Clinical Trials - For Clinicians

• 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]

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]

• 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]

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]

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]

• 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]

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.