Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01164917
• Other study ID #: 20100011
• Status: Terminated
• Phase: Phase 1
• First received: July 15, 2010
• Last updated: September 12, 2014
• Start date: August 2010
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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;

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

Related Conditions & MeSH terms

• Cutaneous Lupus
• Discoid Lupus
• Lupus
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Atlanta	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Durham	North Carolina
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Santa Monica	California
United States	Research Site	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		197 days	Yes
Secondary	PK parameters, Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score and IFN-gamma related gene expression in skin biopsy samples		197 days	Yes

External Links

•   AmgenTrials clinical trials website