Clinical trial NCT02561806: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Chronic plaque psoriasis for at least 6 months before baseline
* Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
* Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
* Concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline
* Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
* Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
* Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
* Have a known allergy or hypersensitivity to latex
* Have had any major surgery within 8 weeks of baseline or will require such during the study
* Have active or history of malignant disease within 5 years prior to baseline
* Significant uncontrolled disorder
* Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
* Are women who are lactating or breast-feeding

Primary outcomes:
measure: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline
timeFrame: Week 12
measure: Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline
timeFrame: Week 12
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline
timeFrame: Week 12
measure: Percentage of Participants With a sPGA (0) Remission
timeFrame: Week 12
measure: Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
timeFrame: Baseline, Week 12
measure: Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Itch Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)
timeFrame: Week 12
measure: Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.
timeFrame: Baseline, Week 12
measure: Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;
timeFrame: Baseline, Week 12
measure: Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score
timeFrame: Baseline, Week 12
measure: Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)
timeFrame: Baseline, Week 12
measure: Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index
timeFrame: Baseline, Week 12
measure: Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS
timeFrame: Baseline, Week 12
measure: Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Wein
country: Austria
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Brussels
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gent
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Calgary
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Edmonton
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Mississauga
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: North Bay
country: Canada
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city: St. John's
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Toronto
country: Canada
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city: Marseille
country: France
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city: Martigues
country: France
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city: Nice
country: France
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city: Rouen
country: France
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city: Toulouse
country: France
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city: Frankfurt am Main
country: Germany
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city: Giessen
country: Germany
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city: Hamburg
country: Germany
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city: Heidelberg
country: Germany
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city: Kiel
country: Germany
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city: Lübeck
country: Germany
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city: München
country: Germany
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city: Tübingen
country: Germany
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city: Witten
country: Germany
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city: Budapest
country: Hungary
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city: Kecskemet
country: Hungary
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city: Szeged
country: Hungary
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city: Szolnok
country: Hungary
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city: Catania
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pisa
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nijmegen
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bialystok
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lodz
country: Poland
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city: Swidnik
country: Poland
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city: Warsaw
country: Poland
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city: Warsaw
country: Poland
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city: Warszawa
country: Poland
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city: Badalona
country: Spain
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city: Barcelona
country: Spain
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city: Madrid
country: Spain
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city: Madrid
country: Spain
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city: Sevilla
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malmö
country: Sweden
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city: Stockholm
country: Sweden
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city: Genève
country: Switzerland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lausanne
country: Switzerland
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city: Zürich
country: Switzerland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Dundee
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Salford
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
citation: Wasel N, Thaci D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.