Trial intelligence / Profile preview

Apremilast in moderate-to-severe scalp psoriasis

NCT03553433Phase 4

Key facts

Status: Unknown
Start: Jun 2018
Primary completion: Dec 2019
Countries: 1
Sponsor: University of Zurich
Modality: Small Molecules

Drugs: apremilast
Conditions: psoriasis

Overview

Phase 4, randomised, double-blind trial of apremilast in psoriasis (2 arms), sponsored by University of Zurich. Primary endpoint: Scalp Visual Analog Scale Pruritus Assessment at 16 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Verum
Apremilast 30mg bd
Placebo
Placebo Oral Tablet

Who it enrols

Adult patients with chronic plaque psoriasis (>3 months) involving >20% of the scalp, DLQI >10, and scalp pruritus VAS >50. Excludes patients with erythrodermic/guttate psoriasis, active infections, or significant psychiatric history.

Endpoints

Primary

Scalp Visual Analog Scale Pruritus Assessment16 weeks

Secondary

Scalp Visual Analog Scale Pruritus Assessment52 weeks
Body Surface Area52 weeks
Scalp Body Surface Area52 weeks
Precise Psoriasis Area and Severity Index52 weeks
Physician Global Assessment52 weeks
Scalp Physician Global Assessment52 weeks
Dermatology Life Quality Index52 weeks
Scalpdex52 weeks

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