E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the skin |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI (Simplified Psoriasis Index). This index comprises 3 components: severity (s), psychosocial (p) and intervention, (i) evaluated by both the physician (proSPI) and the patient (self assessed: saSPI).
Only the severity (s) component will be evaluated for the primary objective (both proSPI (s) and saSPI (s)). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis will be analyzed.
|
|
E.2.2 | Secondary objectives of the trial |
• To assess PASI (weekly from week 0 to 4 then every 4 to 8 weeks until Week 56).
• To evaluate correlation between PASI and proSPI (s).
• To assess each component of proSPI (s, p and i) over time (weekly from Week 0 to 4 then every 4 to 8weeks until Week 56).
• To assess each component of saSPI (s, p and i) over time (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56).
• To assess DLQI over time (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56).
• To assess self-administered PASI (SA-PASI) (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56).
• To assess pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56).
• To evaluate correlation between proSPI (for each component: s, p and i) and DLQI
• To evaluate correlation between proSPI (for components p and i) and PASI
• To evaluate safety.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients aged ≥ 18 years old at the Screening visit.
2. Patients with a history of chronic moderate to severe plaque psoriasis (PASI ≥ 12, BSA ≥ 10 and IGA mod 2011 ≥ 3) for at least 6 months.
3. Patients eligible for treatment with a biotherapy i.e. not adequately controlled with at least two conventional systemic therapies (including methotrexate, cyclosporine, phototherapy).
4. Patients able to understand and communicate with the investigator and comply with the requirements of the study (including administration of s.c. injections at home), capable of and willing to complete several questionnaires at visits, and must provide written, signed and dated informed consent before any study related activity is performed.
|
|
E.4 | Principal exclusion criteria |
1. Patients with a history of hypersensitivity to the study drug or to drugs of a similar chemical class.
2. Patients with recent (previous 6 months) or planned vaccination with live virus.
3. Patient participation in another clinical study during the 4 weeks prior to study drug initiation or 5 half-lives (whichever is the longest).
4. Patients taking other drugs for psoriasis (e.g. corticosteroids, vitamin D analogs, pimecrolimus, retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, α-hydroxy or fruit acids).
5. Patients suffering from a skin condition other than moderate to severe plaque psoriasis that may confound psoriasis evaluation, or other inflammatory disease.
6. Patients suffering from drug-induced psoriasis (e.g. new onset or current exacerbation by beta-blockers, calcium channel inhibitors, or lithium), as judged by investigator.
7. Patients with underlying condition(s) (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiovascular (eg: heart failure NYHA class III or IV, unstable angina….), infectious, gastrointestinal or psychiatric) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy).
8. Patients with previous treatment with any agent targeting Interleukin (IL)-17 directly or IL-17 receptor (e.g. secukinumab, ixekizumab, or brodalumab).
9. Patients refusing to limit sunlight or Ultraviolet (UV) light exposure.
10. Patients unwilling to be subjected to repeated s.c. injections and venipuncture.
11. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (TB) infection as defined by a positive or indeterminate QuantiFERON TB Gold test (QFT) at screening visit. Patients with a positive QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) completed at least 12 weeks prior to study drug initiation establishes conclusively that the patient has no evidence of active tuberculosis. If the presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to guidelines for at least 4 weeks prior to study drug initiation.
12. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for skin Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non invasive malignant colon polyps that have been removed).
13. Pregnant or nursing (lactating) women (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test).
14. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment. 15. Active systemic infections during the 2 weeks prior to study drug initiation (exception: common cold) or any infection that reoccurs on a regular basis; investigator discretion should be used regarding patients who have traveled or resided in areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis and for patients with underlying conditions that may predispose them to infection, such as advanced or inadequately controlled diabetes.
16. Past medical history record of, or current infection at study drug initation with, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
17. Chest X-ray, computerized tomography (CT scan), or Magnetic Resonance Imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 12 weeks prior to investigational drug administration, and evaluated by a qualified physician.
18. Serum creatinine level exceeding 2.0 mg/dL (176.8 μmol/L) at screening visit.
19. Total white blood cell (WBC) count <2 500/μL, platelets <100 000/μL, neutrophils <1 500/μL or hemoglobin <8.5 g/dL at screening visit.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the change from baseline of proSPI (s) and saSPI (s)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1/ To evaluate the change from baseline of PASI
2/ To evaluate correlation between PASI and proSPI(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and over time till Week 56 |
|
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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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 | 17 |
E.8.5 | The trial involves multiple Member States | No |
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
|
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | |