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

Amgen1 site in 1 country16 target enrollmentAugust 2010

ConditionsCutaneous Lupus Discoid Lupus Lupus Systemic Lupus Erythematosus

InterventionsAMG811 AMG811 Placebo

DrugsAMG811 AMG811 Placebo

Overview

Phase: Phase 1
Intervention: AMG811
Conditions: Cutaneous Lupus
Sponsor: Amgen
Enrollment: 16
Locations: 1
Primary Endpoint: 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
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

March 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

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;

Arms & Interventions

AMG811

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

Intervention: AMG811

AMG811 Placebo

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

Intervention: AMG811 Placebo

Outcomes

Primary Outcomes

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 Outcomes

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)