Back to resultsA Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ixekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
- Active psoriatic skin lesions of plaque psoriasis (Ps)
- Are a candidate for phototherapy and/or systemic therapy
- Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria:
- Are unable to commit to the photography schedule for the duration of the study
- Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
- Serious disorder or illness other than psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Sites / Locations
- Mount Sinai School of Medicine Dermatology Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ixekizumab Dosing Q2W
Ixekizumab Dosing Q4W
Arm 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.
Outcomes
Primary Outcome Measures
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
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.
Secondary Outcome Measures
Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
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.
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
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.
Mean Change From Baseline in Percent Body Surface Area (%BSA)
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
Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
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 to at Least a 2 Point Improvement on the PatGA Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387801
Brief Title
A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Official Title
Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ixekizumab Dosing Q2W
Arm Type
Experimental
Arm 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.
Arm Title
Ixekizumab Dosing Q4W
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
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
Secondary Outcome Measure Information:
Title
Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
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
Title
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
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
Title
Mean Change From Baseline in Percent Body Surface Area (%BSA)
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
Title
Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
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
Title
Time to at Least a 2 Point Improvement on the PatGA Score
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
Active psoriatic skin lesions of plaque psoriasis (Ps)
Are a candidate for phototherapy and/or systemic therapy
Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria:
Are unable to commit to the photography schedule for the duration of the study
Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
Serious disorder or illness other than psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai School of Medicine Dermatology Clinical Trials
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
29785237
Citation
Khattri S, Goldblum O, Solotkin K, Amir Y, Min MS, Ridenour T, Yang FE, Lebwohl M. Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 May;11(5):33-37. Epub 2018 May 1.
Results Reference
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A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
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