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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)

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43019
Enrollment
20
Registered
2016-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

plaque psoriasis psoriasis vulgaris

Interventions

Secukinumab (AIN457) 300 mg Narrow-band UVB

Sponsors

TFS Trial Form Support BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Aged 18 to 40 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To demonstrate that early treatment with secukinumab 300 mg s.c. (Arm A1) is superior to standard of care treatment with nb-UVB (Arm B1) in patients with new-onset moderate to severe psoriasis with respect to patients achieving * 90% improvement (reduction) in psoriasis area and severity index (PASI 90) response at Week 52.—

Secondary

MeasureTime frame
To evaluate the superiority of early treatment with secukinumab (Arm A1) versus nb-UVB (Arm B1) based on the proportion of all randomized patients who achieve at least PASI 90 at Week 104.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)