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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
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date April 8, 2015
Study Start Date  ICMJE May 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax [ Time Frame: up to 31 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
Official Title  ICMJE 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
Brief Summary This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: AMG 623
    Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
  • Drug: Placebo
    Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Study Arms  ICMJE
  • Experimental: AMG 623
    Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
    Intervention: Drug: AMG 623
  • Placebo Comparator: Placebo
    Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
    Intervention: Drug: Placebo
Publications * Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17:215. doi: 10.1186/s13075-015-0741-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02411136
Other Study ID Numbers  ICMJE 20040250
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP