Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
700 mg IV
350 mg SC
Placebo
140 mg SC
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Active Comparator
Experimental
Arm Label
Placebo
140 mg SC
350 mg SC
700 mg IV
Arm Description
Placebo treatment
140 mg SC PsO
350 mg SC PsO
700 mg IV PsO
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00867100
First Posted
March 20, 2009
Last Updated
July 26, 2018
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00867100
Brief Title
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Arm Title
140 mg SC
Arm Type
Experimental
Arm Description
140 mg SC PsO
Arm Title
350 mg SC
Arm Type
Active Comparator
Arm Description
350 mg SC PsO
Arm Title
700 mg IV
Arm Type
Experimental
Arm Description
700 mg IV PsO
Intervention Type
Drug
Intervention Name(s)
700 mg IV
Intervention Description
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Intervention Type
Drug
Intervention Name(s)
350 mg SC
Intervention Description
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Intervention Type
Drug
Intervention Name(s)
140 mg SC
Intervention Description
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Primary Outcome Measure Information:
Title
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
Description
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.
Time Frame
Through day 43
Title
Part B: All Treatment Adverse Events Reported for Safety Evaluation
Description
This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
Time Frame
85 days
Title
Part A: All Treatment Adverse Events Reported for Safety Evaluation
Description
This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.
Time Frame
Cohort 1-4 43 days, Cohort 5-8 64 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
22622425
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
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