Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment ixekizumab
Phase phase 3
Sponsor Eli Lilly and Company
Start date April 2015
End date September 2015
Trial size 20 participants
Trial identifier NCT02387801, 15454, I1F-US-RHBO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
ixekizumab LY2439821
Administered SC
(Experimental)
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once every 4 weeks through week 44.
ixekizumab LY2439821
Administered SC

Primary Outcomes

Measure
Time to at Least a 1 Point Change on the Patient's Global Assessment of Disease Severity (PatGA) Score
time frame: Baseline through Week 12

Secondary Outcomes

Measure
Mean Change from Baseline on Itch Numeric Rating Scale (NRS) Score
time frame: Baseline, Week 12
Mean Change from Baseline on the Dermatology Life Quality Index (DLQI)
time frame: Baseline, Week 12
Mean Change from Baseline in Percent Body Surface Area (%BSA)
time frame: Baseline, Week 12
Mean Change from Baseline on the Psoriasis Area and Severity Index (PASI)
time frame: Baseline, Week 12
Time to at Least a 2 Point Change on the PatGA Score
time frame: Baseline though Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.