A 24-Week Multicenter, Randomized, Open-Label, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients with Moderate-to-Severe Plaque Psoriasis who are Naive to Systemic Treatment

• Register: EUCTR
• Last refreshed on: 22 January 2018
• Main ID: EUCTR2015-002649-69-DE
• Date of registration: 28/07/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: A 24-Week Multicenter, Randomized, Open-Label, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients with Moderate-to-Severe Plaque Psoriasis who are Naive to Systemic Treatment
• Scientific title: A 24-Week Multicenter, Randomized, Open-Label, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients with Moderate-to-Severe Plaque Psoriasis who are Naive to Systemic Treatment
• Date of first enrolment: 09/12/2015
• Target sample size: 162
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002649-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; 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

Germany

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
[1] Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline (Week 0; Visit 2), as determined by the investigator
[2] Patients who are candidates for systemic therapy, and who are naive to systemic treatment for psoriasis.
[3] Have a PASI score =10 and BSA =10 at screening (Visit 1) and at baseline (Week 0, Visit 2)
[4] Are male or female patients of 18 years or older
[5] If a male patient, agree to use a reliable method of birth control during the study and for at least 6 month following the last dose of investigational product. Male patients should not donate sperm during this period.
[6] If a female patient of childbearing potential, must test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 15 weeks following the last dose of investigational product. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
[7] For non-childbearing potential female patients, patients must be:
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)
[8] Have a chest x-ray or results from chest x-ray obtained within 6 months before screening visit
[9] Have given written informed consent approved by Lilly, or its designee, and the Institutional Review Board (IRB)/ERB governing the site

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
10 Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
11 Have a history of drug-induced psoriasis
12 Have received systemic nonbiologic psoriasis therapy
13 Have received natalizumab, or other agents targeting a 4 integrin
14 Have received phototherapy within 4 weeks of baseline or have had topical psoriasis treatment within 2 weeks of baseline
15 Exceptions: low potency to mild potency topical steroids will be permitted for use limited to the face, axilla, groin and/or genitalia Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy
16 Have any condition or contraindication as addressed in the local labeling for methotrexate or FAE that would preclude the patient from participating
18 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, or have participated in a vaccine clinical study within 12 weeks of baseline
19 Have had a vaccination with 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
20 Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient
22 Have had any major surgery within 8 weeks of baseline or will require surgery during the study that would pose an unacceptable risk
23 Have active or history of malignant disease within 5 years prior to baseline
24 Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening that pose an unacceptable risk to the patient or of interfering with the interpretation of data
25 Have ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the patient
26 Presence of significant uncontrolled neuropsychiatric disorder, have history of a suicide attempt, have a score of 3 on Item 12 (Thoughts of Death or Suicide) of the QIDS-SR16 at screening or baseline or are clinically judged by the investigator to be at risk for suicide
27 Have evidence or suspicion of active or latent TB
28 Have a known immunodeficiency
29 Are positive for human immunodeficiency virus serology
30 Have evidence of or test positive for HBV by testing positive for anti-hepatitis B core antibody and HBV DNA positive
31 Have evidence of or test positive for hepatitis C virus.
32 Have a body temperature =38°C at baseline, these patients may be re screened (1 time) =4 weeks after documented resolution of elevated temperature.
34 Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer
35 Are women who are planning to become pregnant, who are pregnant, or who are breast feeding
36 Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline; have had a serious bone or joint infection within 24 weeks of baseline, or have ever had an infection of an artificial joint; or are immunocompromised to an extent such that participation in the study would pose an unacceptable risk
37 Have or have had an infection typical of an immunocompromised host and/or that occurs with increased incidence in an immunocompromised host
38 Have

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
INN or Proposed INN: Ixekizumab
Other descriptive name: LY2439821
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-

Trade Name: FUMADERM initial
Product Name: Fumaderm initial
Pharmaceutical Form: Gastro-resistant tablet
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
CAS Number: 8000050-76-2
Other descriptive name: ETHYL FUMARATE CALCIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 67-
CAS Number: 8000050-77-3
Other descriptive name: ETHYL FUMARATE MAGNESIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
CAS Number: 8000050-78-4
Other descriptive name: ETHYL FUMARATE ZINC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: Lantarel 2,5mg
Product Name: Methotrexat
Pharmaceutical Form: Tablet
Other descriptive name: METHOTREXATE DISODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-

Trade Name: Lantarel 10mg
Product Name: Methotrexat
Pharmaceutical Form: Tablet
Other descriptive name: METHOTREXATE DISODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: FUMADERM
Product Name: Fumaderm
Pharmaceutical Form: Gastro-resistant tablet
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
CAS Number: 8000050-76-2
Other descriptive name: ETHYL FUMARATE CALCIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 87-
CAS Number: 8000050-77-3
Other descriptive name: ETHYL FUMARATE MAGNESIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
CAS Number: 8000050-78-

Primary Outcome(s)

Main Objective: The coprimary objectives of the study are to test whether ixekizumab Q2W/Q4W is superior to FAE and is superior to MTX at Week 24 in the treatment of patients with moderate-to-severe psoriasis who are candidates for systemic therapy as measured by 75% improvement in Psoriasis Area and Severity Index (PASI 75) from baseline assuming, that non-adherent patients are treatment failures.

Primary end point(s): LPLV

Secondary Objective: To assess whether ixekizumab is superior to FAE and is superior to MTX over the course of treatment in the treatment of patients with moderate-to-severe psoriasis who are candidates for systemic therapy assuming that non-adherent patients are treatment failures as measured by efficacy outcomes
To assess whether ixekizumab is superior to FAE and superior to MTX at all study visits in the treatment of patients with moderate-to-severe psoriasis assuming that non-adherent patients are treatment failures as measured by health outcomes assessments
To explore the treatment difference between MTX and FAE with respect to the same outcomes as described above.

Secondary ID(s)

I1F-EW-RHBZ