Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT01164917 |
Recruitment Status
:
Terminated
(The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili)
First Posted
: July 19, 2010
Last Update Posted
: September 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cutaneous Lupus Discoid Lupus Lupus Systemic Lupus Erythematosus | Drug: AMG811 Drug: AMG811 Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: AMG811
All will receive AMG 811, either on Day 1 or Day 85
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Drug: AMG811
Twelve subjects will be randomized to receive AMG 811 in Period 1 and will receive AMG 811 Placebo in Period 2. The AMG 811 and AMG 811 Placebo will be administered by injection.
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Placebo Comparator: AMG811 Placebo
All will receive placebo, either on Day 1 or Day 85
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Drug: AMG811 Placebo
8 subjects will be randomized to receive AMG 811 Placebo in Period 1 and will receive AMG 811 in Period 2. The AMG 811 Placebo and AMG 811 will be administered by injection
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- Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies [ Time Frame: 197 days ]
- PK parameters, Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score and IFN-gamma related gene expression in skin biopsy samples [ Time Frame: 197 days ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164917
United States, California | |
Research Site | |
Santa Monica, California, United States, 90404 | |
Research Site | |
Stanford, California, United States, 94305 | |
United States, Georgia | |
Research Site | |
Atlanta, Georgia, United States, 30322 | |
United States, Michigan | |
Research Site | |
Ann Arbor, Michigan, United States, 48103 | |
United States, North Carolina | |
Research Site | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Research Site | |
Dallas, Texas, United States, 75231 | |
United States, Utah | |
Research Site | |
Salt Lake City, Utah, United States, 84107 |
Study Director: | MD | Amgen |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01164917 History of Changes |
Other Study ID Numbers: |
20100011 |
First Posted: | July 19, 2010 Key Record Dates |
Last Update Posted: | September 16, 2014 |
Last Verified: | September 2014 |
Keywords provided by Amgen:
Lupus Discoid Lupus Cutaneous Lupus |
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Lupus Erythematosus, Cutaneous Skin Diseases |