Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cutaneous Lupus; Discoid Lupus; Lupus; Systemic Lupus Erythematosus	Drug: AMG811; Drug: AMG811 Placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	August 2010
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	March 2013

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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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

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Additional Information:

AmgenTrials clinical trials website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Werth VP, Fiorentino D, Sullivan BA, Boedigheimer MJ, Chiu K, Wang C, Arnold GE, Damore MA, Bigler J, Welcher AA, Russell CB, Martin DA, Chung JB. Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus. Arthritis Rheumatol. 2017 May;69(5):1028-1034. doi: 10.1002/art.40052. Epub 2017 Mar 31.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01164917 History of Changes
Other Study ID Numbers:	20100011
First Posted:	July 19, 2010
Last Update Posted:	September 16, 2014
Last Verified:	September 2014

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