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23 March 2022

Opportunity for adolescent patients with psoriasis to take part in the OptIMMize-1 trial

The trial will compare the treatment efficacy and safety of two biologic therapies, Risankizumab (Skyrizi) and Ustekinumab (Stelara).

This is an opportunity for 12-17 year old patients with moderate to severe plaque psoriasis. The trial, sponsored by the pharmaceutical company, AbbVie, compares the treatment efficacy and safety of Risankizumab (Skyrizi) vs Ustekinumab (Stelara), two biologic therapies. All participants are guaranteed active treatment, regardless of whether they have had systemic therapy before.

Recruitment criteria (list not exclusive):

  • Aged between 12 to < 18 years at the time of enrolment
  • Have had a diagnosis of chronic plaque psoriasis for at least 6 months
  • Have moderate to severe psoriasis, defined as ≥ 10% Body Surface Area (BSA) psoriasis involvement with a static Physician’s Global Assessment (sPGA) score of ≥ 3, or Psoriasis Area and Severity Index (PASI) ≥ 12

  • No history of:

  • Erythrodermic psoriasis, generalised or localised pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis;
  • Active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
  • Clinically significant drug or alcohol abuse within the last 6 months;
  • An allergic reaction or hypersensitivity to a biologic agent or its excipients;
  • A latex allergy;
  • An organ transplant that requires continued immunosuppression;
  • Any malignancy except for successfully treated non-melanoma skin cancer or localised carcinoma in situ of the cervix.

  • No evidence of:

  • Hepatitis B (HB) (hepatitis B virus [HBV]) or hepatitis C (hepatitis C virus [HCV]) infection;
  • Human immunodeficiency virus (HIV), defined as confirmed positive anti-HIV antibody (HIV Ab) test;
  • Genetic deficiency in IL-12/IL-23;

  • The following centres are open for recruitment into the study (please email the investigators directly):

  • West Ambulatory Care Hospital, Glasgow: Areti.Makrygeorgou@ggc.scot.nhs.uk
  • Frimley Park Hospital, Surrey: sara.sherif@nhs.net
  • Royal Devon and Exeter Hospital, Devon: naomi.goldstraw@nhs.net
  • Derriford Hospital, Plymouth: thurein.newin@nhs.net
  • Guy’s and St Thomas’ NHS Foundation Trust, London: please email Eva.Hilger@gstt.nhs.uk or call 07917217601

  • Dr Wedad Abdelrahman, Chief Investigator (wedad.abdelrahman@gstt.nhs.uk)
    Prof Carsten Flohr, Study Investigator (carsten.flohr@kcl.ac.uk)
    Consultant Paediatric Dermatologists

    St John’s Institute of Dermatology,
    Guy’s & St Thomas’ NHS Foundation Trust

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