EUCTR2015-002423-26-PL
Active, not recruiting
Phase 1
A randomized, multicenter Study to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 Weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow band UVB (STEPin study) - STEPin
DrugsCOSENTYX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 196
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Aged 18 to 50 years inclusive
- •\* moderate to severe plaque psoriasis with either new onset or lasting for at least 5 years.
- •Additional inclusion criteria may apply , please refer to the protocol.
- •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 196
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\* Forms of psoriasis other than plaque\-type (e.g., pustular, erythrodermic, guttate, light sensitive, drug induced)
- •\* Ongoing use of prohibited treatments
- •\* Pregnant or nursing (lactating) women
- •\* Women of child\-bearing potential not willing to use contraception
- •\*Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab therapy
- •Additional exclusion criteria may apply , please refer to the protocol.
Outcomes
Primary Outcomes
Not specified
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