Outcomes With Treatment and Withdraw of Ixekizumab 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 ixekizumab 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 ixekizumab as first-line systemic treatment for PsO. Standard dose of subcutaneous ixekizumab for moderate to severe PsO will be given at 160 mg at week 0, followed by ixekizumab 80mg at weeks 2, 4, 6, 8, 10 and 12, then 4 weekly thereafter, for a total duration of 6 months. Ixekizumab will be withdrawn after 6 months.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 ixekizumab for personal reasons. The quota for ixekizumab 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of patients with moderate to severe PsO may sustain reasonable good outcomes when a short course of ixekizumab is withdrawn. Second, the investigators hypothesize that the investigators can identify the perturbations in the architecture of the i...
First, the investigators hypothesize that a proportion of patients with moderate to severe PsO may sustain reasonable good outcomes when a short course of ixekizumab is withdrawn. Second, the investigators hypothesize that the investigators 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 theragnostic signatures. Therefore, the objectives of the 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 patients who stopped a 6-month short course treatment of ixekizumab, till the end of 2-years. Specific aim 2: To identify the genomic and immunomic signatures in skin biopsies and blood in PsO patients who has good outcomes (PASI 75) at 6 months, comparing treatment vs pragmatic control. Specific aim 3: To identify the genomic and immunomic signatures in skin biopsies and blood in PsO patients who sustained good outcomes at 1 year after stopping ixekizumab, compared to those relapsed.
Tracking Information
- NCT #
- NCT04537689
- Collaborators
- Translational Immunology Institute
- Investigators
- Principal Investigator: Ying Ying Leung, MD Singapore General Hospital
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