Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis

Sponsor
Singapore General Hospital
Study ID
NCT04239859
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • secukinumab — BIOLOGICAL
    Secukinumab for 6 months, given at weeks 0, 1, 2, 3 and 4, then monthly till 6 months. 300mg per administration, subcutaneously.
  • Methotrexate — DRUG
    Oral tablet up to 15mg per week
  • Cyclosporin A — DRUG
    Oral capsule up to 200mg per day
  • Acitretin — DRUG
    Oral capsule up to 25mg per day

Study Details

Psoriasis (PsO) is a systemic immune disease that affect 2-4% of the population worldwide. PsO causes tremendous burden in terms of quality of life, psychological impact, disability and work productivity of affected individuals. PsO is associated with an increased risk of cardiovascular morbidities and mortality in the long term. Up to 30% of PsO patients develop psoriatic arthritis (PsA) over time causing joint deformities and further disabilities. Majority of patients with PsA developed PsO first, and arthritis develop 5-10 years after. PsA and PsO are increasingly recognized as two entities under the umbrella of psoriatic diseases. Advances in biological treatments have greatly improved the prognosis of patients with PsO. Remarkable efficacies have been demonstrated for patients with moderate to severe PsO in randomized controlled trials (RCTs). However, the high cost of biological treatment is one of the major barriers to its prescription and many patients may have limited access to these treatments. The best treatment strategy for PsO that takes into account efficacy and cost effectiveness is unknown. For instance, whether some PsO patients can stop biological treatment and be treated with non-biologic medications upon relapse, which may enhance cost effectiveness of treatment. Preliminary studies have shown that some PsO patients were able to maintain good control of disease without medications after biologics withdrawal. The patho-immunological mechanisms behind long term remission after drug withdrawal is poorly understood. Better understanding of these mechanisms in maintaining remission and relapses will advance the development of biomarkers that eventually guide development of best treatment strategies for PsO. Secukinumab targets interleukin (IL)-17a and is highly efficacious in the treatment of plague PsO with a favorable safety profile. Some patients may have the response maintained after withdrawal of secukinumab. With the proven efficacies, sustainability after withdrawal and safety profile, secukinumab could be a choice of initial treatment for patients with moderate to severe PsO. Secukinumab has been recommended as first line treatment for selected patients with moderate to severe PsO by the American Academy of Dermatology and the European S3 guidelines. However, the use of biologics as first line is limited by cost issue. Overall, real-life data on biologic treatment for moderate to severe PsO is scanty.

Key Dates

Start date
Jan 31, 2024
Status verified
Nov 2022
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Secukinumab
    Participants will be offered secukinumab as first-line systemic treatment for moderate to severe PsO. The indication for secukinumab will be equivalent to current registered indications. 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.
  • Active Comparator: Standard Care
    The management of PsO in the control arm will be the same as that in the standard care. The standard care for moderate to severe PsO in Singapore is to start either phototherapy, methotrexate, acitretin or cyclosporin A.

Primary Outcome Measure

Proportion of secukinumab treated PsO participants free of relapse after secukinumab withdrawal [ Time Frame: 12 months from secukinumab withdrawal or 18 months from baseline ]

Central Contacts

Related Studies