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
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Ixekizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||August 2016|
Experimental: Ixekizumab Dosing Q2W
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.
Other Name: LY2439821
Experimental: Ixekizumab Dosing Q4W
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.
Other Name: LY2439821
- Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score [ Time Frame: Baseline through Week 12 ]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.
- Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 12 ]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) [ Time Frame: Baseline, Week 12 ]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) [ Time Frame: Baseline, Week 12 ]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) [ Time Frame: Baseline, Week 12 ]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 [ Time Frame: Baseline though Week 12 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387801
|United States, New York|
|Mount Sinai School of Medicine Dermatology Clinical Trials|
|New York, New York, United States, 10029|
|Study Director:||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)||Eli Lilly and Company|