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Skin Health Institute

Clinical Trials - For Clinicians

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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 protected] or by phone on (03) 9623 9439.

Atopic Dermatitis 

Atopic Dermatitis

Atopic Dermatitis

Atopic Dermatitis

Nail Psoriasis

Psoriatic Arthritis

Psoriatic Arthritis

Chronic Urticaria

Melanoma Research Study

ATOPIC DERMATITIS (24 WEEKS)

Title

A Phase 2, Multicenter, Double-blind, Placebo-controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis

Background and Rationale

Atopic dermatitis (AD), also known as (atopic) eczema, is a chronic, highly symptomatic relapsing inflammatory skin disease, affecting up to 30% of children and 10% of adults. Depending on factors such as severity of skin lesions or body surface area coverage, the disease can be classified clinically as mild, moderate, or severe. Patients with AD typically have highly symptomatic skin lesions that may present acutely with erythema, exudates, papulovesicles, scales and crusts, often symmetrically distributed on the body. EDP1815 is a pharmaceutical preparation of a single strain of Prevotella histicola, originally isolated from a duodenal biopsy. The drug substance is essentially non-viable and non-replicating, with a cell viability of <0.02%. 

Purpose

The primary objective of the study is to compare the percentage of participants achieving EASI-50 at Week 16. The secondary objectives of the study are the following: 

1. To evaluate the clinical benefit of EDP815 in the treatment of atopic dermatitis.

2. To evaluate the safety and tolerability of EDP1815.

  • Condition: 
    • Atopic Dermatitis 
  • Intervention: 
    • Drug: EDP1815 
    • Other: Placebo 
  • Phase: 2 
  • 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 to 75 Years (Adult, Older Adult) 
  • Sexes Eligible for Study: All

Key Inclusion Criteria

  • Males or females aged ≥ 18 and ≤ 75 years old at the time of informed consent. 
  • A diagnosis of atopic dermatitis (AD) meeting Hanifin and Rajka criteria for AD at screening with patient- or clinician- reported disease duration of at least 6 months. 
  • Have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1: 

            i. An IGA of 2, 3 or 4 on the vIGA scale, and; 

            ii. A BSA of ≥ 5%, and; 

            iii. An EASI score of ≥ 6. 

  • All participants must agree to use a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel or ointment twice daily (or more, as needed) for at least 14 consecutive days immediately prior to randomization and must continue this treatment twice daily throughout the trial. 
  • Agrees to not increase their usual sun exposure significantly during the study.  

Key Exclusion Criteria 

  • Atopic dermatitis limited to the hands and/or feet and/or scalp. 
  • Have been in a clinical trial for EDP1815 prior to signing of ICF. 
  • History of active skin infection within 14 days prior to randomization. 
  • Evidence of dermatologic conditions that may, in the opinion of the investigator, interfere with AD evaluation or the assessment of treatment response. 
  • Previously received any biologic agent for AD and either was: a. Unresponsive to biologic agent, or b. Responsive to biologic agent and received this therapy within 3 months or 5 half-lives prior to randomization, whichever is longer. 
  • Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g. tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g. crisaborole) within 14 days prior to randomization.

Investigational Plan

The total duration of study participation will be approximately 24 weeks, including a screening phase of up to 4 weeks, a treatment period of 16 weeks, and a 4-week safety follow-up visit (at Week 20). Participants will be randomly assigned to 1 of 3 treatment groups. Within each group, participants will then be randomly assigned to receive either EDP1815 or placebo.

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]


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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).

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Title

A Phase IIb, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis.

Background and Rationale

Atopic dermatitis is a chronic/relapsing inflammatory skin disease, characterized by intense pruritus and recurrent eczematous lesions, driven by epidermal barrier dysfunction and cluster of differentiation (CD) 4+ driven inflammation, which is dominated by Th2 cytokines. KY1005 is a human anti-OX40 ligand (OX40L) immunoglobulin G (IgG) 4 monoclonal antibody (mAb) that, via blockade of the OX40/OX40L pathway, is expected to suppress T helper (Th) cell Th2-driven inflammation, as well as potentially modulating Th1, Th17 and Th22 responses. 

Purpose

The primary objective of the study is to characterize the efficacy (including dose/exposure-response) across a range of KY1005 exposures compared to placebo on the signs of AD using the Eczema Area and Severity Index (EASI) in those patients with a documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments.

  • Condition
    • Atopic Dermatitis 
  • Intervention: 
    • Drug: KY1005
    • Other: Placebo 
  • Phase: 2b 
  • 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 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All

Key Inclusion Criteria

  • Adults aged 18 to < 75 years old with AD, as defined by the American Academy of Dermatology Consensus Criteria, for 1 year or longer at Baseline.
  • EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline. 
  • IGA of 3 or 4 at Baseline. 
  • AD involvement of 10% or more of body surface area (BSA) at Baseline. 
  • Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments. 

Key Exclusion Criteria

  • Treatment with any of the following prior to first IMP administration (Baseline): 
    • systemic corticosteroids, and calcineurin inhibitors within 4 weeks; 
    • leukotriene inhibitors within 4 weeks; 
    • systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors, IFN-γ and mycophenolate mofetil within 4 weeks; 
    • targeted biologic and small molecule treatments (e.g. dupilumab, janus kinase [JAK] inhibitors) within 5 half-lives or within 12 weeks, whichever is longer; 
    • phototherapy or allergen immunotherapy within 4 weeks; 
    • any prior use of anti OX40 or anti OX40L mAb; 
    • investigational therapy for the treatment of AD or other conditions within 5 half-lives or the limit of PD effects or 3 months where the t1/2 is unknown. 
  • Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding. 
  • Skin comorbidity that would adversely affect the ability to undertake AD assessments. 

Investigational Plan

The total duration of study participation will be approximately 68 weeks, including a screening period of up to 4 weeks, a treatment period of 52 weeks, and a safety follow-up period after week 52 of 12 weeks. Four different dose regimens of KY1005 versus placebo will be evaluated in patients with AD. 

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]


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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.

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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]



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Psoriatic Arthritis (PsA) (66 weeks)

Title

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis who have had an Inadequate Response and/or an Intolerance to One Prior Anti-Tumor Necrosis Factor α Agent.

Background and Rationale

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease and the skin lesions associated with psoriasis. In addition to joint disease, PsA is also associated with a number of metabolic co-morbidities, including cardiovascular disease, diabetes and obesity as well as psychological co-morbidities, including depression and anxiety. Guselkumab (TREMFYA®, CNTO1959) is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds to the p19 protein subunit of interleukin (IL)-23 with high affinity. By binding to the p19 protein subunit of IL-23, guselkumab blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production.

Purpose

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

  • Condition
    • Psoriatic Arthritis
  • Intervention: 
    • Drug: Guselkumab
    • Other: Placebo tablet 
  • 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

Key Inclusion Criteria

  • Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening.
  • Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory.
  • Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
  • Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis.
  • Hav an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent.

Key Exclusion Criteria

  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
  • Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars). 
  • Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor. 
  • Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention. 
  • Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.
  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers. 

Investigational Plan

The total duration of study participation will be approximately 66 weeks, including a screening phase of up to 6 weeks, a blinded treatment phase of approximately 1 year that will include a placebo-controlled period followed by an active-controlled treatment phase, and a safety follow-up visit at Week 60 (approximately 12 weeks after the last intended dose of study medication).

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 9400
e: [email protected]



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PSORIATIC ARTHRITIS (PSA) (66 WEEKS)

Title

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-Naïve Participants with Active Psoriatic Arthritis Axial Disease.

Background and Rationale

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease and the skin lesions associated with psoriasis. Only 2 – 5% of patients with PsA have isolated axial disease. The risk factors for developing axial disease early in the disease course are an increased erythrocyte sedimentation rate (ESR), presence of HLA-B27, and the presence of radiographic damage to peripheral joints. Guselkumab (TREMFYA®, CNTO1959) is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds to the p19 protein subunit of interleukin (IL)-23 with high affinity. By binding to the p19 protein subunit of IL-23, guselkumab blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production.

Purpose

The primary objective of this study is to examine the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by monitoring reduction in axial symptoms and inflammation. 

  • Condition
    • Psoriatic Arthritis with axial disease
  • Intervention: 
    • Drug: Guselkumab
    • Other: Placebo tablet 
  • Phase: 4
  • 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

Key Inclusion Criteria

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening. 
  • Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD) (taken for at least 3 months or evidence of intolerance), apremilast (taken at the marketed dose for at least 3 months or evidence of intolerance), and/or nonsteroidal anti-inflammatory drug (NSAID) therapy (taken for at least 4 weeks or evidence of intolerance).
  • Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints). 
  • Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4. 
  • Have active plaque psoriasis, with at least 1 psoriatic plaque of >=2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis.

Key Exclusion Criteria

  • Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients. 
  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease. 
  • Has previously received any biologic treatment. 
  • Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor. 
  • Have received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention.

Investigational Plan

The total duration of study participation will be approximately 66 weeks, including a screening phase of up to 6 weeks. The treatment phase will include a 24-week (Week 0 to Week 24) placebo-controlled period followed by a 28-week (Week 24 to Week 48 + Week 52 final efficacy visit) blinded active-controlled treatment period. A safety follow-up visit will occur at Week 60 (approximately 12 weeks after the last intended dose of study medication).

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 9400
e: [email protected]



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CHRONIC URTICARIA (42 WEEKS)

Title

A Multinational, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizumab (XOLAIR®) in Patients With Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria who Remain Symptomatic Despite Antihistamine (H1) Treatment. 

Background and Rationale 

Chronic idiopathic urticaria (CIU), also known as chronic spontaneous urticaria (CSU), is defined as the occurrence of daily, or almost daily, wheals (red, raised areas of skin) and frequently intractable pruritus (itching) for ≥6 weeks without an obvious cause. Itch is the most concerning symptom for individuals and has the greatest impact on their quality of life. Angioedema or deep tissue swelling occurs in over 40% of patients with CIU. TEV-45779 is a humanized immunoglobulin G1 (IgG1)/kappa monoclonal antibody (mAb) directed against immunoglobulin E (IgE). TEV-45779 is being developed by the sponsor as a biosimilar candidate to omalizumab (trade name XOLAIR®).

Purpose

The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR® in patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.

  • Condition:
    • Chronic Urticaria
  •  Intervention:
    • Combination Product: TEV-45779
    • Combination Product: XOLAIR® Injection
  • 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

Eligibility 

  • Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All

Key Inclusion Criteria

  • Male or female participants aged ≥18 years and ≤75 years.
  • Diagnosis of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) refractory to H1 antihistamines for ≥3 month

Key Exclusion Criteria

  • Body weight <40 kg.
  • Chronic urticaria with clearly defined underlying etiology other than CIU/CSU.
  • Other skin disease associated with itch.
  • Evidence of parasitic infection on stool evaluation for ova and parasites.
  • History of anaphylactic shock.
  • Hypersensitivity to omalizumab or any component of the formulation.
  • Required background therapy with other than protocol-defined antihistamines.
  • Any medical condition that could jeopardize or would compromise the participant’s safety or ability to participate in this study

Investigational Plan

This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of study participation is up to 42 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
Natasha Harrison
t: 9623 9482
e: [email protected]


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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.

Eligibility Criteria

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.


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