E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
A disease that causes swollen and painful joints |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess whether ixekizumab
is superior to adalimumab at
Week 24 in the treatment of
patients with active PsA as
measured by American College of Rheumatology 50 (ACR50)
and Psoriasis Area and Severity
Index 100 (PASI 100) |
|
E.2.2 | Secondary objectives of the trial |
To assess whether ixekizumab is noninferior to adalimumab at
Week 24 in the treatment of patients with active PsA as
measured by ACR50
To assess whether ixekizumab
is superior to adalimumab at
Week 24 in the treatment of
patients with active PsA as
measured by PASI 100
To assess the effect of treatment with ixekizumab compared with adalimumab over 52 weeks as measured by various efficacy and quality of life outcomes |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
Presence of active plaque psoriasis
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
|
|
E.4 | Principal exclusion criteria |
Current or prior use of biologic agents for treatment of Ps or PsA
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
Women who are breastfeeding
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of Participants Simultaneously Achieving American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Proportion of Participants Achieving ACR50
Proportion of Participants Achieving PASI100
Change from Baseline in Tender Joint Count (TJC)
Change from Baseline in Swollen Joint Count (SJC)
Change from Baseline in Participant's Assessment of Pain VAS
Change from Baseline in Participant's Global Assessment of Disease Activity
Change from Baseline in Physician's Global Assessment of Disease Activity
Change from Baseline in C-Reactive Protein (CRP)
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Proportion of Participants Simultaneously Achieving ACR50 and PASI100
Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)
Proportion of Participants Achieving Minimal Disease Activity (MDA)
Proportion of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Change from Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified)
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline
Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline
Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline
Change from Baseline in Psoriasis Body Surface Area (BSA)
Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline
Change from Baseline in the Itch NRS
Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS)
Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L])
Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
Change from Baseline on the Treatment Satisfaction Questionnaire
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 72 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Belgium |
Canada |
Denmark |
Finland |
France |
Germany |
Hungary |
India |
Israel |
Italy |
Mexico |
Netherlands |
South Africa |
Spain |
Sweden |
Switzerland |
Ukraine |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |