Status:
TERMINATED
Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus
Lead Sponsor:
Amgen
Conditions:
Cutaneous Lupus
Discoid Lupus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 81...
Eligibility Criteria
Inclusion
- Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization;
- Diagnosis of discoid lupus erythematosus (DLE) with or without SLE;
- Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity. The total CLASI activity must be ≥ 10;
- Stable dose of topical steroids no stronger than medium-potency (Class III or less) for ≥ 2 weeks and/or systemic immunosuppressive therapy at stable dose for ≥ 8 weeks prior to randomization (except for leflunomide which requires ≥ 12 weeks) are permitted;
- Oral prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent (not to exceed 20 mg/day) will be allowed within 30 days before randomization;
Exclusion
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of DLE or SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion;
- History of malignancy;
- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections;
- Subjects with evidence of past or active tuberculosis
- Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA) during the screening period;
- Receipt of a live vaccine within 3 months of study randomization and during the study;
- Prior use of the following agents:
- Administration of an investigational biologic agent that primarily targets the immune system -
- Rituximab, Lymphostat-B, or TACl-Ig within 9 months prior to randomization (or comparable B cell depleting or B cell inhibiting biologics); Rituximab (or other depleting CD20 targeted agents) treated patients must demonstrate a return of CD19+ B cells to \> 5/μL;
- CTLA4-Ig within 3 months prior to randomization;
- Other agents within 5 half-lives prior to randomization;
- Administration of cyclosporine, tacrolimus, sirolimus, IV immunoglobulin, and/or plasmapheresis within 3 months of randomization;
- Administration of thalidomide or lenalidomide within 3 months of randomization;
- Administration of oral or IV cyclophosphamide (or any other alkylating agent) within 9 months of randomization;
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01164917
Start Date
August 1 2010
End Date
March 1 2013
Last Update
September 16 2014
Active Locations (8)
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1
Research Site
Santa Monica, California, United States, 90404
2
Research Site
Stanford, California, United States, 94305
3
Research Site
Atlanta, Georgia, United States, 30322
4
Research Site
Ann Arbor, Michigan, United States, 48103