Clinical Trials - For Clinicians

• Condition:
  • Chronic Plaque Psoriasis
  • Moderate to Severe Nail Psoriasis
• Intervention:
  • Drug: Tildrakizumab
  • Other: Placebo
• Phase: 3
• Study Type: Interventional (Clinical Trial)
• Study Design:
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Eligibility

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult) 
• Sexes Eligible for Study: All 
• Accepts Healthy Volunteers: No 

Key Inclusion Criteria

• Participants should be 18 years or older at the time of signing the informed consent during the Screening visit.
• Participants with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by participant interview and confirmation of diagnosis through physical examination by Investigator).
• Participants must have moderate to severe nail psoriasis at Screening and Baseline, defined by:
  • mNAPSI score of ≥20
  • ViSENPsO ≥3
• Participants must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:
  • s-PGA score of at least 3
  • Body Surface Area (BSA) involvement of ≥10%
  • PASI ≥12
• Participants must be considered candidates for systemic therapy, meaning psoriasis is inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
• Participants are unlikely to conceive, as indicated by "Yes" to at least one of the following questions:
  • Participant is a male
  • Participant is a female and agrees to abstain from heterosexual activity OR use a highly effective method of contraception:
    • combined (estrogen and progestogen containing) hormonal contraception – oral, intravaginal, transdermal
    • progestogen-only hormonal contraception – oral, injectable
    • implantable progestogen-only hormonal contraception – intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion
    • vasectomized partner
    • sexual abstinence
  • Male participants with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g. condom) if not surgically sterile (i.e. vasectomy)
  • Participant is a surgically sterilized female or is documented to be postmenopausal

Key Exclusion Criteria

• Individuals who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis. 
• Individuals with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment. 
• Individuals with fungal nail infection should be excluded from the study. 
• Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating. 
• Individuals with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous (IV) antibiotics within 6 weeks prior to Screening. 
• Individuals with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
• Individuals with known history of allergy or hypersensitivity to any of the inactive ingredients of the tildrakizumab or placebo formulations. 

Investigational Plan

The total duration of study participation will be approximately 76 weeks, including a screening period of 28 days, a 52-week treatment period (28-week double-blind placebo-controlled treatment period followed by a 24-week double-blind active treatment period), and a 20-week observational follow-up period. Participants will receive either tildrakizumab or placebo via subcutaneous injection. At Week 28, those who were initially randomized to receive placebo will be switched over to receive tildrakizumab. 

Principal Investigator

A/Prof Peter Foley

For further information, please contact:

Sub Investigator
Dr Ferial Ismail
t: 9623 9464
e: [email protected]

Study Coordinator
Irina Danilovich
t: 9623 9448
e: [email protected]

Who is eligible to participate?
The IMAGE study is currently recruiting patients with a diagnosis of melanoma within the last 24 months (2 years). Your doctor will be discussing the IMAGE study with you because you have recently been diagnosed with your first melanoma and you may be eligible to participate - if other criteria are also met.

If you are:

• Aged 18 years or older at date of diagnosis of your first melanoma.
• Able to provide consent, complete questionnaires, and attend a local study site for MSP.
• Able to be referred for total body photography (you will need to undress to underwear and stand for imaging)
• Have “some” or “many” moles; and
• Currently living in Australia and have no plans to move overseas within the next 3 years.

you may be eligible to participate in the IMAGE study.

There are certain types of melanomas that will mean you are not eligible, even if all criteria above have been met. Your doctor will discuss whether they are relevant for your circumstances. This sheet provides a brief outline of the study but not all information participants will need to consider when thinking about joining the study.

For more detailed information about this study, download the Image Trial Clinicians Information and the Image Trial Patient Referral.