Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: 140 mg SC; Drug: 350 mg SC; Drug: 700 mg IV

Detailed Description

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Part A:

• Able to provide written informed consent
• Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
• Additional inclusion criteria apply

Part B:

• 18 - 55 years old inclusive at Screening
• Active but clinically stable, plaque psoriasis
• Psoriasis involving ≥ 10% of the body surface area
• A minimum PASI score of ≥ 10 obtained during the screening period
• Additional inclusion criteria apply

Exclusion Criteria:

Part A:

• History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy)
• Additional exclusion criteria apply

Part B:

• Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
• Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
• Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
• Additional exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo treatment	Drug: Placebo; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Experimental: 140 mg SC; 140 mg SC PsO	Drug: 140 mg SC; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Active Comparator: 350 mg SC; 350 mg SC PsO	Drug: 350 mg SC; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Experimental: 700 mg IV; 700 mg IV PsO	Drug: 700 mg IV; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.	Through day 43
Part B: All Treatment Adverse Events Reported for Safety Evaluation	This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.	85 days
Part A: All Treatment Adverse Events Reported for Safety Evaluation	This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.	Cohort 1-4 43 days, Cohort 5-8 64 days

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Publications and helpful links

General Publications

• Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 20060279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES