ong term clear skin maintenance treatment optimization in patients with moderate to severe chronic plaque psoriasis: A randomized, multicenter, open-label with blinded-assessment, comparative, 52 week study to evaluate the efficacy, safety and tolerability of secukinumab 300 mg s.c.
- Conditions
- psoriasis10040790
- Registration Number
- NL-OMON42493
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Men or women * 18.
2. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
3. Moderate to severe psoriasis at Baseline as evidenced by:
* PASI * 10 and
* IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
* BSA affected by plaque-type psoriasis of * 10%.
1. History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti-interleukin (IL)12/23, or any anti-IL-17A or IL-17A receptor (IL 17AR) antibody.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes including latex hypersensitivity.
3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
6. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
7. 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 (> 5 mIU/mL).
8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during entire study or longer if
required by locally approved prescribing information (e.g. in EU 20 weeks).
9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.;See protocol for other exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to demonstrate in the patient pool of PASI 90<br /><br>responders at Week 24 that secukinumab 300 mg s.c. every 6 weeks<br /><br>treatment is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment<br /><br>with respect to maintaining a PASI 90 response rate at<br /><br>Week 52.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The key secondary objective is to demonstrate in the patient pool of PASI 75<br /><br>responders who do not reach a PASI 90 response at Week 24<br /><br>that secukinumab 300 mg s.c. administered every 2 weeks is superior to<br /><br>secukinumab 300 mg s.c. administered every 4 weeks at Week 52 based<br /><br>on the PASI 90 response rate.</p><br>