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

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: Ixekizumab

Registration Number: NCT02387801

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ixekizumab Dosing Q2W	Ixekizumab	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.
Ixekizumab Dosing Q4W	Ixekizumab	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.

Primary Outcome Measures

Name	Time	Method
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score	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)	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.
Time to at Least a 2 Point Improvement on the PatGA Score	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.
Mean Change From Baseline in Percent Body Surface Area (%BSA)	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)	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.