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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: Placebo; Drug: 140 mg SC; Drug: 350 mg SC; Drug: 700 mg IV

• Registration Number: NCT00867100
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2016-11-08
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Results First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo treatment
140 mg SC	140 mg SC	140 mg SC PsO
350 mg SC	350 mg SC	350 mg SC PsO
700 mg IV	700 mg IV	700 mg IV PsO

Primary Outcome Measures

Name	Time	Method
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	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.
Part B: All Treatment Adverse Events Reported for Safety Evaluation	85 days	This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
Part A: All Treatment Adverse Events Reported for Safety Evaluation	Cohort 1-4 43 days, Cohort 5-8 64 days	This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.