A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis

Eli Lilly and Company0 sites1,200 target enrollmentAugust 19, 2015

ConditionsModerate to severe plaque psoriasis MedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe plaque psoriasis
Sponsor: Eli Lilly and Company
Enrollment: 1200
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 19, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•\[1]Present with chronic plaque Ps based on a diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline as determined by the investigator.
•\[2]Have \=10% body surface area (BSA) involvement at screening and baseline.
•\[3]Have both an sPGA score of \=3 and PASI score of \=12 at screening and baseline.
•\[4]Are a candidate for phototherapy and/or systemic therapy.
•\[5]Are male or female patients 18 years or older.
•\[6]If a male patient, patient agrees to use a reliable method of birth control during the study.
•\[7]If a female patient:
•Are women of childbearing potential who are determined to be negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of investigational product, whichever is longer. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel.
•Are women of non\-childbearing potential, defined as:
•Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation);

Exclusion Criteria

•\[9]Have predominant pattern of pustular, erythrodermic, and/or guttate forms of Ps
•\[10]Have a history of drug\-induced Ps
•\[11]Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study, per investigator assessment
•\[12]Have had any of the following therapies within 4 weeks prior to baseline: systemic non\-biologic Ps therapy (including, but not limited to, psoralens and ultraviolet A \[PUVA] light therapy; cyclosporine; corticosteroids; Methotrexate; apremilast; tofacitinib; oral retinoids; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; azathioprine; fumaric acid derivatives; or 1, 25 dihydroxy vitamin D3 and analogs) or phototherapy (including UVB or self\-treatment with tanning beds or therapeutic sunbathing) or topical Ps therapy with psoralens.
•Have had any of the following therapies within 2 weeks prior to baseline: topical Ps treatment (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, emollients, and other non\-prescription topical products containing salicylic acid, or alpha\- or beta\-hydroxyl acids, and medicated shampoos \[for example, those that contain corticosteroids, coal tar, or vitamin D3 analogs])
•Exceptions: topical steroids will be permitted for use limited to the face, axilla, and/or genitalia
•\[13]Concurrent or recent use of any biologic agent within the following washout periods prior to baseline: etanercept \<28 days; infliximab or adalimumab \<60 days; golimumab \<90 days; ustekinumab \<8 months; rituximab \<12 months; secukinumab \<5 months; or any other biologic agent \<5 half\-lives
•\[14]Have ever received natalizumab or other agents that target alpha\-4\-integrin
•\[15]Have previously failed to respond to an IL\-17 antagonist, per investigator assessment
•\[16]Have previously completed or withdrawn from this study, or participated in any other study with ixekizumab