A Phase 3b Trial of ixekizumab compared to ustekinumab (Stelara) in Moderate to Severe Psoriasis

• Register: EUCTR
• Last refreshed on: 19 February 2018
• Main ID: EUCTR2015-000892-28-SE
• Date of registration: 02/06/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Phase 3b Trial of ixekizumab compared to ustekinumab (Stelara) in Moderate to Severe Psoriasis
• Scientific title: Protocol I1F-MC-RHBS 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 - IXORA - S
• Date of first enrolment: 04/08/2015
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000892-28
• 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: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
-Are at least 18 years of age
-Have had moderate to severe plaque psoriasis for at least 6 months
-Have had a failure, contraindication, or intolerability to at least 1 systemic
therapy (including cyclosporine, methotrexate, or phototherapy)

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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion criteria:
-Have forms of psoriasis other than plaque psoriasis.
-Have recently received certain treatments for their psoriasis (in particular within the last 4 weeks but the restriction can go up to 12 months for some treatments).
-Have received ustekinumab.
-Have already been treated with ixekizumab or another drug with a similar mode of action.
-Have received excessive sun exposure or have used tanning booths within 4 weeks prior to receiving treatment in this study or expect to do so during the study.
-Have recently received a live vaccine (within 12 weeks prior to receiving treatment in this study) or plan to do so during the study.
-Have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
-Have an active or recent infection.
-Have active or dormant tuberculosis.
-Have a compromised immune system.
-Have another disease which is not currently under control, including heart disease, uncontrolled arterial hypertension, mental illness, and other diseases.
Have either a current diagnosis or a recent history of malignant disease.
-Have allergies to certain treatments or latex.
-Are pregnant or breastfeeding.



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
Other descriptive name: 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

Trade Name: Stelara 45 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
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: 12 weeks

Main Objective: The primary objectives of this study are to assess whether 80 mg ixekizumab every 2-week (Q2W) is:
1. noninferior to ustekinumab at Week 12 in the treatment of patients with moderate to severe psoriasis, as measured by proportion of patients achieving Psoriasis Area and Severity Index (PASI) 90, and then
2. superior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis, as measured by proportion of patients achieving PASI 90

Primary end point(s): Psoriasis Area and Severity Index (PASI) 90 response (at least a (=)90% improvement in PASI score from baseline)

Secondary Objective: The secondary objectives of the study are to assess whether ixekizumab is superior to ustekinumab at the study visits in the treatment of patients with moderate-to-severe plaque psoriasis as measured by:
-proportion of patients achieving a =75% improvement in PASI (PASI 75), a =90% improvement in PASI (PASI 90), and a 100% improvement of PASI (PASI 100) from baseline
-proportion of patients with an static Physician Global Assessment (sPGA) (0,1) with at least a 2-point improvement from baseline
-proportion of patients achieving an sPGA (0) (remission)
-proportion of patients achieving dermatology-specific quality of life index (DLQI) (0,1)
-proportion of patients reaching Itch Numeric Rating Scale (NRS) responder definition (decrease of 4 points in the Itch NRS in patients with baseline score =4 points)
-change from baseline in Itch NRS
-change from baseline Skin Pain visual analog scale (VAS)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary end point(s): PASI 100,
PASI 90,
PASI 75,
Static Physician's Global Assessment (sPGA),
Nail Psoriasis Severity Index (NAPSI),
Psoriasis Scalp Severity Index (PSSI),
Palmoplantar Psoriasis Severity Index (PPASI)
Body Surface Area (BSA) percentage involvement of psoriasis,

Additionally the following Patient Reported Outcome Measures:
Itch Numeric Rating Scale (NRS),
Dermatology Life Quality Index (DLQI),
Skin Pain Visual Analog Scale (VAS),
Hospital Anxiety and Depression Scale (HADS),
Short Form (36-item) Health Survey,
Patient’s Global Assessment of Disease Severity,
Work Productivity Activity Impairment questionnaire – Psoriasis (WPAI), and
European Quality of Life – 5 Dimensions 5 Level + Bolt On (EQ 5D 5L)

Secondary ID(s)

I1F-MC-RHBS

2015-000892-28-DE

Source(s) of Monetary Support

Eli Lilly and Company