Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Plaque Psoriasis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: To evaluate the real-life effectiveness of secukinumab as first-line systemic treatment in participants with moderate to severe PsO, the investigators would recruit a pragmatic control arm. ? Intervention arm Eligible participants will be offered secukinumab as first-line systemic treatment for PsO. Standard dose of subcutaneous secukinumab for moderate to severe PsO will be given at 300 mg at weeks 0, 1, 2, 3, and 4, then monthly thereafter, for a total duration of 6 months. Secukinumab will be withdrawn after 6 months. For some participants, there may be relapse of PsO. Relapses will be managed as per standard care. ? Pragmatic control arm Eligible participants will be recruited to pragmatic control arm in these circumstances: Patient disagree to secukinumab for personal reasons. The quota for secukinumab is exhausted. The management of PsO in this pragmatic control arm will be the same as that in the standard care. Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 22 years and 90 years
- Gender
- Both males and females
Description
First, the investigators hypothesize that a proportion of participants with moderate to severe PsO may sustain good outcomes when a short course of secukinumab is withdrawn. Second, the investigators hypothesize that they can identify the perturbations in the architecture of the immunome which are p...
First, the investigators hypothesize that a proportion of participants with moderate to severe PsO may sustain good outcomes when a short course of secukinumab is withdrawn. Second, the investigators hypothesize that they can identify the perturbations in the architecture of the immunome which are pathogenic, and to discriminate such perturbations based on treatment and clinical responses, thus distilling therapeutics and diagnostics signatures. Therefore, the objectives of this study are as follow: Specific aim 1: To describe the clinical course, sustained good outcomes, relapse rate, time to relapse and quality of life in PsO participants who stopped a 6-month short course treatment of secukinumab, till the end of 2-years. Specific aim 2: To identify the genomic and immunomics signatures in skin biopsies and blood in PsO participants who has good outcomes (PASI 75) at 6 months, comparing treatment vs pragmatic control. Specific aim 3: To identify the genomic and immunomics signatures in skin biopsies and blood in PsO participants who sustained good outcomes at 1 year after stopping secukinumab, compared to those relapsed.
Tracking Information
- NCT #
- NCT04239859
- Collaborators
- Translational Immunology Institute
- Investigators
- Principal Investigator: Ying Ying Leung, MD Singapore General Hospital
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