EUCTR2017-002564-40-DE
Active, not recruiting
Phase 1
A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Amgen Inc
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- •\- Age \= 18 years to 60 years at screening.
- •\- Fulfils diagnostic criteria for SLE according to the Systemic Lupus International
- •Collaborating Clinics (SLICC) criteria or by at least 4 of the 11 criteria of the 1997
- •American College of Rheumatology (ACR) classification criteria for SLE, with at
- •least one of the following being present at screening:
- •? Antinuclear antibody 1:80; or
- •? Elevated anti\-dsDNA antibodies
- •\- Phase 2a Subjects Only: At least one of the following at screening:
- •? SLEDAI 2K 6 without including anti\-dsDNA or C3 and C4 complement
Exclusion Criteria
- •cerebritis 1 year prior to screening
- •\- Phase 2a only: Spot urine protein to creatinine ratio \> 2 mg/g at
- •\- Diagnosis of inflammatory joint or skin disease other than SLE which
- •would interfere with SLE disease assessment based on investigator
- •\- Diagnosis of fibromyalgia which would interfere with SLE assessment
- •\- Prosthetic joint infection within 3 years of screening or native joint
- •infection within 1 year prior to screening.
- •\- Active infection (including chronic or localized infections) for which
- •anti\-infectives were indicated within 4 weeks prior to day 1 OR presence
- •of serious infection, defined as requiring hospitalization or intravenous
Outcomes
Primary Outcomes
Not specified
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