NCT02786732

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to severe plaque psoriasis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

4.8 years

First QC Date

June 23, 2014

Last Update Submit

May 25, 2016

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • PASI Improvement

    12 weeks

Study Arms (4)

210mg Brodalumab

EXPERIMENTAL

Administered by subcutaneous injection until Week 12

Biological: 210mg Brodalumab

140mg Brodalumab

EXPERIMENTAL

Administered subcutaneous injection until Week 12

Biological: 210mg Brodalumab

Ustekinumab

ACTIVE COMPARATOR

Administered subcutaneous injection until Week 52

Biological: 140mg Brodalumab

Placebo

PLACEBO COMPARATOR

Administered subcutaneous injection until Week 12

Biological: 210mg BrodalumabBiological: UstekinumabBiological: Placebo

Interventions

210mg BrodalumabBIOLOGICAL

Brodalumab 210mg administered subcutaneously

140mg Brodalumab210mg BrodalumabPlacebo
140mg BrodalumabBIOLOGICAL

Brodalumab 140mg administered subcutaneously

Ustekinumab
UstekinumabBIOLOGICAL

Ustekinumab 45mg or 90mg adminstered subcutaneously

Placebo
PlaceboBIOLOGICAL

Placebo administered subcutaneously

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP.
  • Subject has involved body surface area \>\_10%, PASI\>\_, and sPGA\>\_3 at screening and at baseline.
  • For women, a negative serum pregnancy test during screening a negative urine pregnancy test at baseline.
  • Subject has no known history of active tuberculosis.
  • Subject has a negative test for tuberculosis during screening.

You may not qualify if:

  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit that would interfere with evaluations of the effect of IP on psoriasis.
  • Subject has a planned surgical intervention between baseline and the week 52 evaluation.
  • Subject an active infection or history of infections.
  • Subject has any systemic disease considered by the investigator to be clinically significant and uncontrolled.
  • Subject has known history of Crohn's disease.
  • Subject has known history of hepatitis B, hepatitis C, or human immunodeficiency virus.
  • Subject had myocardial infarction or unstable angina pectoris within the past 12 months prior to the first dose of IP.
  • Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
  • Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
  • Subject has received live vaccine(s) within 28 days of the first dose of IP.
  • Subject has used ustekinumab and/or antio-IL-17 biologic therapy ever or other experimental or commercially available biologi immune modulator(s) within 12weeks prior to the first IP dose
  • Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).
  • For women not willing to use highly effective methods of birth control during treatment and for 15 weeks after the last dose.
  • For women; pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedDerm Associates

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumabUstekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Michelle T Pelle, M.D.

    MedDerm Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 1, 2016

Study Start

August 1, 2012

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

June 1, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)