A multicenter double blind, placebo-controlled randomized pilot study evaluating efficacy and safety of ETN in patients with moderate to severe plaque psoriasis after cessation of ciclosporin therapy "Estudio piloto aleatorizado, multicéntrico, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de ETN en pacientes con psoriasis en placas moderada o intensa tras la interrupción del tratamiento con ciclosporina"

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004454-25-ES

Enrollment

136

Registered

2007-01-24

Start date

2007-04-24

Completion date

Unknown

Last updated

2021-10-08

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

Conditions

Moderate to severe chronic plaque psoriasis. Psoriasis en placas moderada a intensa

Interventions

Trade Name: Enbrel Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years; BSA>10% or PASI>10; Negative result of b-HCG; Sexually active men and women participating in the study must use a medically acceptable form of contraception that needs to be continued for 3 months following discontinuation of ciclosporin; Ability to inject study drug subcutaneously; Ability to store injectable test article at 2°C to 8°C. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Evidence of skin conditions (eg, eczema) other than psoriasis; PUVA; Ciclosporin, acitretin, alefacept; efalizumab, infliximab, anakinra or any DMARD within 90 days of screening; UVB topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days of screening; Any TNF-inhibitor, including etanercept; Serious infection; Abnormal hematology or chemistry; Receipt of any live (attenuated) vaccine within 4 weeks prior to randomization; Pregnant or breast-feeding women; Significant concurrent medical conditions at the time of screening.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the sustained efficacy and safety of etancercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.;Secondary Objective: ;Primary end point(s): Evaluation of change in PASI score from randomization to week 24 (week 18 of ETN monotherapy). PASI Area Under the Curve (AUC) between randomization and week 24; Change in PGA score; % Relapse; % improvement in PASI; Change in DLQI	—

Measure

Time frame

Main Objective: To demonstrate the sustained efficacy and safety of etancercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.;Secondary Objective: ;Primary end point(s): Evaluation of change in PASI score from randomization to week 24 (week 18 of ETN monotherapy). PASI Area Under the Curve (AUC) between randomization and week 24; Change in PGA score; % Relapse; % improvement in PASI; Change in DLQI

—

Countries

Germany, Greece, Italy, Malta, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026