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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203032
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : July 17, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Ustekinumab
Drug: Guselkumab
Drug: Placebo for ustekinumab
Drug: Placebo for guselkumab
Enrollment 872
Recruitment Details  
Pre-assignment Details Study consists of 2 periods: Open label run-in (Period 1) and blinded phase (Period 2). Participants were enrolled in open label run-in period only. Participants completed the open label run-in period entered into blinded phase period.
Arm/Group Title Ustekinumab (Open Label Run-in) 100 mg Guselkumab (Randomized) Ustekinumab (Randomized) Ustekinumab (Nonrandomized Open Label Continuation)
Hide Arm/Group Description All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w. Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40. Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44. Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
Period Title: Open Label Run-in (Week 0 to Week 16)
Started 872 0 0 0
Treated 871 0 0 0
Completed 853 0 0 0
Not Completed 19 0 0 0
Reason Not Completed
Adverse Event             2             0             0             0
Lack of Efficacy             1             0             0             0
Lost to Follow-up             3             0             0             0
Withdrawal by Subject             6             0             0             0
Protocol Violation             4             0             0             0
Other             2             0             0             0
Enrolled but not treated             1             0             0             0
Period Title: Blinded Phase (Week 16 to Week 44)
Started 0 135 133 585
Completed 0 120 107 539
Not Completed 0 15 26 46
Reason Not Completed
Lost to Follow-up             0             2             3             8
Withdrawal by Subject             0             8             19             20
Other             0             4             1             15
Death             0             0             0             1
Completed Safety follow-up             0             1             3             2
Arm/Group Title Ustekinumab (Open Label Run-in)
Hide Arm/Group Description All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
Overall Number of Baseline Participants 871
Hide Baseline Analysis Population Description
Baseline analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 871 participants
<=18 years
4
   0.5%
Between 18 and 65 years
814
  93.5%
>=65 years
53
   6.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 871 participants
43.1  (13.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 871 participants
Female
305
  35.0%
Male
566
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 871 participants
Germany 96
Poland 294
Russia 88
Spain 24
United Kingdom 11
Canada 61
United States 194
Australia 19
Korea, Republic Of 29
Taiwan, Province Of China 55
1.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.
Arm/Group Title Guselkumab (Randomized) Ustekinumab (Randomized)
Hide Arm/Group Description:
Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: visits
1.5  (1.57) 0.7  (1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab (Randomized), Ustekinumab (Randomized)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Row mean score test
Comments [Not Specified]
2.Secondary Outcome
Title Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.
Arm/Group Title Guselkumab (Randomized) Ustekinumab (Randomized)
Hide Arm/Group Description:
Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: visits
2.2  (1.69) 1.1  (1.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab (Randomized), Ustekinumab (Randomized)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Row mean score test
Comments [Not Specified]
3.Secondary Outcome
Title Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.
Arm/Group Title Guselkumab (Randomized) Ustekinumab (Randomized)
Hide Arm/Group Description:
Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: visits
0.9  (1.34) 0.4  (1.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab (Randomized), Ustekinumab (Randomized)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Row mean score test
Comments [Not Specified]
4.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.
Arm/Group Title Guselkumab (Randomized) Ustekinumab (Randomized)
Hide Arm/Group Description:
Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Overall Number of Participants Analyzed 135 133
Measure Type: Number
Unit of Measure: percentage of participants
31.1 14.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab (Randomized), Ustekinumab (Randomized)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Up to Week 60
Adverse Event Reporting Description Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.
 
Arm/Group Title Ustekinumab (Open Label Run-in) 100 mg Guselkumab (Randomized) Ustekinumab (Randomized) Ustekinumab (Nonrandomized Open Label Continuation)
Hide Arm/Group Description All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w. Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40. Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44. Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
All-Cause Mortality
Ustekinumab (Open Label Run-in) 100 mg Guselkumab (Randomized) Ustekinumab (Randomized) Ustekinumab (Nonrandomized Open Label Continuation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Ustekinumab (Open Label Run-in) 100 mg Guselkumab (Randomized) Ustekinumab (Randomized) Ustekinumab (Nonrandomized Open Label Continuation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/871 (1.26%)   9/135 (6.67%)   6/133 (4.51%)   20/585 (3.42%) 
Blood and lymphatic system disorders         
Lymphadenopathy * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Cardiac disorders         
Acute Myocardial Infarction * 1  0/871 (0.00%)  0/135 (0.00%)  1/133 (0.75%)  1/585 (0.17%) 
Angina Unstable * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Atrial Fibrillation * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Myocardial Infarction * 1  0/871 (0.00%)  2/135 (1.48%)  0/133 (0.00%)  0/585 (0.00%) 
Sinus Node Dysfunction * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Eye disorders         
Blindness * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Cataract * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  2/585 (0.34%) 
Retinal Artery Embolism * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Retinal Detachment * 1  0/871 (0.00%)  0/135 (0.00%)  1/133 (0.75%)  0/585 (0.00%) 
Gastrointestinal disorders         
Gastritis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Constipation * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Large Intestinal Stenosis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
General disorders         
Chest Pain * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Chest Discomfort * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Hepatobiliary disorders         
Bile Duct Stenosis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Cholecystitis * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Infections and infestations         
Anal Abscess * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Diverticulitis * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Paraspinal Abscess * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Periodontitis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Pneumonia Bacterial * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Arthritis Bacterial * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Appendicitis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Epididymitis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Salpingitis * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Injury, poisoning and procedural complications         
Alcohol Poisoning * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Contusion * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Scapula Fracture * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Tibia Fracture * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Toxicity to Various Agents * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Metabolism and nutrition disorders         
Diabetes Mellitus * 1  0/871 (0.00%)  0/135 (0.00%)  1/133 (0.75%)  0/585 (0.00%) 
Type 2 Diabetes Mellitus * 1  0/871 (0.00%)  0/135 (0.00%)  1/133 (0.75%)  0/585 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back Pain * 1  0/871 (0.00%)  0/135 (0.00%)  1/133 (0.75%)  0/585 (0.00%) 
Foot Deformity * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bile Duct Cancer * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Pancreatic Carcinoma Metastatic * 1  0/871 (0.00%)  0/135 (0.00%)  0/133 (0.00%)  1/585 (0.17%) 
Transitional Cell Carcinoma * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Squamous Cell Carcinoma * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Nervous system disorders         
Syncope * 1  1/871 (0.11%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Migraine * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Ectopic Pregnancy * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Abortion Spontaneous * 1  0/871 (0.00%)  1/135 (0.74%)  0/133 (0.00%)  0/585 (0.00%) 
Skin and subcutaneous tissue disorders         
Psoriasis * 1  2/871 (0.23%)  0/135 (0.00%)  0/133 (0.00%)  0/585 (0.00%) 
Eczema * 1  0/871 (0.00%)  0/135 (0.00%)  1/133 (0.75%)  0/585 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ustekinumab (Open Label Run-in) 100 mg Guselkumab (Randomized) Ustekinumab (Randomized) Ustekinumab (Nonrandomized Open Label Continuation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   80/871 (9.18%)   37/135 (27.41%)   33/133 (24.81%)   60/585 (10.26%) 
Infections and infestations         
Nasopharyngitis * 1  47/871 (5.40%)  23/135 (17.04%)  23/133 (17.29%)  33/585 (5.64%) 
Upper Respiratory Tract Infection * 1  33/871 (3.79%)  15/135 (11.11%)  11/133 (8.27%)  27/585 (4.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02203032    
Other Study ID Numbers: CR104918
CNTO1959PSO3003 ( Other Identifier: Janssen Research & Development, LLC )
2014-000721-20 ( EudraCT Number )
First Submitted: July 25, 2014
First Posted: July 29, 2014
Results First Submitted: June 14, 2017
Results First Posted: July 17, 2017
Last Update Posted: September 12, 2017