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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

70 mg SC

210 mg SC

140 mg SC

280 mg SC

Placebo

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

140 mg SC

70 mg SC

280 mg SC

210 mg SC

Placebo

Arm Description

140 mg SC

70 mg SC

280 mg SC

210 mg SC

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00975637

First Posted

September 10, 2009

Last Updated

June 21, 2019

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00975637

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch Health Americas, Inc.

4. Oversight

5. Study Description

Brief 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.

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.

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

198 (Actual)

8. Arms, Groups, and Interventions

Arm Title

140 mg SC

Arm Type

Experimental

Arm Description

140 mg SC

Arm Title

70 mg SC

Arm Type

Experimental

Arm Description

70 mg SC

Arm Title

280 mg SC

Arm Type

Experimental

Arm Description

280 mg SC

Arm Title

210 mg SC

Arm Type

Placebo Comparator

Arm Description

210 mg SC

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

70 mg SC

Other Intervention Name(s)

AMG 827

Intervention Description

70 mg SC

Intervention Type

Drug

Intervention Name(s)

210 mg SC

Other Intervention Name(s)

AMG 827

Intervention Description

210 mg SC

Intervention Type

Drug

Intervention Name(s)

140 mg SC

Other Intervention Name(s)

AMG 827

Intervention Description

140 mg SC

Intervention Type

Drug

Intervention Name(s)

280 mg SC

Other Intervention Name(s)

AMG 827

Intervention Description

280 mg SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo SC

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in Percent of Body Surface Area (BSA) Affected by Psoriasis

Description

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

24079852

Citation

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.

Results Reference

background

PubMed Identifier

22455412

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.

Results Reference

background

PubMed Identifier

25553889

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.

Results Reference

background

PubMed Identifier

32207067

Citation

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.

Results Reference

derived

PubMed Identifier

25313095

Citation

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.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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