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Skin Health Institute

Clinical Trials - For Clinicians

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 trials@skinhealthinstitute.org.au or by phone on (03) 9623 9439.

Phase I Atopic Dermatitis

Phase II Atopic Dermatitis

Phase IIIb Atopic Dermatitis

Phase III Atopic Dermatitis

Phase II Alopecia Areata

Phase II Onychomycosis

Phase IIa Hidradenitis Suppurativa Research Study

Phase III Hidradenitis Suppurativa Research Study

Phase i Atopic Dermatitis Research study

Title

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of 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 multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate to severe AD.


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Phase II Atopic Dermatitis Research Study

Title

A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects with Moderate-to-severe Atopic Dermatitis.

Purpose

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 (a monoclonal antibody) for the treatment of adult subjects with atopic dermatitis. 

  • Condition:
    • Atopic Dermatitis
  • Intervention:
    • Drug: MEDI3506
    • Other: Placebo
  • Phase: 2
  • 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
  • Accepts Healthy Volunteers: No

 

Inclusion Criteria

  • Age 18 to 75 years inclusive at the time of consent
  • Body mass index between 19.0 and 40.0 kg/m2 inclusive
  • Documented history of chronic AD, for at least 1 year prior to screening Visit 1
  • Meets at minimum 1 of the criteria, as follows:
    • History of inadequate response to topical medications for AD
    • Subject intolerance to treatment with topical medications for AD, or
    • Topical medications are otherwise medically inadvisable
  • AD that affects ≥ 10% of the body surface area (BSA)
  • An EASI score of ≥ 16
  • An IGA score of ≥ 3

Exclusion Criteria

  • Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
  • Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
  • Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
  • Known active allergic or irritant contact dermatitis.

Investigational Plan

Participants will be enrolled in this study for approximately 6.8 months (27 weeks), comprising a screening and topical corticosteroid (TCS)/topical calcineurin inhibitor (TCI) wash out period of up to 3 weeks, a 16-week treatment period, and an 8-week follow-up period.

Participants will receive one of 3 dose regimens of MEDI3506 SC (subcutaneous injection), or one of 2 dose regimens of placebo SC, every 4 weeks (Q4W) for a total of 4 doses with the final dose at Week 12. Individuals will be required to apply moisturizers twice daily throughout the treatment period.


Principal Investigator

A/Prof Peter Foley

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Phase IIIb Atopic dermatitis research study

Title

A Phase IIIb Randomized, Double-Blind, Double-Dummy, Active Controlled Multi-Center Study Assessing The Efficacy and Safety of Abrocitinib Compared With Dupilumab in Adult Participants on Background Topical Therapy With Moderate to Severe Atopic Dermatitis.

Background and Rationale

Atopic dermatitis (AD), also known as atopic eczema, is a common, chronic, inflammatory skin disorder characterized by flaky skin lesions, intense pruritus, and a general deterioration in quality of life. Abrocitinib (formerly known as PF-04965842) is an orally bioavailable small molecule that selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site. The selective inhibition of JAK1 will lead to modulation of multiple cytokine pathways involved in the pathophysiology of AD.

Purpose

To assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD.


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Phase III Atopic dermatitis 

Title

 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis. 

Background and Rationale

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus (itching), xerosis (skin dryness), and eczematous lesions whose features include erythema, infiltration/papulation, oozing with crusting, excoriations, and lichenification. Nemolizumab is a monoclonal antibody against interleukin 31 receptor A (IL-31 RA), which has been implicated in the inflammation of AD and is involved in the pathogenesis of pruritus. 

Purpose

To assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis (AD).

  • Condition:
    • Moderate-to-Severe Atopic Dermatitis
  • Intervention:
    • Drug: Nemolizumab
    • 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

Eligibility

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult). 
Note: Skin Health Institute is not enrolling adolescents, only those aged 18+.
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria

  • Male or female subjects aged ≥ 18 years at the screening visit
  • Chronic AD that has been documented for at least 2 years
  • EASI score ≥ 16
  • IGA score ≥ 3
  • AD involvement ≥ 10% of BSA
  • Documented recent history of inadequate response to topical medications (TCS with or without TCI).
  • Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Exclusion Criteria

  • Body weight < 30 kg
  • Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
  • Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week.
  • History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g. monoclonal antibody).
  • Any clinically significant issue, based on investigator judgement.

Investigational Plan

The study consists of 4 periods: screening (including run-in), initial treatment, maintenance, and follow-up. Length of study participation will vary per person as well as the number of visits to the study centre. Subjects will be randomized to receive either nemolizumab (CD14152) or placebo. 


Principal Investigator

A/Prof Peter Foley


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Phase II ALOPECIA AREATA Research study

Title

A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 tablets in Adult Patients with Alopecia Areata

Background and Rationale

Alopecia Areata (AA) is an autoimmune disease where body T cells attack the hair follicles resulting in transient non-scarring hair loss, which may last for a few weeks to decades.  The hair loss can affect any areas of the body where hair follicles exist.  However, it is most noticeable at the scalp, and eyebrow, because of their visible location.

SHR0302 is a selective JAK1 inhibitor administered orally.  Selective inhibition of JAK1 can modulate multiple cytokine signaling pathways in AA pathogenesis, such as IL-15, and IFN-γ.  The high selectivity of SHR0302 to JAK1 also makes it a favorable candidate from a benefit-risk safety perspective.

Purpose

This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

  • Condition:
    • Alopecia Areata
  • Intervention:
    • Drug: SHR0302
    • Other: Placebo
  • Phase: 2
  • 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 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria

  • Male or female, between 18-65 years of age (both inclusive)
  • Must have moderate to severe alopecia areata
  • Involvement: 25% or greater scalp hair loss

Exclusion Criteria

  • Other types of alopecia or other diseases that can cause hair loss
  • Other scalp diseases that could interfere with assessment of hair loss/regrowth
  • Any previous use of any Janus kinase (JAK) inhibitor

Investigational Plan

This study is conducted over a 24-week treatment period.  Three active doses of oral SHR0302 are compared to placebo, and the improvement in hair regrowth among AA patients will be assessed using the Severity of Alopecia Tool scoring method.


Principal Investigator

A/Prof Peter Foley


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PHASE II ONYCHOMYCOSIS RESEARCH STUDY

Title

A Phase II, Randomized, Double-blind, Vehicle-controlled Study to Investigate the Efficacy, Safety, and Tolerability of HXP124 in Patients with Mild to Moderate Onychomycosis.

Background and Rationale

Onychomycosis, also known as tinea unguium, is a fungal infection that accounts for approximately 50% of all nail disorders. This infection often involves the great toenail and may affect one or more toenails or fingernails. It is characterized by inflammation around the nail fold and discolouration of the nearby nail. It can be quite painful to touch. Onychomycosis often results from untreated tinea pedis (feet) or tinea manum (hand) or may follow a nail injury. HXP124 is a plant defensin topical preparation which has potent antifungal properties. 

Purpose

To evaluate the safety and tolerability of 20mg/ml topical HXP124 in treated participants with mild to moderate onychomycosis of the target great toenail.

  • Condition:
    • Mild to Moderate Onychomycosis of the great toenail
  • Intervention:
    • Drug: HXP124
  • Phase: 2
  • Study Type: Interventional (Clinical Trial) 
  • Study Design:
      • Allocation: Randomized
      • Intervention Model: Double-Blind, Vehicle controlled
      • Primary Purpose: Treatment

Eligibility

    • Ages Eligible for Study: 18 Years and older up to age 65 (Adult, Older Adult)
    • Sexes Eligible for Study: All

Inclusion Criteria

    • Male or female participants 18-65 years of age (inclusive) in otherwise good health based on past medical history, physical examination, vital signs, ECG and laboratory tests at screening, as determined by the investigator.
    • Confirmed diagnosis of onychomycosis by positive mycological microscopic stain and culture examination.
    • Combined thickness of the distal plate at the associated hyperkeratotic nail bed is ≤ 3 mm at screening.
    • Clear nail growth of ≤ 3 mm from the proximal nail fold and evidence of nail growth.

Exclusion Criteria

    • Presence of dermatophytoma in the target great toenail
    • Lunula (matrix) involvement or exclusively lateral disease in the target great toenail
    • Presence of hyperkeratotic/moccasin-type tinea pedis (athletes’ foot) at screening or baseline visits
    • Presence of more than 6 infected toenails and/or any infected fingernails
    • Presence of any other disease or condition that might cause nail abnormalities or interfere with the evaluation of the study drug
    • Pregnant or lactating females at screening to plans to become pregnant or breastfeed from the time of enrolment until 30 days after the last application of study drug.

Investigational Plan

Once-daily application for two treatment periods of 6 weeks (2 x 42 days; Cohort 1), once-daily application for two treatment periods of 6 weeks (2 x 42 days) plus once‑weekly maintenance dosing for 23 weeks (161 days; Cohort 2), and once-daily application for five treatment periods of 6 weeks (5 x 42 days) plus one treatment period of 1 week (1 x 7 days; Cohort 3).


Principal Investigator

A/Prof Peter Foley



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Phase iia hidradenitis suppurativa research study

Title

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 16-Week Study Evaluating the Safety and Efficacy of PF-06650833, PF-0670084 and PF-06826647 in Adults 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 in decreasing order of frequency: 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. Currently, adalimumab is the only approved medical treatment for moderate to severe HS. As such, this study will look at PF-06650833, an IL-1 receptor-associated kinase 4 (IRAK4) inhibitor, PF-06700841, a dual inhibitor of human tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1), and PF-06826647, a potent TYK2 inhibitor, in patients with moderate to severe HS. Since the pathophysiology of HS is not defined completely, it is uncertain which of these three disease targets and pathways would be of more relevance for the treatment of patients with HS.

Purpose

The objectives of the current study are to evaluate the efficacy, safety and tolerability of 3 kinase inhibitors (PF-06650833, PF-06700841 and PF-06826647) in participants with moderate to severe HS.

  • Condition:
    • Acne Inversa (Hidradenitis Suppurativa)
  • Intervention:
    • Drug: PF-06650833
    • Drug: PF-06700841
    • Drug: PF-06826647
    • Drug: Placebo
  • Phase: 2
  • Study Type: Interventional (Clinical Trial) 
  • Study Design:
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
    • Primary Purpose: Treatment

Eligibility:

  • Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Male or female participants, between 18-75 years of age.
  • Diagnosis of moderate to severe hidradenitis suppurativa for at least one year.
  • HS lesions present in at least 2 distinct areas of the body, with at least 4 inflammatory nodules or abscesses present.
  • Inadequate response to at least a 4-week (28 day) trial of an oral antibiotic for the treatment of HS.
  • Participants must agree to use topical antiseptics daily, during study participation.

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) or positive HIV serology at screening.
  • Infected with hepatitis B or hepatitis C viruses.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Investigational Plan:

The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16-week Dosing Period and a 4-week Follow-up Period.

Participants are randomly assigned to receive 1 of 6 treatments. One oral dose level of each PF-06650833, PF-06700841 and PF-06826647 or matching placebo in a 3:1 ratio, will be investigated.


Principal Investigator:

A/Prof Peter Foley


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Phase iii Hidradenitis Suppurativa Research Study

Title

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 high affinity for human IL-17A and human IL-17F, and selectively and potently inhibits the activity of both isoforms in vitro.

Purpose

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS).


  • Condition:
    • Hidradenitis Suppurativa
  • Intervention:
    • 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

Eligibility:

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

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Investigational Plan:

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.


Principal Investigator:

A/Prof Peter Foley


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