Moderate to severe plaque-type psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Conc
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. 2. Men or women of at least 18 years of age at the time of Screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. 4. Moderate to severe psoriasis as defined at Randomization by: • PASI score of 12 or greater, and • IGA mod 2011 score of 3 or greater (based on a scale of 0 – 4), and • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. 5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by • Topical treatment and/or • Phototherapy and/or • Previous systemic therapy 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Forms of psoriasis other than chronic plaque-type at Screening or Randomization. 2. Drug-induced psoriasis at Randomization. 3. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit Ultraviolet (UV) light exposure during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited. 4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. 6. Pregnant or lactating women. 7. Women of child-bearing potential. 8. Active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis (PsA) that might confound the evaluation of the benefit of secukinumab therapy. Also, underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. In addition, current severe progressive or uncontrolled diseases which renders the subject unsuitable for the trial or puts the subject at increased risk, including any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. 9. Presence of : • Significant medical problems, including but not limited to the following: uncontrolled hypertension (repeated values of systolic BP = 160 mmHg and/or diastolic BP = 95 mmHg), congestive heart failure (New York Heart Association status of class III or IV). • Serum creatinine level exceeding 2.0 mg/dL (176.8 µmol/L). • Total white blood cell (WBC) count < 2,500/µL, or platelets < 100,000/µL or neutrophils < 1,500/µL or hemoglobin < 8.5 g/dL at Screening. 10. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis. 11. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (TB) infection as defined by a positive central laboratory test result at screening. Subjects with a positive test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines prior to randomization. 12. Past medical history record or current infection with Human Immunodeficiency Virus, hepatitis B or hepatitis C prior to Randomization. 13. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of secukinumab 300 mg when administered in 2 mL auto-injector in subjects with plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo.;Secondary Objective: To demonstrate efficacy of secukinumab 300 mg 2 mL AI in subjects with plaque-type psoriasis w.r.t. PASI 90 at Week 12, compared to placebo. To assess efficacy of secukinumab 300 mg 2 mL AI in subjects with plaque-type psoriasis w.r.t. PASI score, IGA mod 2011 score, PASI 50/75/90/100 and IGA mod 2011 0 or 1 response up to Week 12 compared to placebo, and over time up to Week 52. To investigate clinical safety and tolerability of secukinumab 300 mg 2 mL AI as assessed by vital signs, clinical laboratory variables, and AE monitoring, compared to placebo. To assess subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered SIAQ and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. To investigate effects of secukinumab 300 mg 2 mL AI w.r.t. DLQI 0 or 1 achievement and DLQI changes at Week 12 compared to placebo, and over time up to Week 52.;Primary end point(s): PASI 75 response and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) PASI 90 2) PASI 50/75/90/100 and IGA mod 2011 0 or 1 3) Vital signs, lab variables, AE 4) SIAQ questionnaire and administration observation 5) DLQI 0 or 1;Timepoint(s) of evaluation of this end point: - At Week 12: 1); 2); 5) - Over time up to Week 52: 2); 3); 4); 5) | — |
Countries
Canada, Germany, Iceland, Poland, Spain, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed