PLAN-psoriasis feasibility trial
- Conditions
- Psoriasis being treated with biologic therapy and has been clear/nearly clear for at least 12 monthsSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN17922845
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 90
1. Adults (16+) 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1.1. Recruitment rate measured using the proportion of eligible individuals invited to participate who are randomised (overall) in study records<br>1.2. Retention measured using the proportion of participants completing the 12-month follow-up visit (overall) in study records<br>1.3. Adherence to the treatment strategy by patients and clinicians measured using questionnaires<br>1.4. Acceptability of the treatment strategy to patients and clinicians measured using questionnaires and qualitative interviews with a subset of participants
- Secondary Outcome Measures
Name Time Method