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

NCT02411136 | Completed Phase 1

• 1 other identifier: 20040250
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment emergent adverse events

  up to 31 weeks

• Incidence of abnormal clinically significant vital signs

  up to 31 weeks

• Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

  up to 31 weeks

• Incidence of abnormal clinically significant ECG results

  up to 31 weeks

Secondary Outcomes (1)

• Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

  up to 31 weeks

Study Arms (2)

AMG 623

EXPERIMENTAL

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Drug: AMG 623

Placebo

PLACEBO COMPARATOR

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Drug: Placebo

Interventions

AMG 623 DRUG

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

AMG 623

Placebo DRUG

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• 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.

  PMID: 26290435 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: May 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 8, 2015

Record last verified: 2015-04