A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis. (PROSE)

Novartis

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02752776

2015-003701-42 (EudraCT Number)

CAIN457A3401

Details and patient eligibility

About

Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.

Enrollment: 1,660 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women aged at least 18 years at time of Screening.
• Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
• Other protocol defined inclusion criteria may apply. Please refer to the protocol.

Exclusion criteria

• Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
• Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
• Pregnant or nursing (lactating) women
• Women of child-bearing potential unless they use effective contraception

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,660 participants in 1 patient group

Secukinumab

Experimental group

Description:

All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks.

Treatment:

Drug: Secukinumab