Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975637
• Other study ID #: 20090062
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 70 mg SC
70 mg SC
• 210 mg SC
210 mg SC
• 140 mg SC
140 mg SC
• 280 mg SC
280 mg SC
• Placebo
Placebo SC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change in Percent of Body Surface Area (BSA) Affected by Psoriasis	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

External Links

•   AmgenTrials clinical trials website