A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus

• ClinicalTrials.gov Identifier: NCT02411136
• Recruitment Status: Completed
• First Posted: April 8, 2015
• Last Update Posted: April 8, 2015
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: April 3, 2015
• First Posted Date: April 8, 2015
• Last Update Posted Date: April 8, 2015
• Study Start Date: May 2005
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: April 7, 2015): Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax [ Time Frame: up to 31 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

• 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

• 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(1):215. doi: 10.1186/s13075-015-0741-z.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2015): 64
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02411136
• Other Study ID Numbers: 20040250
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Amgen
• Original Responsible Party: Same as current
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: April 2015