Safety Study of AMG 557 in Subjects With Lupus Arthritis

NCT01683695 | Completed Phase 1

• 1 other identifier: 20101103
• Study Type: interventional
• Target: 20
• Locations: 8 countries
• Sites: 13

Brief Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

Conditions

Lupus Arthritis, Systemic Lupus Erythematosus

Keywords

Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.

  330 days, including a 21-day screening period

• Lupus Arthritis Response Rate

  Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline

  Day 169

Secondary Outcomes (9)

• Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.

  Day 169

• Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.

  Day 169

• Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.

  Days 85-169

• Proportion of subjects achieving reduction in and maintenance of prednisone (or its

  Days 85-169

• Physician Global Assessment of Disease Activity (PGADA).

  330 days, including a 21-day screening period

Study Arms (2)

AMG 557

ACTIVE COMPARATOR

All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.

Drug: AMG 557

AMG 557 Matching Placebo

PLACEBO COMPARATOR

All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.

Drug: Matching Placebo

Interventions

AMG 557 DRUG

AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.

AMG 557

Matching Placebo DRUG

Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.

AMG 557 Matching 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:

• Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
• Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;

You may not qualify if:

• Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
• Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
• Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
• Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
• Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study

Sponsors & Collaborators

• Amgen: lead

Study Sites (13)

Research Site

Los Angeles, California, 90048, United States

Location

Research Site

San Leandro, California, 94578, United States

Location

Research Site

Danbury, Connecticut, 06810, United States

Location

Research Site

Manhasset, New York, 11030, United States

Location

Research Site

St Leonards, New South Wales, 2065, Australia

Location

Research Site

Odense, 5000, Denmark

Location

Research Site

Lille, 59037, France

Location

Research Site

Berlin, 10117, Germany

Location

Research Site

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Research Site

Kuching, Sarawak, 93586, Malaysia

Location

Research Site

Taipei, 10002, Taiwan

Location

Research Site

Birmingham, B18 7QH, United Kingdom

Location

Research Site

London, WC1E 6JF, United Kingdom

Location

Related Publications (1)

• Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.

  PMID: 29513931 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

AMG 557

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: March 14, 2012
• First Posted: September 12, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

TW (1); MY (2); GB (2); FR (1); AU (1); DK (1); US (4); DE (1)