Study of efficacy and safety of secukinumab 1 mL pre-filled syringe (300 mg) in subjects of body weight 90 kg or higher with moderate to severe plaque psoriasis.
- Conditions
- Moderate to severe chronic plaque-type psoriasisMedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-004620-60-HU
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
1. Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
2. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study.
3. Men or women at least 18 years of age at time of screening.
4. Body weight of =90 kg at the time of randomization.
5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
6. Moderate to severe psoriasis as defined at randomization by:
• Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
• IGA mod 2011 score of 3 or greater (based on a static scale of 0 – 4), and
• Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
7. 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 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to as per protocol Table 5-1. Subjects not willing to limit UV light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited.
3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting interleukin (IL-17) or the IL-17 receptor.
4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
5. Pregnant or nursing (lactating) women
6. 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 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).
7. History of hypersensitivity to any of the study drug constituents.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare efficacy, safety and tolerability of secukinumab 300 mg every 2 weeks to secukinumab 300 mg every 4 weeks in subjects with moderate to severe chronic plaque-type psoriasis and body weight of 90 kg or higher, and to explore the option of exposure escalation for those subjects who do not achieve the therapeutic goal at the dose regimen of 300 mg every 4 weeks. ;Secondary Objective: To demonstrate the efficacy of secukinumab 300 mg every 2 weeks in comparison to secukinumab 300 mg every 4 weeks with respect to Investigator's Global Assessment (IGA) mod 2011 0 or 1 response at Week 16.<br>To investigate the clinical safety and tolerability of secukinumab 300 mg every 2 weeks in comparison to 300 mg every 4 weeks. ;Primary end point(s): PASI 90;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): IGA mod 2011 0 or 1 response <br><br>Clinical safety and tolerability ;Timepoint(s) of evaluation of this end point: Week 16<br><br>Week 52