A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

AstraZeneca AB0 sites544 target enrollmentMay 19, 2011

ConditionsSystemic Lupus Erythematosus MedDRA version: 13.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Systemic Lupus Erythematosus
Sponsor: AstraZeneca AB
Enrollment: 544
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 19, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1\) Able to comprehend and complete the informed consent, and all protocol\-related subject assessments.
•2\) Age 18\-75 years.
•3\) Written informed consent.
•4\) Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be: a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR b) Elevated anti\-dsDNA or Sm antibody at screening as determined by central lab
•5\) Weight \= 40\.0 kg.
•6\) Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for \= 24 weeks prior to screening.
•7\) Receiving at least one of the following (at stable doses) prior to signing ICF through Day 1: a) prednisone (or equivalent) \= 20 mg/day for at least 2 weeks; b) one of the following for at least 8 weeks: azathioprine, an antimalarial, mycophenolate mofetil/ mycophenolic acid, weekly administrations of oral or SC methotrexate.
•8\) External Adjudication Group confirmation of both: a) SLEDAI\-2K score \= 6 points or ‘Clinical’ SLEDAI\-2K score \= 6 points; b) At least one of the following: i) BILAG\-2004 Index level A disease in \= 1 body/organ system ii) BILAG\-2004 Index level B disease in \= 2 body/organ systems.
•9\) Day 1 ‘Clinical’ SLEDAI\-2K score \= screening Clinical” SLEDAI\-2K score.
•10\) Physicians Global assessment (MDGA) \= 1\.0 on a 0\-3 scale at screening.

Exclusion Criteria

•1\) Any condition that would interfere with evaluation of the IMP or interpretation of subject safety or study results.
•2\) Concurrent enrollment in any other study with an IMP within 4 weeks prior to Day 1 or within 5 half\-lives of the IMP used in that study, whichever is longer.
•3\) Employees of the study site or any other individuals involved with the study or immediate family members.
•4\) Receipt of any of: a) any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) from 2 weeks prior to signing of the ICF through Day 1; b) any new dose or change in current dose of any of the following anytime in the 8 weeks prior to signing of the ICF through Day 1: azathioprine; any antimalarial; mycophenolate mofetil/mycophenolic acid; oral methotrexate; or SC methotrexate.
•5\) Receipt of any of the following: a) azathioprine \> 150 mg/day; b) mycophenolate mofetil/mycophenolic acid \> 3\.0 grams/day; c) oral or SC methotrexate \> 20 mg/week; d) any change in route of administration of oral or SC methotrexate anytime within the 8 weeks prior to signing of the ICF.
•6\) Receipt of more than one dose of sifalimumab prior to screening.
•7\) Receipt of a biologic agent within 5 half\-lives or prior to loss of PD and/or clinical effect, whichever is longer, prior to signing of the ICF.
•8\) A known history of allergy or reaction to any component of the IMP formulation or history of anaphylaxis to any human gamma globulin therapy.
•9\) Receipt of more than one prescribed NSAID at an anti\-inflammatory dose within 2 weeks (14 days) prior to Day 1; OR receipt of fluctuating doses of a prescribed NSAID within 2 weeks (14 days) prior to Day 1;.
•10\) Receipt of any of the following: a) any live vaccine within 4 weeks prior to signing the ICF; b) oral anti\-infectives (including antivirals) for active infection within 2 weeks prior to Day 1; c) BCG vaccine within 1 year of signing the ICF; d) any restricted medication (as listed in Appendix 3 of the protocol).