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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02203032




Registration number
NCT02203032
Ethics application status
Date submitted
25/07/2014
Date registered
29/07/2014
Date last updated
12/09/2017

Titles & IDs
Public title
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Scientific 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
Secondary ID [1] 0 0
CNTO1959PSO3003
Secondary ID [2] 0 0
CR104918
Universal Trial Number (UTN)
Trial acronym
NAVIGATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo for ustekinumab
Treatment: Drugs - Placebo for guselkumab

Experimental: Open-label ustekinumab -

Experimental: Double-blind guselkumab -

Experimental: Double-blind ustekinumab -


Treatment: Drugs: 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.

Treatment: Drugs: Guselkumab
100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.

Treatment: Drugs: Placebo for ustekinumab
Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.

Treatment: Drugs: Placebo for 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Week 28 through Week 40
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 28 through Week 40
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Week 28 through Week 40
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
Week 28

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fremantle
Recruitment hospital [2] 0 0
- Victoria Park
Recruitment hospital [3] 0 0
- Woden
Recruitment hospital [4] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Fremantle
Recruitment postcode(s) [2] 0 0
- Victoria Park
Recruitment postcode(s) [3] 0 0
- Woden
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Michigan
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New York
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Canada
State/province [18] 0 0
British Columbia
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Essen
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Germany
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Gera
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Lübeck
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Germany
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Mahlow
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Germany
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Munster
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Germany
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Witten
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Korea, Republic of
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Anyang
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Poland
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Bialystok
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Bydgoszcz
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Gdansk
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Krakow
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Lodz
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Lublin
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Olsztyn
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Poznan
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Torun
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Warszawa
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Wroclaw
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Poland
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Lódz
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Krasnodar
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Russian Federation
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Lipetsk
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Russian Federation
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St-Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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Ufa
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Spain
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Alcorcon
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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La Coruña
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Spain
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Madrid
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Dudley
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United Kingdom
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Dundee
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United Kingdom
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London
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United Kingdom
State/province [67] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02203032
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications