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A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NAVIGATE)

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ustekinumab
Guselkumab
Placebo for ustekinumab
Placebo for guselkumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Plaque-type psoriasis, Guselkumab, Ustekinumab, CNTO 1959, Monoclonal antibody

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
  • Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
  • Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
  • Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
  • Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
  • Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
  • Has previously received guselkumab or ustekinumab

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Open-label ustekinumab

Double-blind guselkumab

Double-blind ustekinumab

Arm Description

Outcomes

Primary Outcome Measures

Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Secondary Outcome Measures

Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Full Information

First Posted
July 25, 2014
Last Updated
August 11, 2017
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02203032
Brief Title
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Acronym
NAVIGATE
Official Title
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
December 25, 2015 (Actual)
Study Completion Date
May 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.
Detailed Description
This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Plaque-type psoriasis, Guselkumab, Ustekinumab, CNTO 1959, Monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
872 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label ustekinumab
Arm Type
Experimental
Arm Title
Double-blind guselkumab
Arm Type
Experimental
Arm Title
Double-blind ustekinumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Intervention Description
100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.
Intervention Type
Drug
Intervention Name(s)
Placebo for ustekinumab
Intervention Description
Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.
Intervention Type
Drug
Intervention Name(s)
Placebo for guselkumab
Intervention Description
Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
Primary Outcome Measure Information:
Title
Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
Description
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame
Week 28 through Week 40
Secondary Outcome Measure Information:
Title
Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Time Frame
Week 28 through Week 40
Title
Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
Description
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame
Week 28 through Week 40
Title
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28
Description
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame
Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment) Exclusion Criteria: Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances Has unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration) Has previously received guselkumab or ustekinumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Coral Gables
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Alpharetta
State/Province
Georgia
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Arlington Heights
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Plainfield
State/Province
Indiana
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Johnston
State/Province
Rhode Island
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
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San Antonio
State/Province
Texas
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United States
City
Webster
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Fremantle
Country
Australia
City
Victoria Park
Country
Australia
City
Woden
Country
Australia
City
Woolloongabba
Country
Australia
City
Surrey
State/Province
British Columbia
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Moncton
State/Province
New Brunswick
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Ajax
State/Province
Ontario
Country
Canada
City
Richmond Hill
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Essen
Country
Germany
City
Gera
Country
Germany
City
Hamburg
Country
Germany
City
Leipzig
Country
Germany
City
Lübeck
Country
Germany
City
Mahlow
Country
Germany
City
Munster
Country
Germany
City
Witten
Country
Germany
City
Anyang
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Bialystok
Country
Poland
City
Bydgoszcz
Country
Poland
City
Gdansk
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Olsztyn
Country
Poland
City
Poznan
Country
Poland
City
Poznań
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Łódź
Country
Poland
City
Chelyabinsk
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Krasnodar
Country
Russian Federation
City
Lipetsk
Country
Russian Federation
City
St-Petersburg
Country
Russian Federation
City
Stavropol
Country
Russian Federation
City
Ufa
Country
Russian Federation
City
Alcorcon
Country
Spain
City
Alicante
Country
Spain
City
Barcelona
Country
Spain
City
La Coruña
Country
Spain
City
Madrid
Country
Spain
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Dudley
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
London
Country
United Kingdom
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

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