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

NCT ID: NCT02411136

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AMG 623

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Group Type: EXPERIMENTAL

AMG 623

Intervention Type: DRUG

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Placebo

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Interventions

AMG 623

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Intervention Type: DRUG

Placebo

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

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.

Reference Type: DERIVED

PMID: 26290435 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20040250

Identifier Type: -

Identifier Source: org_study_id