Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

NCT ID: NCT01164917

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-03-31

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).

Conditions

Cutaneous Lupus; Discoid Lupus; Lupus; Systemic Lupus Erythematosus

Study Design

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

Study Groups

AMG811

All will receive AMG 811, either on Day 1 or Day 85

Group Type: ACTIVE_COMPARATOR

AMG811

Intervention Type: DRUG

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.

AMG811 Placebo

All will receive placebo, either on Day 1 or Day 85

Group Type: PLACEBO_COMPARATOR

AMG811 Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Locations

Research Site

Santa Monica, California, United States

Research Site

Stanford, California, United States

Research Site

Atlanta, Georgia, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Durham, North Carolina, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Dallas, Texas, United States

Research Site

Salt Lake City, Utah, United States

Countries

United States

References

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-gamma Antibody, in Patients With Discoid Lupus Erythematosus. Arthritis Rheumatol. 2017 May;69(5):1028-1034. doi: 10.1002/art.40052. Epub 2017 Mar 31.

Reference Type: DERIVED

PMID: 28118537 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20100011

Identifier Type: -

Identifier Source: org_study_id