Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) (APRIL-SLE)

March 11, 2016 updated by: EMD Serono

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
461

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Quilmes, Argentina
        • Research Site
      • San Juan, Argentina
        • Research Site
      • Tucuman, Argentina
        • Research Site
  • Australia
      • Cairns, Australia
        • Research Site
      • Clayton, Victoria, Australia
        • Research Site
      • Sunshine Coast, Queensland, Australia
        • Research Site
      • Woodville S.A., Australia
        • Research Site
  • Austria
      • Wein, Austria
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria
        • Research Site
  • Croatia
      • Osijek, Croatia
        • Research Site
      • Rijeka, Croatia
        • Research Site
      • Split, Croatia
        • Research Site
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Prague, Czech Republic
        • Research Site
  • France
      • Bordeaux Pessac, France
        • Research Site
      • Lille, France
        • Research Site
      • Montpelier Cedex, France
        • Research Site
      • Paris, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Hanover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Herne, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Munster, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • India
      • Secunderabad, Andhra Pradesh, India
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Jerasalem, Israel
        • Research Site
      • Petah-Tikva, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Latvia
      • Riga, Latvia
        • Research Site
  • Lebanon
      • Beirut, Lebanon
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Perak, Malaysia
        • Research Site
      • Seremban, Malaysia
        • Research Site
  • Mexico
      • Guadalajara Jalisco, Mexico
        • Research Site
      • Tijuana, BC, Mexico
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
  • Philippines
      • Davao, Philippines
        • Research Site
      • Iloilo, Philippines
        • Research Site
      • Las Pinas, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
    • Pampanga
      • Angeles City, Pampanga, Philippines
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Gdańsk, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warsawa, Poland
        • Research Site
  • Russian Federation
      • Kemerovo, Russian Federation
        • Research Site
      • Petrozavodsk, Russian Federation
        • Research Site
      • Ryazan, Russian Federation
        • Research Site
      • Saratov, Russian Federation
        • Research Site
      • St Petersburg, Russian Federation
        • Research Site
      • Tula, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Niska Banja, Serbia
        • Research Site
      • Novi Beograd, Serbia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Panorama, Western Cape, South Africa
        • Research Site
      • Parlow, Western Cape, South Africa
        • Research Site
      • Pinelands, South Africa
        • Research Site
      • Stellenbosch, Western Cape, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Santiago de Compostela, Spain
        • Research Site
  • Switzerland
      • St. Gallen, Switzerland
        • Research Site
  • Taiwan
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Ternopil, Ukraine
        • Research Site
      • Vinnytsya, Ukraine
        • Research Site
      • Zhytomyr, Ukraine
        • Research Site
  • United Kingdom
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-7201
        • Division of Clinical Immunology and Rheumatology - UAB
    • California
      • Palo Alto, California, United States
        • Stanford University
      • San Diego, California, United States
        • Research Site
      • Upland, California, United States
        • Inland Rheumatology Clinical Trials INC
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Rockland, Massachusetts, United States, 02370
        • US Local Medical Information
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Lansing, Michigan, United States, 48910
        • Justus J. Fiechtner, MD, MPH
    • New York
      • Brooklyn, New York, United States
        • SUNY Health Science Center at Brooklyn
      • Manhasset, New York, United States, 11030
        • Feinstein Institute for Medical Research
      • New York, New York, United States
        • Research Site
      • New York, New York, United States, 10021
        • Hospital for Special Surgey
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • University of Cincinnati Medical Center, Division of Immunology
    • Texas
      • Temple, Texas, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: 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.
Experimental: Atacicept 75 mg
Drug: 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.
Experimental: Atacicept 150 mg
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From screening up to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First New Flare as Defined by 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. 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.
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
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.
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
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.
Week 52
Mean Cumulative Corticosteroid Dose
Time Frame: Randomization up to Week 52
Randomization up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EMD Serono

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27646

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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