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Trial record 5 of 7 for:    tofacitinib topical

Tofacitinib Ointment For Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01831466
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Psoriasis Vulgaris
Psoriasis
Interventions: Drug: tofacitinib ointment 20 mg/g
Drug: tofacitinib ointment 10 mg/g
Drug: placebo ointment (vehicle)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with mild (PGA-C score of 2), moderate (PGA-C score of 3), or severe (PGA-C score of 4) chronic plaque psoriasis were recruited for this study. The primary analysis population for this study included only the participants with mild and moderate disease.

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
Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID) Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Mild/Moderate: Placebo (Vehicle) BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD) Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Mild/Moderate: Placebo (Vehicle) QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Severe: Tofacitinib 20 mg/g BID Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Severe: Tofacitinib 10 mg/g BID Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Severe: Placebo (Vehicle) BID Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
Severe: Tofacitinib 20 mg/g QD Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Severe: Tofacitinib 10 mg/g QD Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Severe: Placebo (Vehicle) QD Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.

Participant Flow:   Overall Study
    Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)   Mild/Moderate: Tofacitinib 10 mg/g BID   Mild/Moderate: Placebo (Vehicle) BID   Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)   Mild/Moderate: Tofacitinib 10 mg/g QD   Mild/Moderate: Placebo (Vehicle) QD   Severe: Tofacitinib 20 mg/g BID   Severe: Tofacitinib 10 mg/g BID   Severe: Placebo (Vehicle) BID   Severe: Tofacitinib 20 mg/g QD   Severe: Tofacitinib 10 mg/g QD   Severe: Placebo (Vehicle) QD
STARTED   71 [1]   70 [1]   71 [1]   70 [1]   74 [1]   74 [1]   7 [1]   7 [1]   7 [1]   7 [1]   6 [1]   7 [1] 
COMPLETED   55   52   48   51   57   48   6   5   4   2   4   3 
NOT COMPLETED   16   18   23   19   17   26   1   2   3   5   2   4 
Protocol Violation                1                1                2                0                0                1                0                0                0                0                0                0 
Not specified                2                3                2                2                2                1                0                0                0                0                0                0 
Non-compliance with study treatment                2                1                1                0                0                1                0                0                0                0                0                0 
Death                0                1                0                0                0                0                0                0                0                0                0                0 
Withdrawal by Subject                6                3                3                3                3                5                0                0                0                1                0                1 
Lost to Follow-up                0                1                4                2                0                3                0                0                0                1                0                1 
Lack of Efficacy                5                8                7                6                9                8                1                1                2                2                2                0 
Adverse Event                0                0                4                6                3                7                0                1                1                1                0                2 
[1] Treated



  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.
Full Analysis Set (FAS) - included all participants who were randomized to the study, received at least one dose of the randomized investigational drug (tofacitinib or vehicle), and were in a baseline PGA-C category of mild (2), moderate (3) or severe (4).

Reporting Groups
  Description
Mild/Moderate: Tofacitinib 20 mg/g BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Mild/Moderate: Placebo (Vehicle) BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Mild/Moderate: Tofacitinib 20 mg/g QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Mild/Moderate: Placebo (Vehicle) QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Severe: Tofacitinib 20 mg/g BID Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Severe: Tofacitinib 10 mg/g BID Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Severe: Placebo (Vehicle) BID Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
Severe: Tofacitinib 20 mg/g QD Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Severe: Tofacitinib 10 mg/g QD Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Severe: Placebo (Vehicle) QD Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Mild/Moderate: Tofacitinib 20 mg/g BID   Mild/Moderate: Tofacitinib 10 mg/g BID   Mild/Moderate: Placebo (Vehicle) BID   Mild/Moderate: Tofacitinib 20 mg/g QD   Mild/Moderate: Tofacitinib 10 mg/g QD   Mild/Moderate: Placebo (Vehicle) QD   Severe: Tofacitinib 20 mg/g BID   Severe: Tofacitinib 10 mg/g BID   Severe: Placebo (Vehicle) BID   Severe: Tofacitinib 20 mg/g QD   Severe: Tofacitinib 10 mg/g QD   Severe: Placebo (Vehicle) QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   70   71   70   74   74   7   7   7   7   6   7   471 
Age, Customized 
[Units: Participants]
                         
< 18 years   0   0   0   0   0   0   0   0   0   0   0   0   0 
18-44 years   30   23   25   21   30   25   2   0   1   3   3   2   165 
45-64 years   28   34   34   38   35   39   4   6   4   2   2   2   228 
>= 65 years   13   13   12   11   9   10   1   1   2   2   1   3   78 
Gender 
[Units: Participants]
                         
Female   28   23   30   33   24   32   1   3   1   1   0   0   176 
Male   43   47   41   37   50   42   6   4   6   6   6   7   295 


  Outcome Measures

1.  Primary:   Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8   [ Time Frame: Baseline, Week 8 ]

3.  Secondary:   Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:   Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8   [ Time Frame: Week 8 ]

5.  Secondary:   Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8   [ Time Frame: Baseline, Week 8 ]

7.  Secondary:   Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Percent Change From Baseline to Week 8 in PASI   [ Time Frame: Baseline, Week 8 ]

9.  Secondary:   Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8   [ Time Frame: Baseline, Week 8 ]

11.  Secondary:   Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:   Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis   [ Time Frame: Baseline, Week 8 ]

13.  Secondary:   Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Change From Baseline to Week 8 in Clinic-Based ISI Scores   [ Time Frame: Baseline, Week 8 ]

15.  Secondary:   Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Change From Baseline to Week 8 in the DLQI Total Score   [ Time Frame: Baseline, Week 8 ]

17.  Secondary:   Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline   [ Time Frame: Baseline, Week 12 ]

18.  Secondary:   Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline   [ Time Frame: Baseline, Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  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
Efficacy results for participants in the severe population were not reported since this was considered an exploratory population.


  More Information

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01831466     History of Changes
Other Study ID Numbers: A3921082
2012-005645-20 ( EudraCT Number )
First Submitted: March 28, 2013
First Posted: April 15, 2013
Results First Submitted: September 15, 2015
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015