- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00975637
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
June 21, 2019 updated by: Bausch Health Americas, Inc.
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio.
Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
- Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Exclusion Criteria:
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
- Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
- Subject has any active CTCAE grade 2 or higher infection
- Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
- Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
- Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
- Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
- Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
- Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Placebo
|
Placebo SC
|
Experimental: 140 mg SC
|
140 mg SC
Other Names:
|
Experimental: 70 mg SC
|
70 mg SC
Other Names:
|
Experimental: 280 mg SC
|
280 mg SC
Other Names:
|
Placebo Comparator: 210 mg SC
|
210 mg SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Time Frame: Baseline and 12 weeks
|
At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Percent of Body Surface Area (BSA) Affected by Psoriasis
Time Frame: Baseline and Week 12
|
To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12.
At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred.
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
- Gordon KB, Kimball AB, Chau D, Viswanathan HN, Li J, Revicki DA, Kricorian G, Ortmeier BG. Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory. Br J Dermatol. 2014 Mar;170(3):705-15. doi: 10.1111/bjd.12636.
- Papp KA, Leonardi C, Menter A, Ortonne JP, Krueger JG, Kricorian G, Aras G, Li J, Russell CB, Thompson EH, Baumgartner S. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012 Mar 29;366(13):1181-9. doi: 10.1056/NEJMoa1109017.
- Papp K, Menter A, Strober B, Kricorian G, Thompson EH, Milmont CE, Nirula A, Klekotka P. Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2015 Mar;72(3):436-439.e1. doi: 10.1016/j.jaad.2014.10.026. Epub 2014 Dec 29.
- Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 10, 2009
First Submitted That Met QC Criteria
September 10, 2009
First Posted (Estimate)
September 11, 2009
Study Record Updates
Last Update Posted (Actual)
June 26, 2019
Last Update Submitted That Met QC Criteria
June 21, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20090062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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