E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic arthritis
Axial spondyloarthritis |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriatic arthritis
Axial spondyloarthritis |
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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 | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071400 |
E.1.2 | Term | Axial spondyloarthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 demonstrate that the efficacy of secukinumab is superior to placebo based on the percentage of patients with resolution of Achilles tendon enthesitis as assessed by the respective subcomponent of the Leeds enthesitis index (LEI) at Week 24 in patients with active PsA and axSpA. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate the efficacy of secukinumab at Week 24 is superior to placebo based on:
-mean change of heel pain measured on a 10-point NRS
-percentage of patients with an improvement of bone marrow edema as assessed by the respective subcomponent of the PsAMRIS in the affected foot at BSL
-percentage of patients with resolution of enthesitis as assessed by the LEI
-mean change in physician's and patient`s global assessment of disease activity
-mean change in physician's and patient`s global assessment of heel enthesiopathy activity
-change from BSL in SF-36 PCS or SF-36v2
To describe (after switching from placebo to secukinumab at Week 24) the increase in:
-percentage of patients with resolution of Achilles tendon enthesitis
-mean change of heel pain in patients
Overall safety and tolerability of secukinumab
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Psoriatic arthritis patients must fulfill the following criteria:
Diagnosis of Psoriatic arthritis classified by Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by ≥1 tender joints out of 78 and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each)
- Axial Spondyloarthritis patients must fulfill the following criteria:
Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria with objective signs of inflammation at Screening (magnetic resonance imaging (MRI) with Sacroiliac joint inflammation or definite radiographic sacroilitis according to the modified New York (NY) criteria and/or abnormal high sensitivity C-Reactive Protein (hsCRP)) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0–10) at Baseline
- Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus
- Onset of heel pain ≥ 1 month up to 5 years at Baseline
- Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator`s judgement
- Patients who haven been exposed to up to two TNFα inhibitors.
Other protocol defined inclusion criteria may apply. |
|
E.4 | Principal exclusion criteria |
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process
- Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor
- Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization
-Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
- Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
- Pregnant or nursing (lactating) women
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection
Other protocol defined exclusion criteria may apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients with resolution of Achilles tendon enthesitis |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Heel pain
2) Percentage of patients with an improvement of bone marrow edema
3) Percentage of patients with resolution of enthesitis
4) Mean change in Physician`s global assessment of disease activity
5) Mean change in Patient`s global assessment of disease activity
6) Mean change in Physician`s global assessment of heel enthesiopathy activity
7) Mean change in Patient`s global assessment of heel enthesiopathy activity
8) Change in Short Form-36 Physical Component Summary (SF-36 PCS) or Short Form-36 (SF-36) v2
9) Increase in percentage of patients with resolution of Achilles tendon enthesitis after switching form placebo
10) Increase in mean change of Heel pain in patients after switching from placebo
11) Safety and tolerability |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-8: Week 24
9 + 10: Week 24 - Week 52
11: 52 weeks |
|
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |