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A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis (PSTELLAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01550744
First received: March 8, 2012
Last updated: September 19, 2016
Last verified: September 2016
Results First Received: April 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
During this study, two subjects were transferred between sites and counted twice. Hence, a total of 478 subjects were enrolled in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ustekinumab 45 mg/Ustekinumab 90 mg Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
Group 1: Approved q12w Maintenance Regimen Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
Group 2: Subject-tailored Fixed-interval Maintenance Regimen Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.

Participant Flow for 2 periods

Period 1:   Open-Label
    Ustekinumab 45 mg/Ustekinumab 90 mg   Group 1: Approved q12w Maintenance Regimen   Group 2: Subject-tailored Fixed-interval Maintenance Regimen
STARTED   478   0   0 
COMPLETED   378   0   0 
NOT COMPLETED   100   0   0 
Lost to Follow-up                7                0                0 
Withdrawal by Subject                13                0                0 
Adverse Event                11                0                0 
Lack of Efficacy                4                0                0 
Protocol Violation                4                0                0 
Not all 3 study drug injections received                2                0                0 
Static PGA-cleared/minimal not achieved                58                0                0 
unspecified                1                0                0 

Period 2:   Double-Blind
    Ustekinumab 45 mg/Ustekinumab 90 mg   Group 1: Approved q12w Maintenance Regimen   Group 2: Subject-tailored Fixed-interval Maintenance Regimen
STARTED   0   76   302 
COMPLETED   0   59   235 
NOT COMPLETED   0   17   67 
Lost to Follow-up                0                6                12 
Withdrawal by Subject                0                2                15 
Adverse Event                0                4                15 
Death                0                1                0 
Lack of Efficacy                0                2                8 
Protocol Violation                0                0                4 
Pregnancy                0                0                3 
unspecified                0                2                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The “enrolled subject data set” was defined as all participants enrolled at Week 0 who received at least 1 dose of ustekinumab during the study.

Reporting Groups
  Description
Ustekinumab 45 mg/Ustekinumab 90 mg Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.

Baseline Measures
   Ustekinumab 45 mg/Ustekinumab 90 mg 
Overall Participants Analyzed 
[Units: Participants]
 478 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (14.19) 
Gender 
[Units: Participants]
 
Female   177 
Male   301 
Region of Enrollment 
[Units: Participants]
 
United States   478 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)   [ Time Frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) ]

2.  Secondary:   The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time   [ Time Frame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 ]

3.  Secondary:   The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response   [ Time Frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) ]

4.  Secondary:   The Percentage of Participants With a PASI 75 Response Over Time   [ Time Frame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Director Clinical Research
Organization: Janssen Biotech, Inc
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01550744     History of Changes
Other Study ID Numbers: CR100708
CNTO1275PSO3009 ( Other Identifier: Janssen Biotech, Inc )
Study First Received: March 8, 2012
Results First Received: April 25, 2016
Last Updated: September 19, 2016
Health Authority: United States: Food and Drug Administration