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These research study descriptions are intended for clinicians only. Information for potential study participants can be found here.
If you would like to learn more about any of the studies currently being conducted at the Skin Health Institute, please contact the nominated study coordinator.
If you have any general questions regarding the clinical trials conducted at the Institute, please feel free to contact the Clinical Trials Department at email@example.com or by phone on (03) 9623 9439.
Melanoma Research Study
Phase III Hidradenitis Suppurativa Research Study
Melanoma Research study
Melanoma surveillance photography (MSP)
What is the IMAGE study?
The IMAGE Study (Melanoma surveillance photography to improve early detection of melanoma) tests whether an advanced medical imaging technology called Melanoma Surveillance Photography (MSP), in addition to usual care, helps to improve outcomes compared to usual care alone.
What is MSP?
What is involved in melanoma surveillance photography (MSP)?
MSP combines 2D or 3D total body photography (images of the whole skin surface) with digital dermoscopy (close-up photos of individual skin lesions) to closely monitor lesions and is performed at set intervals – annually in the IMAGE study.
New technology is available that enables rapid, radiation-free total body imaging. These images can be reviewed by your usual doctor to monitor the appearance of skin lesions over time and may help to improve detection of malignant lesions – and to better differentiate malignant from benign lesions.
Who is eligible to participate?
The IMAGE study is currently recruiting patients with a diagnosis of melanoma within the last 6 months (186 days). 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.
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Phase iii Hidradenitis Suppurativa Research Study
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa.
Background and Rationale
Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease that usually presents after puberty with painful, deep-seated, inflamed lesions in the apocrine gland-bearing areas of the body. The affected areas are: inguinal, axillary, perineal and perianal as well as the submammary and/or intermammary fold in women, buttocks, mons pubis, scalp, area behind the ears and eyelids.
Bimekizumab is an engineered, humanized full-length mAb of IgG1 subclass being developed for the treatment of patients with inflammatory diseases such as PSO, psoriatic arthritis, axial spondyloarthritis, and HS. Bimekizumab has a high affinity for human IL-17A and human IL-17F, and selectively and potently inhibits the activity of both isoforms in vitro.
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS).
- Drug: Bimekizumab
- Other: Placebo
- Phase: 3
- Study Type: Interventional (Clinical Trial)
- Study Design:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
- Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
- Sexes Eligible for Study: All
- Accepts Healthy Volunteers: No
- Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative.
- Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
- Study participant must have HS lesions present in at least 2 distinct anatomic areas (e.g. left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.
- Study participant must have moderate to severe HS defined as a total of ≥5 inflammatory lesions (i.e. number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits.
- Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history.
- A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP).
- Draining tunnel count of >20 at the Baseline Visit.
- Any other active skin disease or condition (e.g. bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS).
- Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD).
- Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy.
- Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP).
- Active infection or history of certain infection(s).
- Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection.
- Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured.
- History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- Known hypersensitivity to any components of bimekizumab or comparative drugs.
- Concomitant and prior medication restrictions.
- Myocardial infarction or stroke within the 6 months prior to the Screening Visit.
- Presence of active suicidal ideation, or moderately severe major depression or severe major depression.
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening.
Participants meeting the inclusion criteria who do not meet any exclusion criteria will complete a Screening Period of 14 days up to 5 weeks; a double-blind, 48-week Treatment Period comprising a 16-week Initial Treatment Period and 32-week Maintenance Treatment Period; and a 20-week Safety Follow-up (SFU) Period following the final injection of investigational medicinal product (IMP), if they do not enter a subsequent extension study.
Participants will be randomized in a 2:2:2:1 ratio to receive 1 of 3 dose regimens of bimekizumab or placebo.
A/Prof Peter Foley
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