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Trial record 22 of 29 for:    LY2439821

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT02387801
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : October 21, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Ixekizumab
Enrollment 12
Recruitment Details Induction Dosing Period (Weeks 0 up to 12), Maintenance Dosing Period (Weeks 12 up to 48), Minimum Post Treatment Follow-Up Period up to 12 weeks after last visit.
Pre-assignment Details Participants were randomized to ixekizumab (ixe) 80 mg Q2W or Q4W during the Induction Dosing Period from Week 0 to Week 12. Participants received ixe Q4W in the Maintenance Dosing Period from Week 12 to Week 48, and then to the Post Follow up Treatment Period for at least 12 weeks.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
Period Title: Induction Dosing Period
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Maintenance Dosing Period
Started 0 [1] 12
Completed 0 12
Not Completed 0 0
[1]
All participants from Induction Dosing Period went to ixe Q4W arm during Maintenance Dosing Period.
Period Title: Post-Treatment Follow-up
Started 0 12
Completed 0 12
Not Completed 0 0
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W Total
Hide Arm/Group Description 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
41.8  (12.54) 55.2  (7.39) 48.5  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
3
  50.0%
4
  33.3%
Male
5
  83.3%
3
  50.0%
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
2
  33.3%
3
  25.0%
Not Hispanic or Latino
5
  83.3%
4
  66.7%
9
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
0
   0.0%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
1
  16.7%
2
  16.7%
White
4
  66.7%
5
  83.3%
9
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
Hide Description The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Time Frame Baseline through Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description:
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
Overall Number of Participants Analyzed 6 6
Median (90% Confidence Interval)
Unit of Measure: Days
5.0
(2.0 to 5.0)
6.0
(4.0 to 7.0)
2.Secondary Outcome
Title Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
Hide Description The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description:
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.2  (0.53) -6.6  (0.55)
3.Secondary Outcome
Title Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
Hide Description The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “Not at all,” “A little,” "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of “Not relevant” which is scored as “0”. For all questions, if unanswered the question is scored as “0”. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description:
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-13.4  (1.56) -14.3  (1.59)
4.Secondary Outcome
Title Mean Change From Baseline in Percent Body Surface Area (%BSA)
Hide Description The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant’s hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description:
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: percentage of body surface area
-26.1  (1.39) -28.0  (1.39)
5.Secondary Outcome
Title Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description:
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-22.00  (0.456) -22.72  (0.456)
6.Secondary Outcome
Title Time to at Least a 2 Point Improvement on the PatGA Score
Hide Description The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Time Frame Baseline though Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ixekizumab Q2W Ixekizumab Q4W
Hide Arm/Group Description:
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
Overall Number of Participants Analyzed 6 6
Median (90% Confidence Interval)
Unit of Measure: Days
10.0
(6.0 to 12.0)
13.5
(5.0 to 22.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixekizumab Q2W Induction Dosing Period Ixekizumab Q4W Induction Dosing Period Ixekizumab 80 mg Q4W Maintenance Ixekizumab 80 mg Q4W Post-treatment
Hide Arm/Group Description 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44. After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44. All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks.
All-Cause Mortality
Ixekizumab Q2W Induction Dosing Period Ixekizumab Q4W Induction Dosing Period Ixekizumab 80 mg Q4W Maintenance Ixekizumab 80 mg Q4W Post-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ixekizumab Q2W Induction Dosing Period Ixekizumab Q4W Induction Dosing Period Ixekizumab 80 mg Q4W Maintenance Ixekizumab 80 mg Q4W Post-treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ixekizumab Q2W Induction Dosing Period Ixekizumab Q4W Induction Dosing Period Ixekizumab 80 mg Q4W Maintenance Ixekizumab 80 mg Q4W Post-treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      5/6 (83.33%)      9/12 (75.00%)      1/12 (8.33%)    
Gastrointestinal disorders         
Diarrhoea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0
Toothache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders         
Fatigue  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Injection site erythema  1  1/6 (16.67%)  1 1/6 (16.67%)  1 1/12 (8.33%)  3 0/12 (0.00%)  0
Injection site urticaria  1  0/6 (0.00%)  0 2/6 (33.33%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations         
Cellulitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Hordeolum  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Influenza  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0
Localised infection  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin bacterial infection  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Upper respiratory tract infection  1  0/6 (0.00%)  0 1/6 (16.67%)  1 4/12 (33.33%)  4 0/12 (0.00%)  0
Investigations         
Biopsy breast  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0
Biopsy prostate  1  0/5 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/6 (33.33%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Muscle spasms  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders         
Acne  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Hyperhidrosis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Pruritus  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Surgical and medical procedures         
Eye laser surgery  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02387801     History of Changes
Other Study ID Numbers: 15454
I1F-US-RHBO ( Other Identifier: Eli Lilly and Company )
First Submitted: March 9, 2015
First Posted: March 13, 2015
Results First Submitted: August 29, 2016
Results First Posted: October 21, 2016
Last Update Posted: June 20, 2018