Therapeutic Drug Monitoring of Secukinumab in Psoriasis Patients.
NCT04080661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2024-09-19
Summary
Biologics such as secukinumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of secukinumab and determine the therapeutic window of secukinumab in psoriasis patients.
Conditions
- Psoriasis Vulgaris
Interventions
- PROCEDURE
-
Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of secukinumab.
- OTHER
-
Patient questionnaires
The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.
Sponsors & Collaborators
-
KU Leuven
collaborator OTHER -
University Ghent
collaborator OTHER -
University Hospital, Ghent
lead OTHER
Principal Investigators
-
Jo Lambert, Prof. · University Ghent
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-22
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Belgium
Study Locations
More Related Trials
-
Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
NCT02559622 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Tapering Study of Adalimumab in Psoriasis
NCT04028713 ·Status: TERMINATED ·Phase: PHASE4
-
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
NCT02690701 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
NCT03066609 ·Status: COMPLETED ·Phase: PHASE3
-
An Explorative Psoriasis Biomarker Study
NCT04394936 ·Status: TERMINATED ·Phase: NA
-
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
NCT02362789 ·Status: COMPLETED ·Phase: PHASE3
-
Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients
NCT02147600 ·Status: COMPLETED
-
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
NCT02595970 ·Status: COMPLETED ·Phase: PHASE3
-
Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
NCT06666114 ·Status: COMPLETED
-
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
NCT01412944 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
NCT03668613 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo
NCT02798211 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis
NCT05125679 ·Status: TERMINATED ·Phase: PHASE4
-
Study of Secukinumab With 2 mL Pre-filled Syringes
NCT02748863 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis
NCT03020199 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
NCT02826603 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
NCT04209205 ·Status: COMPLETED ·Phase: PHASE3
-
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
NCT01555125 ·Status: COMPLETED ·Phase: PHASE3
-
Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis
NCT02474069 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
NCT04632927 ·Status: COMPLETED ·Phase: PHASE3
-
Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis
NCT03828643 ·Status: COMPLETED
-
Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis
NCT03504852 ·Status: COMPLETED ·Phase: PHASE3
-
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
NCT01636687 ·Status: COMPLETED ·Phase: PHASE3
-
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
NCT02394561 ·Status: COMPLETED ·Phase: PHASE3
-
A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated
NCT05683054 ·Status: COMPLETED ·Phase: PHASE4