A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT02411136 |
Recruitment Status :
Completed
First Posted : April 8, 2015
Last Update Posted : April 8, 2015
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Condition or disease | Intervention/treatment | Phase |
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Systemic Lupus Erythematosus | Drug: AMG 623 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: AMG 623
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
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Drug: AMG 623
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
Placebo Comparator: Placebo
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
|
Drug: Placebo
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
- Incidence of treatment emergent adverse events [ Time Frame: up to 31 weeks ]
- Incidence of abnormal clinically significant vital signs [ Time Frame: up to 31 weeks ]
- Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results [ Time Frame: up to 31 weeks ]
- Incidence of abnormal clinically significant ECG results [ Time Frame: up to 31 weeks ]
- Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax [ Time Frame: up to 31 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women between the ages of 18 and 65 years old
- Diagnosis of SLE
- Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization
- SLE disease duration of at least 1 year, as diagnosed by a physician
Exclusion Criteria:
- Current renal disease
- Signs or symptoms of viral or bacterial infection within 30 days of enrollment
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion
- Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to 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): NCT02411136
Study Director: | MD | Amgen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT02411136 |
Other Study ID Numbers: |
20040250 |
First Posted: | April 8, 2015 Key Record Dates |
Last Update Posted: | April 8, 2015 |
Last Verified: | April 2015 |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |