- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203032
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NAVIGATE)
August 11, 2017 updated by: Janssen Research & Development, LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
872
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fremantle, Australia
-
Victoria Park, Australia
-
Woden, Australia
-
Woolloongabba, Australia
-
-
-
-
-
Quebec, Canada
-
-
British Columbia
-
Surrey, British Columbia, Canada
-
Vancouver, British Columbia, Canada
-
-
New Brunswick
-
Moncton, New Brunswick, Canada
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
-
-
Ontario
-
Ajax, Ontario, Canada
-
Richmond Hill, Ontario, Canada
-
-
Quebec
-
Montreal, Quebec, Canada
-
-
-
-
-
Berlin, Germany
-
Bonn, Germany
-
Essen, Germany
-
Gera, Germany
-
Hamburg, Germany
-
Leipzig, Germany
-
Lübeck, Germany
-
Mahlow, Germany
-
Munster, Germany
-
Witten, Germany
-
-
-
-
-
Anyang, Korea, Republic of
-
Incheon, Korea, Republic of
-
Seoul, Korea, Republic of
-
-
-
-
-
Bialystok, Poland
-
Bydgoszcz, Poland
-
Gdansk, Poland
-
Krakow, Poland
-
Lodz, Poland
-
Lublin, Poland
-
Olsztyn, Poland
-
Poznan, Poland
-
Poznań, Poland
-
Torun, Poland
-
Warszawa, Poland
-
Wroclaw, Poland
-
Łódź, Poland
-
-
-
-
-
Chelyabinsk, Russian Federation
-
Ekaterinburg, Russian Federation
-
Krasnodar, Russian Federation
-
Lipetsk, Russian Federation
-
St-Petersburg, Russian Federation
-
Stavropol, Russian Federation
-
Ufa, Russian Federation
-
-
-
-
-
Alcorcon, Spain
-
Alicante, Spain
-
Barcelona, Spain
-
La Coruña, Spain
-
Madrid, Spain
-
-
-
-
-
Taichung, Taiwan
-
Tainan, Taiwan
-
Taipei, Taiwan
-
Taoyuan, Taiwan
-
-
-
-
-
Dudley, United Kingdom
-
Dundee, United Kingdom
-
London, United Kingdom
-
Salford, United Kingdom
-
-
-
-
Alabama
-
Birmingham, Alabama, United States
-
-
California
-
Bakersfield, California, United States
-
Los Angeles, California, United States
-
Santa Monica, California, United States
-
-
Florida
-
Coral Gables, Florida, United States
-
Ocala, Florida, United States
-
-
Georgia
-
Alpharetta, Georgia, United States
-
Atlanta, Georgia, United States
-
-
Illinois
-
Arlington Heights, Illinois, United States
-
Chicago, Illinois, United States
-
Skokie, Illinois, United States
-
-
Indiana
-
Indianapolis, Indiana, United States
-
Plainfield, Indiana, United States
-
-
Kentucky
-
Louisville, Kentucky, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Michigan
-
Troy, Michigan, United States
-
-
New York
-
Buffalo, New York, United States
-
New York, New York, United States
-
-
Oregon
-
Portland, Oregon, United States
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States
-
-
Rhode Island
-
Johnston, Rhode Island, United States
-
-
Tennessee
-
Nashville, Tennessee, United States
-
-
Texas
-
Arlington, Texas, United States
-
Austin, Texas, United States
-
Dallas, Texas, United States
-
San Antonio, Texas, United States
-
Webster, Texas, United States
-
-
Virginia
-
Norfolk, Virginia, United States
-
-
Washington
-
Spokane, Washington, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open-label ustekinumab
|
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.
|
Experimental: Double-blind guselkumab
|
100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.
Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.
|
Experimental: Double-blind ustekinumab
|
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.
Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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).
|
Week 28 through Week 40
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
Time Frame: 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.
|
Week 28 through Week 40
|
Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
Time Frame: 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).
|
Week 28 through Week 40
|
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
Time Frame: 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).
|
Week 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2014
Primary Completion (Actual)
December 25, 2015
Study Completion (Actual)
May 24, 2016
Study Registration Dates
First Submitted
July 25, 2014
First Submitted That Met QC Criteria
July 25, 2014
First Posted (Estimate)
July 29, 2014
Study Record Updates
Last Update Posted (Actual)
September 12, 2017
Last Update Submitted That Met QC Criteria
August 11, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR104918
- CNTO1959PSO3003 (Other Identifier: Janssen Research & Development, LLC)
- 2014-000721-20 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
Clinical Trials on Ustekinumab
-
Janssen Research & Development, LLCCompletedPsoriasisUnited States, Germany, Taiwan, Belgium, Korea, Republic of, Canada, Poland, Hungary, Netherlands
-
Janssen Research & Development, LLCCompletedPrimary Biliary CirrhosisUnited States, Canada
-
Samsung Bioepis Co., Ltd.CompletedPsoriasis | Moderate to Severe Plaque PsoriasisCzechia, Estonia, Hungary, Korea, Republic of, Latvia, Lithuania, Poland, Ukraine
-
Jewish General HospitalCompletedType 1 Diabetes MellitusCanada
-
Centocor, Inc.CompletedCrohn's DiseaseUnited States, France, United Kingdom, Germany, Spain, Belgium, Israel, Australia, Canada, Netherlands, New Zealand, Austria
-
Janssen Research & Development, LLCCompletedPsoriasisFrance, Ukraine, United Kingdom, Germany, Portugal, Canada, Belgium, Russian Federation, Hungary, Sweden
-
Bioeq GmbHCompletedPlaque PsoriasisPoland, Estonia, Ukraine, Georgia
-
Centocor, Inc.Completed
-
Janssen Research & Development, LLCWithdrawnLupus Erythematosus, SystemicChina
-
Centocor, Inc.Completed