Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Sponsor

Amgen (Industry)

Overall Status

Terminated

CT.gov ID

NCT01164917

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

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

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 [197 days]

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 [197 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Santa Monica	California	United States	90404
2	Research Site	Stanford	California	United States	94305
3	Research Site	Atlanta	Georgia	United States	30322
4	Research Site	Ann Arbor	Michigan	United States	48103
5	Research Site	Durham	North Carolina	United States	27710
6	Research Site	Philadelphia	Pennsylvania	United States	19104
7	Research Site	Dallas	Texas	United States	75231
8	Research Site	Salt Lake City	Utah	United States	84107