Dialog Box

Skin Health Institute

Clinical Trials - For Clinicians

Important COVID-19 Update

In response to the decision made by the Victorian government to place Melbourne Metropolitan area under Stage 4 restrictions, the Skin Health Institute has temporarily suspended recruitment. During this time, we will continue to pre-screen any patients that are interested in participating in a clinical trial. 

Please contact the trials manager Sarah Chivers at schivers@skinhealthinstitute.org.au for further information.



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.


Alopecia Areata

Onychomycosis

Placebo-Controlled Alopecia Areata

Scalp Psoriasis Research Study

Hidradenitis Suppurativa Research Study - 1

Hidradenitis Suppurativa Research Study - 2

Hidradenitis Suppurativa Research Study - 3


RESEARCH STUDY FOR ALOPECIA AREATA

Title

A Phase 3 Open-Label, Multi-Center, Long-Term Study Investigating the Safety and Efficacy of PF-06651600 in Adult and Adolescent Participants with Alopecia Areata.

Background and Rationale

Alopecia areata (AA) is a chronic relapsing T-cell mediated autoimmune disorder characterized by non-scarring hair loss affecting children and adults across all ages, races, and sexes. PF-06651600 is an orally bioavailable, small molecule that is currently being investigated in patients with AA. Based on the mechanism of action of PF-06651600, this investigational product is expected to inhibit the signaling of multiple soluble cytokines and signaling pathways contributing to the AA pathogenesis.

Purpose

This study is specifically designed to evaluate the long-term safety, tolerability and efficacy of PF-06651600 in adults and adolescents with AA. Eligible participants from the prior studies B7931005 and B7981015 will have an opportunity to enrol, as well as individuals who have not previously participated in either of these studies.

  • Condition:
    • Alopecia Areata
  • Intervention:
    • Drug: PF-06651600
  • Phase: 3
  • Study Type: Interventional (Clinical Trial) 
  • Study Design:
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
    • 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

 

Inclusion Criteria

  • Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed. 
  • >=25% hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis. 
  • No evidence of terminal hair regrowth within 6 months. 
  • Current episode of hair loss <=10 years. 

Exclusion Criteria

  • Other types of diseases that can cause hair loss or that could interfere with assessment of hair loss/regrowth.
  • Participants with shaved heads must not enter the study until hair has grown back and is considered stable by the investigator.
Note: Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit.

Investigational Plan

Participants enrolling from B7931005 and B7981015 who received study intervention in one of these studies will receive open-label PF-06651600 50 mg QD. De novo participants (i.e. those who have not previously received study intervention in B7931005 or B7981015) will receive open-label PF-06651600 200 mg QD for 4 weeks followed by open-label 50 mg PF-06651600 QD. Overall study participation will last approximately 26 months.


Principal Investigator

A/Prof Peter Foley


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RESEARCH STUDY FOR ONYCHOMYCOSIS

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:
    • 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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RESEARCH STUDY FOR ALOPECIA AREATA - 28 WEEKS

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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scalp psoriasis research study

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 Plaque Psoriasis of the Scalp.

Background and Rationale

Psoriasis is a chronic inflammatory skin disorder, characterized primarily by erythematous scaly plaques, that affects approximately 1% to 2% of people worldwide. Of those affected by psoriasis, up to 80% will have involvement of the scalp. Scalp psoriasis may occur in isolation or in conjunction with other forms of psoriasis and is characterized by red, thickened plaques with silver-white scale, either contained within the hairline, or extending onto the forehead, ears, and posterior neck. Tildrakizumab, an anti-IL 23p19 antibody, demonstrates comparable efficacy in psoriasis to other biological compounds in the IL-23 pathway.

Purpose

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe plaque psoriasis of the scalp.

  • Condition:
    • Scalp Psoriasis
  • Intervention:
    • Drug: Tildrakizumab
    • Drug: 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

Inclusion Criteria:

  • Participants should be 18 years or older at the time of signing the informed consent during the Screening visit.
  • Participants with a clinical diagnosis of chronic plaque psoriasis of at least 6 months, as confirmed by Investigator.
  • Participants must have moderate to severe plaque psoriasis of the scalp at Screening and at Baseline, defined by:
    • Scalp Investigator Global Assessment of ≥ 3
    • Psoriasis Scalp Severity Index score of ≥ 12
    • ≥ 30% of scalp surface area affected
  • Participant must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:
    • Physician Global Assessment for Skin of at least moderate severity (score of ≥ 3 on a 5-pointer scale)
    • Psoriasis Area and Severity Index score of ≥ 12
    • Body Surface Area involvement of ≥ 10%
  • Participants must be considered candidates for systemic therapy, meaning scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
  • Participants must not be intending to conceive for the duration of the study and for 6 months after the last dose of study medication.
  • Participants must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.

Exclusion Criteria:

  • Participants 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.
  • Participants with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis. (Prior use of TNF-alpha inhibitors with a wash-out period of 12 weeks would be allowed. However, the number of participants with prior use of TNF-alpha inhibitors would be capped at 40% and the analysis will be stratified based on prior use of these biologics.) 
  • Participants with a positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result.
  • Participants with a prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma of skin with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
  • Participants who have any concomitant medical condition which in the opinion of the Investigator could affect the study outcome or present an unacceptable risk.
  • Participants who were hospitalized due to an acute cardiovascular event (such as myocardial infarction, cerebrovascular accident, cardiovascular illness [e.g. angina pectoris], or cardiovascular surgery [such as coronary artery bypass grafting]) within 6 months before Screening.
  • Participants who have a history of alcohol or drug abuse in the previous year.

Investigational Plan:

The duration of the study will be about 76 weeks (19 months) and will include a screening period (up to 4 weeks), a 52-week treatment period (16 weeks are double-blind, placebo-controlled followed by 36 weeks of double-blind, active treatment) and finally a 20-week observational safety follow-up period.

Participants are initially randomized to receive tildrakizumab or placebo via subcutaneous (SC) injection. At Week 16, those individuals who previously received placebo will then receive active study drug (tildrakizumab).

Principal Investigator:

A/Prof Peter Foley



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hidradenitis suppurativa research study - 1

Title

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects with Moderate to Severe Hidradenitis Suppurativa.

Background and Rationale

Hidradenitis suppurativa is an inflammatory, debilitating skin disease with a characteristic clinical presentation of recurrent or chronic painful or suppurating lesions that most commonly present in the axilla, inguinal, and anogenital regions. Risankizumab is a humanized mAb of the IgG1 subclass directed towards IL 23p19. The antibody (Ab) has been engineered to reduce Fcγ receptor and complement binding and potential charge heterogeneity. Risankizumab binds with high affinity to human IL-23 and may address the current needs for patients with HS.

Purpose

This study is to evaluate the safety and efficacy of 2 dose levels of risankizumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

  • Condition:
    • Hidradenitis Suppurativa
  • Intervention:
    • Drug: Risankizumab
    • Drug: Placebo for risankizumab
  • 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 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Participant with moderate to severe Hidradenitis Suppurativa (HS) for at least one year prior to Baseline visit.
  • HS lesions present in at least two distinct anatomical areas.
  • Draining fistula count of <=20 at Baseline visit.
  • Total abscesses and nodule count (AN count) of >= 5 at Baseline visit.
  • Participants are required to use a daily antiseptic wash on their HS lesions.
  • Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.

Exclusion Criteria:

  • Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
  • Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
  • Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
  • Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit. 
  • Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
  • Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.

Investigational Plan:

The duration of the study will be up to 85 weeks and will include an approximately 35-day screening period followed by 2 treatment periods.

In Period A, participants are randomized to receive either investigational medication (active study drug) or placebo via injection. In Period B, all participants will receive investigational treatment.


Principal Investigator:

A/Prof Peter Foley


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hidradenitis suppurativa reSearch study - 2

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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Hidradenitis Suppurativa Research Study - 3

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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