NL-OMON35833
Completed
Phase 2
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus - Dose repsonse study with sifalimumab in SLE
Astra Zeneca0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astra Zeneca
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria:
- •1\. In the opinion of the investigator, must have adequate reading and writing abilities such that the subject can comprehend and complete the informed consent, and all protocol\-related subject assessments.
- •2\. Age 18\-75 years at the time of screening.
- •3\. Written informed consent obtained from the subject prior to performing any protocol\-related procedures, including screening evaluations.
- •4\. Fulfils at least 4 of the 11 American College of Rheumatology classification criteria for SLE, one of which must be:
- •a) Significantly positive antinuclear antibody test at screening; OR
- •b) Elevated anti\-dsDNA or Sm antibody at screening.
- •5\. Weight \>\= 40\.0 kg at screening.
- •6\. Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for \>\= 24 weeks (\>\= 168 days) prior to screening.
- •7\. Currently receiving at least one of the following:
Exclusion Criteria
- •1\. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or confound interpretation of subject safety or study results.
- •2\. Concurrent enrollment in any other clinical study with an investigational product within 4 weeks (28 days) prior to Day 1 or within 5 half\-lives of the investigational product used in that clinical study, whichever is longer.
- •3\. Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals.
- •4\. Receipt of any of the following:
- •a) Any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) anytime from 2 weeks (14 days) prior to signing of the informed consent through Day 1\.
- •b) Any new dose or change in current dose of any of the following anytime in the 8 weeks (56 days) prior to signing of the informed consent through Day 1: azathioprine; any antimalarial (eg. chloroquine, hydroxychloroquine, quinacrine); 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.
Outcomes
Primary Outcomes
Not specified
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