Efficacy, safety and tolerability assessment of secukinumab 300 mg s.c. optimization in patients with moderate to severe chronic plaque psoriasis.

Phase 1

• Conditions: Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005339-15-IT
• Lead Sponsor: OVARTIS FARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-08
• Study Start: 2018-02-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1647

Inclusion Criteria

1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
2. 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%.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1422
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 158

Exclusion Criteria

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.
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 dosing of study drug and for
16 weeks after stopping study drug.
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.
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified