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A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT01483599
First received: November 29, 2011
Last updated: July 5, 2017
Last verified: July 2017
Results First Received: July 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: CNTO 1959 (5 mg)
Drug: CNTO 1959 (15 mg)
Drug: CNTO 1959 (50 mg)
Drug: CNTO 1959 (100 mg)
Drug: CNTO 1959 (200 mg)
Drug: Adalimumab
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Placebo (CP) Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
CNTO1959 5 mg (CP) Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
CNTO1959 15 mg (CP) Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
CNTO1959 50 mg (CP) Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
CNTO1959 100 mg (CP) Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
CNTO1959 200 mg (CP) Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
Adalimumab (CP) Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
Placebo -> 100 mg CNTO1959 (After CP) Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
CNTO1959 5 mg (After CP) Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
CNTO1959 15 mg (After CP) Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
CNTO1959 50 mg (After CP) Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
CNTO1959 100 mg (After CP) Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
CNTO1959 200 mg (After CP) Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
Adalimumab (After CP) Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.

Participant Flow for 2 periods

Period 1:   Controlled Period (CP) (up to Week 16)
    Placebo (CP)   CNTO1959 5 mg (CP)   CNTO1959 15 mg (CP)   CNTO1959 50 mg (CP)   CNTO1959 100 mg (CP)   CNTO1959 200 mg (CP)   Adalimumab (CP)   Placebo -> 100 mg CNTO1959 (After CP)   CNTO1959 5 mg (After CP)   CNTO1959 15 mg (After CP)   CNTO1959 50 mg (After CP)   CNTO1959 100 mg (After CP)   CNTO1959 200 mg (After CP)   Adalimumab (After CP)
STARTED   42   41   41   42   42   42   43   0   0   0   0   0   0   0 
Treated   42   41   41   42   42   41   43   0   0   0   0   0   0   0 
COMPLETED   39   38   41   39   40   38   39   0   0   0   0   0   0   0 
NOT COMPLETED   3   3   0   3   2   4   4   0   0   0   0   0   0   0 
Adverse Event                2                0                0                1                1                4                3                0                0                0                0                0                0                0 
Lost to Follow-up                0                1                0                1                0                0                1                0                0                0                0                0                0                0 
Lack of Efficacy                1                0                0                0                0                0                0                0                0                0                0                0                0                0 
Unspecified                0                2                0                1                1                0                0                0                0                0                0                0                0                0 

Period 2:   After Controlled Period(Week 16-Week 40)
    Placebo (CP)   CNTO1959 5 mg (CP)   CNTO1959 15 mg (CP)   CNTO1959 50 mg (CP)   CNTO1959 100 mg (CP)   CNTO1959 200 mg (CP)   Adalimumab (CP)   Placebo -> 100 mg CNTO1959 (After CP)   CNTO1959 5 mg (After CP)   CNTO1959 15 mg (After CP)   CNTO1959 50 mg (After CP)   CNTO1959 100 mg (After CP)   CNTO1959 200 mg (After CP)   Adalimumab (After CP)
STARTED   0   0   0   0   0   0   0   39   38   41   39   40   38   39 
COMPLETED   0   0   0   0   0   0   0   37   29   37   37   39   35   32 
NOT COMPLETED   0   0   0   0   0   0   0   2   9   4   2   1   3   7 
Death                0                0                0                0                0                0                0                0                1                0                0                0                0                0 
Adverse Event                0                0                0                0                0                0                0                1                1                0                0                0                1                1 
Lost to Follow-up                0                0                0                0                0                0                0                0                1                0                0                1                0                1 
Withdrawal by Subject                0                0                0                0                0                0                0                0                1                0                2                0                0                1 
Lack of Efficacy                0                0                0                0                0                0                0                0                5                0                0                0                1                4 
Unspecified                0                0                0                0                0                0                0                1                0                4                0                0                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Population analyzed included all participants who were randomized.

Reporting Groups
  Description
Placebo Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
CNTO1959 5 mg Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
CNTO1959 15 mg Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
CNTO1959 50 mg Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
CNTO1959 100 mg Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
CNTO1959 200 mg Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Adalimumab Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
Total Total of all reporting groups

Baseline Measures
   Placebo   CNTO1959 5 mg   CNTO1959 15 mg   CNTO1959 50 mg   CNTO1959 100 mg   CNTO1959 200 mg   Adalimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   41   41   42   42   42   43   293 
Age 
[Units: Participants]
Count of Participants
               
<=18 years      0   0.0%      1   2.4%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.3% 
Between 18 and 65 years      41  97.6%      39  95.1%      39  95.1%      41  97.6%      36  85.7%      40  95.2%      35  81.4%      271  92.5% 
>=65 years      1   2.4%      1   2.4%      2   4.9%      1   2.4%      6  14.3%      2   4.8%      8  18.6%      21   7.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (11.97)   45.2  (13.92)   43.8  (13.5)   42.6  (12.14)   45.3  (13.72)   45.1  (10.96)   47.5  (14.91)   44.9  (13.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      14  33.3%      13  31.7%      13  31.7%      12  28.6%      10  23.8%      11  26.2%      13  30.2%      86  29.4% 
Male      28  66.7%      28  68.3%      28  68.3%      30  71.4%      32  76.2%      31  73.8%      30  69.8%      207  70.6% 
Region of Enrollment 
[Units: Participants]
               
Germany   2   2   4   5   4   3   3   23 
Belgium   2   1   0   0   1   1   0   5 
Poland   7   8   7   10   7   8   8   55 
Canada   13   11   11   11   12   14   11   83 
United States   18   19   19   16   18   16   21   127 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16   [ Time Frame: Week 16 ]

2.  Secondary:   Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16   [ Time Frame: Week 16 ]

3.  Secondary:   Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16   [ Time Frame: Week 16 ]

4.  Secondary:   Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40   [ Time Frame: Week 40 ]

5.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16   [ Time Frame: Baseline and Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  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 Leader
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT01483599     History of Changes
Other Study ID Numbers: CR100673
CNTO1959PSO2001 ( Other Identifier: Janssen Inc. )
2011-001066-17 ( EudraCT Number )
Study First Received: November 29, 2011
Results First Received: July 5, 2017
Last Updated: July 5, 2017