Psoriasis being treated with biologic therapy and has been clear/nearly clear for at least 12 months Skin and Connective Tissue Diseases
Conditions
Interventions
The PLAN-psoriasis feasibility trial is a multi-centre, assessor-blind, parallel-group, open-label, randomised controlled feasibility trial comparing the practicality and acceptability (to patients an
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (16+ years) with a diagnosis of chronic plaque psoriasis who have clinician (Physician Global Assessment) and patient (Patient Global Assessment) assessed clear/nearly clear skin at study entry on self-administered IL-23p19 inhibitor risankizumab biologic monotherapy. 2. Evidence of clear/nearly clear skin on risankizumab monotherapy for =12 months before study entry. 3. Clinician-assessed PASI =2 on study entry. 4. Capacity to provide fully informed consent to participate. 5. Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Adults receiving risankizumab primarily for psoriatic arthritis. Those receiving biologic therapy primarily for psoriasis and with controlled arthritis (no active joints or entheses) can be included. 2. Any medical condition that, in the opinion of the investigator, may compromise the safety of the participant in the trial, compromise the evaluation of the trial outcomes, or reduce the participant’s ability to participate in the trial (e.g. where loss of control of psoriasis may be a risk to an individual’s future psoriasis management such as those with a history of unstable psoriasis or generalised pustular psoriasis). 3. Concomitant immune-modifying therapy or phototherapy. 4. Currently participating in another interventional clinical trial. 5. Inability to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Practicality and acceptability is a composite outcome, forming the decision to progress to full RCT, based on a range of parameters including the following, at 12 months: 1.1. Recruitment rate measured using the proportion of eligible individuals invited to participate who are randomised (overall) in study records 1.2. Retention measured using the proportion of participants completing the 12-month follow-up visit (overall) in study records 1.3. Adherence to the treatment strategy by patients and clinicians measured using questionnaires 1.4. Acceptability of the treatment strategy to patients and clinicians measured using questionnaires and qualitative interviews with a subset of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical effectiveness is measured as follows: 1.1. Number of weeks per patient spent with ‘disease control’. ‘Disease control’ is defined as Patient Global Assessment clear/nearly clear skin with no disease worsening. It is assessed 3-monthly via the mySkin online self-report platform/app and at in-person visits (month 12 and any PIFU). ‘Disease worsening’ is defined as an assessor blind increase of at least 3 in PASI from study entry and minimum PASI 5 and/or a treatment change (biologic dose escalation, biologic switch, or adjunctive therapy). Disease worsening is assessed at in-person visits (month 12 and any PIFU). 1.2. Number of disease worsening episodes per patient (see definition of disease worsening above). 1.3. Disease severity at the end of the trial measured using assessor-blind skin assessments at the month 12 visit i.e. PASI and Physician Global Assessment. 1.4. Quality of life, measured using the Dermatology Life Quality Index (DLQI) and 5-level EQ-5D (EQ-5D-5L). 1.5. Itch, measured using the Itch Numeric Rating Scale. 1.6. Depression and anxiety, measured using the Patient Health Questionnaire (PHQ) for depression and Generalised Anxiety Disorder (GAD). 1.7. Illness perception, measured using the Brief Illness Perception Questionnaire (BIPQ). 1.8. Psoriatic arthritis disease impact (if the participant has a rheumatologist-confirmed diagnosis of psoriatic arthritis), measured using the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire. 2. Treatment/healthcare burden is measured using records as follows: 2.1. Total drug exposure, measured using the number of biologic injections administered per patient 2.2. Number of drug-free weeks per patient (post 12-week cycle) 2.3. Total number of PIFU visits 3. Safety/tolerability is measured using records as follows: 3.1. Incidence of adverse events and serious infections. 3.2. Incidence of new-onset psoriatic arthritis (screened for using the Psoriasis Epidemiology Screening Tool, PEST) or flare | — |
Countries
England, United Kingdom
Contacts
Public ContactSatveer Mahil
Outcome results
None listed