A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
NAVIGATE
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
3 other identifiers
interventional
872
10 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
85 active sites
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
July 25, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedStudy Start
First participant enrolled
October 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2016
CompletedResults Posted
Study results publicly available
July 17, 2017
CompletedSeptember 12, 2017
August 1, 2017
1.2 years
July 25, 2014
June 14, 2017
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Week 28 through Week 40
Secondary Outcomes (3)
Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
Week 28 through Week 40
Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
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
Week 28
Study Arms (3)
Open-label ustekinumab
EXPERIMENTALDouble-blind guselkumab
EXPERIMENTALDouble-blind ustekinumab
EXPERIMENTALInterventions
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.
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.
Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Unknown Facility
Birmingham, Alabama, United States
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Bakersfield, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Coral Gables, Florida, United States
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Ocala, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Indianapolis, Indiana, United States
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Plainfield, Indiana, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Troy, Michigan, United States
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Buffalo, New York, United States
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New York, New York, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Johnston, Rhode Island, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Webster, Texas, United States
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Norfolk, Virginia, United States
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Spokane, Washington, United States
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Fremantle, Australia
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Victoria Park, Australia
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Woden, Australia
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Woolloongabba, Australia
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Berlin, Germany
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Bonn, Germany
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Essen, Germany
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Gera, Germany
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Hamburg, Germany
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Leipzig, Germany
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Lübeck, Germany
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Mahlow, Germany
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Münster, Germany
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Witten, Germany
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdansk, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Olsztyn, Poland
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Poznan, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Chelyabinsk, Russia
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Krasnodar, Russia
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Lipetsk, Russia
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Saint Petersburg, Russia
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Stavropol, Russia
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Ufa, Russia
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Yekaterinburg, Russia
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Anyang, South Korea
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Incheon, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Alcorcón, Spain
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Alicante, Spain
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Barcelona, Spain
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Madrid, Spain
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Dudley, United Kingdom
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Dundee, United Kingdom
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London, United Kingdom
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Salford, United Kingdom
Related Publications (2)
Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
PMID: 37906417DERIVEDCampbell K, Li K, Yang F, Branigan P, Elloso MM, Benson J, Orlovsky Y, Chen Y, Garcet S, Krueger JG. Guselkumab More Effectively Neutralizes Psoriasis-Associated Histologic, Transcriptomic, and Clinical Measures than Ustekinumab. Immunohorizons. 2023 Apr 1;7(4):273-285. doi: 10.4049/immunohorizons.2300003.
PMID: 37071038DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2014
First Posted
July 29, 2014
Study Start
October 7, 2014
Primary Completion
December 25, 2015
Study Completion
May 24, 2016
Last Updated
September 12, 2017
Results First Posted
July 17, 2017
Record last verified: 2017-08