NCT01101100

Brief Summary

This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_2

Geographic Reach
5 countries

21 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

July 18, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

5.4 years

First QC Date

April 1, 2010

Results QC Date

November 8, 2016

Last Update Submit

July 17, 2019

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)

    Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)

    264 weeks

  • Percent Change in Psoriasis Area and Severity Index (PASI)

    Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.

    264 weeks

Study Arms (1)

AMG 827

EXPERIMENTAL

AMG 827

Drug: AMG 827

Interventions

AMG 827DRUG

210 mg SC or 140 mg SC

AMG 827

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject was randomized into Study 20090062 and completed the week 16 evaluation.

You may not qualify if:

  • Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP.
  • Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Newnan, Georgia, 30263, United States

Location

Research Site

Skokie, Illinois, 60077, United States

Location

Research Site

St Louis, Missouri, 63117, United States

Location

Research Site

Albuquerque, New Mexico, 87106, United States

Location

Research Site

Dallas, Texas, 75246, United States

Location

Research Site

Webster, Texas, 77598, United States

Location

Research Site

Kogarah, New South Wales, 2217, Australia

Location

Research Site

Adelaide, South Australia, 5000, Australia

Location

Research Site

Parkville, Victoria, 3050, Australia

Location

Research Site

Prahran, Victoria, 3181, Australia

Location

Research Site

Hamilton, Ontario, L8N 1V6, Canada

Location

Research Site

London, Ontario, N6A 3H7, Canada

Location

Research Site

Markham, Ontario, L3P 1A8, Canada

Location

Research Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Research Site

Windsor, Ontario, N8W 1E6, Canada

Location

Research Site

Québec, Quebec, G1V 4X7, Canada

Location

Research Site

Aarhus, 8000, Denmark

Location

Research Site

Hellerup, 2900, Denmark

Location

Research Site

Besançon, 25030, France

Location

Research Site

Nice, 06200, France

Location

Research Site

Toulouse, 31059, France

Location

Related Publications (3)

  • 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.

    PMID: 25313095BACKGROUND

  • 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.

    PMID: 32207067DERIVED

  • Lebwohl MG, Blauvelt A, Menter A, Papp KA, Guenthner S, Pillai R, Israel RJ, Jacobson A. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2.

    PMID: 31493163DERIVED

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Lindsey Mathew
Organization
Valeant Pharmaceuticals International
lindsey.mathew@valeant.com
908

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 9, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 30, 2019

Results First Posted

July 18, 2019

Record last verified: 2019-07

Locations

US(6)DK(2)AU(4)CA(6)FR(3)