A clinical trial in patients with moderate to severe plaque psoriasis comparing the efficacy and safety of taking a drug called Ixekizumab either every 4 weeks or every 2 weeks.

• Register: EUCTR
• Last refreshed on: 4 September 2017
• Main ID: EUCTR2015-000190-12-DE
• Date of registration: 06/05/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A clinical trial in patients with moderate to severe plaque psoriasis comparing the efficacy and safety of taking a drug called Ixekizumab either every 4 weeks or every 2 weeks.
• Scientific title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis
• Date of first enrolment: 09/07/2015
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000190-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: same product (ixekizumab), different dose Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Canada, Czech Republic, Germany, Hungary, Japan, Korea, Republic of, Mexico, Poland, Romania, Taiwan, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly and Company

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.
or
Are women of non-childbearing potential, defined as:
Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation);
or
Women who are =60 years of age
or
Women =40 and <60 years of age who have had a cessation of menses for =12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (=40 mIU/mL).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93

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.
or
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
[17]Had a live vaccination within 12 weeks prior to baseline, or intend to have a live vaccination during the course of the study or within 12 weeks of completing treatment in this study, or have participated in a vaccine clinical study within 12 weeks prior to baseline. Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with non-live vaccines intended to prevent infectious disease prior to therapy
[18]Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline (Week 0), or intend to have this vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
[19]Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.
[20]Are currently enrolled in, have participated, or discontinued from a clinical trial involving an investigational product or nonapproved use of a drug or device within the last 30 days or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Moderate to severe plaque psoriasis
MedDRA version: 18.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Intervention(s)

Product Name: Ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ixekizumab
Current Sponsor code: LY2439821
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 52 (nonresponder imputation [NRI]).
Week 52 (NRI).

Main Objective: To compare the efficacy of continuous every 2-week (Q2W) dosing versus continuous every 4-week (Q4W) dosing of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis (Ps), as measured by static Physician Global Assessment (sPGA) (0,1) and PASI 75 (75% improvement from baseline in the Psoriasis Area and Severity Index).

Primary end point(s): The proportion of patients achieving sPGA (0,1)
The proportion of patients achieving PASI 75

Secondary Objective: •To compare the efficacy of Q4W step-up dosing to Q2W (Q4W/Q2W step-up) versus continuous Q4W dosing, as measured by sPGA (0,1)
•To compare the efficacy of Q4W/Q2W step-up versus continuous Q4W dosing, as measured by PASI 75
•To compare the efficacy of continuous Q2W dosing versus continuous Q4W dosing of ixekizumab, as measured by sPGA (0).

Secondary Outcome(s)

Secondary end point(s): •Proportion of patients achieving sPGA (0,1)
•Proportion of patients achieving PASI 75
•Proportion of patients achieving sPGA (0)

Timepoint(s) of evaluation of this end point: Week 52 (NRI)
Week 52 (NRI)
Week 52 (NRI).

Secondary ID(s)

I1F-MC-RHBP

Source(s) of Monetary Support

Eli Lilly and Company