SUBSCRIBE TO OUR CLINICAL TRIALS NEWSLETTER
To receive weekly updates on our currently recruiting trials, fill out the following form.
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 protected] or by phone on (03) 9623 9439.
Atopic Dermatitis
Atopic Dermatitis
Nail Psoriasis
Melanoma Research Study
ATOPIC DERMATITIS (22 WEEKS)
Title
A phase 2 trial to evaluate the efficacy and safety of orally-administered LEO 152020 tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis; A randomized, triple-blind, placebo-controlled, parallel-group, international trial.
Background and Rationale
Atopic dermatitis (AD), often referred to as eczema, is a chronic, inflammatory skin disease characterized by widespread skin lesions (manifested as red, itchy, swollen, cracked, weeping lesions with crusting/scaling), intense pruritus (itch), and a general deterioration in quality of life. The medication under investigation in this study, LEO 152020, binds selectively to human H4R and has been characterized as antagonist, inhibiting both the intrinsic activity and the histamine-induced effects of the H4R. Research on H4R has shown that H4R antagonists have anti-pruritic and anti-inflammatory effects, making H4R a novel therapeutic target in AD.
Purpose
This trial will provide information on the efficacy and safety of LEO 152020 and on the exposure-response relationship of LEO 152020, allowing identification of effective dose(s).
- Condition
- Intervention:
- Drug: LEO 152020 tablet
- Other: Placebo tablet
- Phase: 2
- Study Type: Interventional (Clinical Trial)
- Study Design:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Assessor, Sponsor)
- Primary Purpose: Treatment
Eligibility
- Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
- Sexes Eligible for Study: All
Key Inclusion Criteria
- Adult, age 18 years or older at baseline.
- Diagnosis of chronic AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD ≥ 1 year prior to baseline.
- Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments, or for whom topical AD treatments are medically inadvisable.
- Body Surface Area (BSA) ≥ 5% at baseline.
- Participant agrees to apply an emollient to lesional and non-lesional skin at least twice daily for at least 7 consecutive days immediately prior to baseline.
- Women of childbearing potential and men with a female partner of childbearing potential must use 2 forms of contraception from randomization to the end of the trial.
Key Exclusion Criteria
- Concurrent skin disease at baseline which may interfere with the trial assessments.
- Active skin infection or any other clinically apparent infection at baseline.
- Previous treatment with an oral H4R antagonist (including LEO 152020) within 6 months prior to baseline.
- Previous treatment with 3 or more systemic AD treatments prior to screening.
- Systemic treatment including systemic corticosteroids known or suspected to have an effect on AD within 4 weeks or 5 half-lives prior to baseline, whichever is longer.
- Phototherapy within 4 weeks prior to baseline.
- History of lymphoproliferative disease or malignancy (except treated and recovered non-melanoma skin cancer or cervical carcinoma in situ) within 5 years prior to screening.
- Any unstable medical, surgical, psychiatric, or additional physical disorder (i.e. endocrine, gastrointestinal, hepatic, immunological, infectious, metabolic, musculoskeletal, neurological, and major physical impairment) that may affect the participant’s safety and well-being or impede their ability to complete the trial (in the investigator’s opinion).
- Women who are pregnant or lactating.
Investigational Plan
The total duration of study participation will be approximately 22 weeks, including a screening period of up to 5 weeks. Participants will receive either LEO 152020 tablet (one of three doses) or placebo tablet for 16 weeks during the treatment period. Following this, a safety follow-up visit will occur 1 week after the end of treatment visit.
Principal Investigator
A/Prof Peter Foley
For further information, please contact:
Sub Investigator
Dr Ferial Ismail
t: 9623 9464
e: [email protected]
Study Coordinator
Natasha Harrison
t: 9623 9482
e: [email protected]
Back to top
Atopic Dermatitis (33 weeks)
Title
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Dose ranging Trial to evaluate the efficacy and safety of ASLAN004 Subcutaneously Delivered ASLAN004 in Adults with Moderate-Severe Atopic Dermatitis.
Background and Rationale
Atopic dermatitis (AD) is a common, chronic, inflammatory skin disorder characterized by flaky skin lesions. Key symptoms of moderate to severe disease include severe itching, poor sleep, psycho-social dysfunction, and an impact on quality of life. ASLAN004 is a fully human monoclonal immunoglobulin G4 (IgG4) antibody that binds specifically to the IL-13Rα1 subunit, to block the signalling of both IL-4 and IL-13 through the Type II receptor. This prevents the release of pro-inflammatory cytokines, chemokines, and IgE, all of which contribute to allergic/atopic disease mechanisms.
Purpose
This clinical study is designed to evaluate dose ranging ASLAN004 versus placebo in patients who have moderate to severe AD.
- Condition:
- Intervention:
- Drug: ASLAN004
- Other: Matching Placebo
- Phase: 2b
- Study Type: Interventional (Clinical Trial)
- Study Design:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
Eligibility
- Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
- Sexes Eligible for Study: All
Key Inclusion Criteria
- Adult patients who are of or older than the legal age in participating countries, who are able to read and understand, and willing to sign the informed consent form.
- Willing and able to comply with clinic visits and study-related procedures.
- Have a clinical diagnosis of chronic atopic dermatitis (per Eichenfield revised criteria of Hanifin and Rajka) that has been present for at least 1 year before the screening visit.
- Have an IGA score of ≥3 at the screening and baseline visits.
- Have ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
- Have an EASI score ≥16 at the screening and baseline visits.
- Have a history of inadequate response to, intolerance to or contradiction to a stable (≥1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
- Have applied a stable dose of an additive, basic, bland topical emollient (moisturizer) twice daily for at least 7 days before Randomization.
Key Exclusion Criteria
- Have received previous treatment with therapeutic agents targeting ligand or receptors of IL-4 or IL-13, including but not limited to dupilumab, lebrikizumab, or tralokinumab.
- Have a known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection or positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), positive Hepatitis C antibody (HCV) at the screening visit.
- Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, etc.
- Have a history of malignancy within 5 years before Randomization with the following exceptions: patient with a history of cured in situ carcinoma of the cervix, and/or non-metastatic squamous or basal cell carcinoma of the skin are allowed.
- Pregnant or breastfeeding women.
- Patients (females and males) who are unwilling to use adequate birth control, if of reproductive potential and sexually active.
Investigational Plan
Participants who meet eligibility criteria will be randomized to receive either ASLAN004 (dose ranging) or the matching placebo, administered subcutaneously. The study is divided into 3 periods: a screening period of up to 35 days, a treatment period of 16 weeks, and a follow-up period of 8 weeks. Overall study participation will last about 33 weeks.
Principal Investigator
A/Prof Peter Foley
For further information, please contact:
Sub Investigator
Dr Ferial Ismail
t: 9623 9464
e: [email protected]
Study Coordinator
Tracy Mallet
t: 9623 9406
e: [email protected]
Back to top
Nail Psoriasis (76 weeks)
Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis (CT.gov ID: NCT03897075).
Background and Rationale
Psoriasis is a chronic inflammatory skin disorder and affects approximately 1% to 2% of people worldwide. Nail psoriasis occurs in approximately 50% of patients with plaque psoriasis and is associated with pain and discomfort, causing a significant burden to quality of life (QoL) and work function. Recent studies have demonstrated that IL-23-dependent T-helper (Th)17 cells control much of the inflammatory damage that is observed in psoriasis. Based on this rationale, several therapeutic anti-IL-23 antibodies were developed and entered into clinical studies. Tildrakizumab, an anti-IL 23p19 antibody, demonstrates comparable efficacy in psoriasis to other biological compounds in the IL-23 pathway. It has a favorable safety profile, and convenient dosing at Weeks 0, 4, and every 12 weeks after that.
Purpose
The purpose of this study is to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe nail psoriasis.
- 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]
Back to top
Melanoma Research study
Title
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 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.
Back to top