Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

This study has been terminated.
(The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01164917
First received: July 15, 2010
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or placebo followed by AMG 811).


Condition Intervention Phase
Cutaneous Lupus
Discoid Lupus
Lupus
Systemic Lupus Erythematosus
Drug: AMG811
Drug: AMG811 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies [ Time Frame: 197 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters, Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score and IFN-gamma related gene expression in skin biopsy samples [ Time Frame: 197 days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: August 2010
Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG811
All will receive AMG 811, either on Day 1 or Day 85
Drug: AMG811
Twelve subjects will be randomized to receive AMG 811 in Period 1 and will receive AMG 811 Placebo in Period 2. The AMG 811 and AMG 811 Placebo will be administered by injection.
Placebo Comparator: AMG811 Placebo
All will receive placebo, either on Day 1 or Day 85
Drug: AMG811 Placebo
8 subjects will be randomized to receive AMG 811 Placebo in Period 1 and will receive AMG 811 in Period 2. The AMG 811 Placebo and AMG 811 will be administered by injection

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization;
  • Diagnosis of discoid lupus erythematosus (DLE) with or without SLE;
  • Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity. The total CLASI activity must be ≥ 10;
  • Stable dose of topical steroids no stronger than medium-potency (Class III or less) for ≥ 2 weeks and/or systemic immunosuppressive therapy at stable dose for ≥ 8 weeks prior to randomization (except for leflunomide which requires ≥ 12 weeks) are permitted;
  • Oral prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent (not to exceed 20 mg/day) will be allowed within 30 days before randomization;

Exclusion Criteria:

  • Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of DLE or SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion;
  • History of malignancy;
  • Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections;
  • Subjects with evidence of past or active tuberculosis
  • Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA) during the screening period;
  • Receipt of a live vaccine within 3 months of study randomization and during the study;
  • Prior use of the following agents:
  • Administration of an investigational biologic agent that primarily targets the immune system -
  • Rituximab, Lymphostat-B, or TACl-Ig within 9 months prior to randomization (or comparable B cell depleting or B cell inhibiting biologics); Rituximab (or other depleting CD20 targeted agents) treated patients must demonstrate a return of CD19+ B cells to > 5/μL;
  • CTLA4-Ig within 3 months prior to randomization;
  • Other agents within 5 half-lives prior to randomization;
  • Administration of cyclosporine, tacrolimus, sirolimus, IV immunoglobulin, and/or plasmapheresis within 3 months of randomization;
  • Administration of thalidomide or lenalidomide within 3 months of randomization;
  • Administration of oral or IV cyclophosphamide (or any other alkylating agent) within 9 months of randomization;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164917

Locations
United States, California
Research Site
Santa Monica, California, United States, 90404
Research Site
Stanford, California, United States, 94305
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48103
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Research Site
Dallas, Texas, United States, 75231
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01164917     History of Changes
Other Study ID Numbers: 20100011
Study First Received: July 15, 2010
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Lupus
Discoid Lupus
Cutaneous Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014