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A Study in Participants With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107457
First Posted: April 21, 2010
Last Update Posted: July 25, 2017
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.
Information provided by (Responsible Party):
Eli Lilly and Company
Results First Submitted: April 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Biological: Ixekizumab
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
This study has 3 parts:Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging design (approximately 20-40 weeks [wks]).Treatment durability (sustained efficacy off treatment) from Week 20 up to Week 32 was evaluated during Part A.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part B is an optional extension period with an open-label design (approximately 240 weeks). Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks).

Reporting Groups
  Description
Placebo

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

10 mg Ixekizumab

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

25 mg Ixekizumab

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

75 mg Ixekizumab

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

150 mg Ixekizumab

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

Administered 80 mg ixekizumab SC Q4W through week 344.

120 mg/80 mg Total Ixekizumab

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.


Participant Flow for 2 periods

Period 1:   Part A
    Placebo   10 mg Ixekizumab   25 mg Ixekizumab   75 mg Ixekizumab   150 mg Ixekizumab   120 mg/80 mg Total Ixekizumab
STARTED   27   28   30   29   28   0 [1] 
Received at Least 1 Dose of Study Drug   27   28   30   29   28   0 [1] 
COMPLETED   22   21   29   26   27   0 [1] 
NOT COMPLETED   5   7   1   3   1   0 
Adverse Event                1                2                1                0                0                0 
Withdrawal by Subject                3                3                0                3                1                0 
Lost to Follow-up                0                1                0                0                0                0 
Lack of Efficacy                1                0                0                0                0                0 
Protocol Violation                0                1                0                0                0                0 
[1] 120 mg and 80 mg ixekizumab were administered during Part B and C.

Period 2:   Part B and C
    Placebo   10 mg Ixekizumab   25 mg Ixekizumab   75 mg Ixekizumab   150 mg Ixekizumab   120 mg/80 mg Total Ixekizumab
STARTED   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   120 [2] 
Completed Part B (Week 240)   0   0   0   0   0   74 
Completed Part C   0   0   0   0   0   0 [3] 
Post Treatment Safety Visits   0   0   0   0   0   6 [4] 
COMPLETED   0   0   0   0   0   0 [5] 
NOT COMPLETED   0   0   0   0   0   120 
Adverse Event                0                0                0                0                0                12 
Inclusion/Exclusion Criteria Not Met                0                0                0                0                0                1 
Physician Decision                0                0                0                0                0                3 
Lack of Efficacy                0                0                0                0                0                7 
Lost to Follow-up                0                0                0                0                0                10 
Protocol Violation                0                0                0                0                0                1 
Sponsor Decision                0                0                0                0                0                66 
Withdrawal by Subject                0                0                0                0                0                16 
Clinical Relapse                0                0                0                0                0                4 
[1] Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.
[2] 80 and 120 mg ixekizumab were administered during Part B and C.
[3] Part C was stopped once ixekizumab became available through marketing authorization.
[4] Only participants with neutropenia entered the post treatment safety visits.
[5] No participants completed the study as Part C was stopped.



  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.
All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Placebo

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

10 mg Ixekizumab

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

25 mg Ixekizumab

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

75 mg Ixekizumab

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

150 mg Ixekizumab

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

Administered 80 mg ixekizumab SC Q4W through week 344.

Total Total of all reporting groups

Baseline Measures
   Placebo   10 mg Ixekizumab   25 mg Ixekizumab   75 mg Ixekizumab   150 mg Ixekizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   28   30   29   28   142 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (12.76)   47.65  (11.20)   45.93  (14.53)   46.37  (12.50)   45.97  (13.00)   46.19  (12.71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female   13   12   12   10   14   61 
Male   14   16   18   19   14   81 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino   5   5   7   4   4   25 
Not Hispanic or Latino   22   23   23   25   24   117 
Unknown or Not Reported   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native   0   0   1   1   0   2 
Asian   0   1   0   2   1   4 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   2   0   1   2   2   7 
White   25   27   28   24   25   129 
More than one race   0   0   0   0   0   0 
Unknown or Not Reported   0   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
           
United States   27   27   29   28   28   139 
Denmark   0   1   1   1   0   3 
Baseline in Psoriasis Area and Severity Index (PASI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16.45  (5.26)   19.18  (7.96)   18.55  (4.94)   17.20  (4.26)   17.70  (6.21)   17.83  (5.85) 
[1] PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]).Overall scores range from 0 (no psoriasis) to 72(the most severe disease).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement   [ Time Frame: Week 12 ]

2.  Primary:   Percentage of PASI Improvement From Baseline to 12 Week Endpoint   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:   Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:   Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks   [ Time Frame: Baseline Up to 20 Weeks ]

5.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16   [ Time Frame: Baseline, Week 16 ]

6.  Secondary:   Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16   [ Time Frame: Baseline, Week 16 ]

7.  Secondary:   Change From Baseline in Patient Global Assessment (PatGA) at Week 12   [ Time Frame: Baseline, 12 Weeks ]

8.  Secondary:   Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16   [ Time Frame: Baseline, Week 16 ]

10.  Secondary:   Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))   [ Time Frame: Week 16 ]

11.  Secondary:   Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16   [ Time Frame: Baseline, Week 16 ]

12.  Secondary:   Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16   [ Time Frame: Baseline, Week 16 ]

13.  Secondary:   Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12   [ Time Frame: Baseline, Week 12 ]

15.  Secondary:   Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)   [ Time Frame: Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 ]

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

18.  Secondary:   Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12   [ Time Frame: Baseline, Week 12 ]

19.  Secondary:   Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)   [ Time Frame: Week 32 ]

20.  Secondary:   Percentage of PASI Improvement From Baseline Through 32 Weeks   [ Time Frame: Baseline Through 32 Weeks ]

21.  Secondary:   Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement   [ Time Frame: Week 32 ]

22.  Secondary:   Percentage of Participants With Anti-Ixekizumab Antibodies   [ Time Frame: Baseline through Week 20 ]

23.  Secondary:   Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)   [ Time Frame: Baseline Up to 240 Weeks ]

24.  Secondary:   Number of Treatment Emergent Adverse Events up to 344 Weeks   [ Time Frame: Baseline Up to 344 Weeks ]

25.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Baseline Up to 240 Weeks ]

26.  Secondary:   Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)   [ Time Frame: Week 240 ]

27.  Secondary:   Change From Baseline in Pain Visual Analog Scale (VAS)   [ Time Frame: Baseline Up to 240 Weeks ]

28.  Secondary:   Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis   [ Time Frame: Baseline Up to 240 Weeks ]

29.  Secondary:   Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis   [ Time Frame: Baseline Up to 240 Weeks ]

30.  Secondary:   Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis   [ Time Frame: Baseline Up to 240 Weeks ]

31.  Secondary:   Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement   [ Time Frame: Week 240 ]

32.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI)   [ Time Frame: Baseline Up to 240 Weeks ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107457     History of Changes
Other Study ID Numbers: 12060
I1F-MC-RHAJ ( Other Identifier: Eli Lilly and Company )
First Submitted: April 14, 2010
First Posted: April 21, 2010
Results First Submitted: April 20, 2016
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017