
27646
Universal Trial Number (UTN)
Trial acronym
APRIL-SLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Systemic 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atacicept 75 mg
Treatment: Drugs - Atacicept 150 mg
Other interventions - Placebo Comparator

Experimental: Atacicept 75 mg -

Experimental: Atacicept 150 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: Atacicept 75 mg
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.

Treatment: Drugs: Atacicept 150 mg
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.

Other interventions: Placebo Comparator
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B
Timepoint [1] 0 0
From screening up to Week 52
Secondary outcome [1] 0 0
Time to First New Flare as Defined by BILAG Score A or B
Timepoint [1] 0 0
From screening up to Week 52
Secondary outcome [2] 0 0
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks
Timepoint [2] 0 0
From screening up to Week 24
Secondary outcome [3] 0 0
Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Mean Cumulative Corticosteroid Dose
Timepoint [4] 0 0
Randomization up to Week 52

Eligibility
Key inclusion criteria
- 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
461
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Cairns
Recruitment hospital [2] 0 0
Research Site - Clayton, Victoria
Recruitment hospital [3] 0 0
Research Site - Sunshine Coast, Queensland
Recruitment hospital [4] 0 0
Research Site - Woodville S.A.
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Clayton, Victoria
Recruitment postcode(s) [3] 0 0
- Sunshine Coast, Queensland
Recruitment postcode(s) [4] 0 0
- Woodville S.A.
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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California
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Washington
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Argentina
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Cordoba
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Quilmes
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San Juan
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Tucuman
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Wein
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Sofia
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Osijek
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Rijeka
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Split
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Zagreb
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Prague
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Lille
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Heidelberg
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Herne
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Athens
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Haifa
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Jerasalem
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Vilnius
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Kemerovo
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Tula
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Serbia
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Belgrade
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Serbia
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Niska Banja
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Serbia
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Cape Town
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Durban
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Parlow, Western Cape
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Pinelands
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Stellenbosch, Western Cape
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Barcelona
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Madrid
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Malaga
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Spain
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Santiago de Compostela
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Switzerland
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St. Gallen
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Taichung
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Taipei
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Taoyuan
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Ukraine
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Donetsk
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Kharkiv
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Kyiv
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Lviv
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Ternopil
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Vinnytsya
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Zhytomyr
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United Kingdom
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London
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United Kingdom
State/province [101] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00624338
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries