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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.


Atopic Dermatitis Research Study

Adult Eczema Research Study - 65 Weeks

Scalp Psoriasis Research Study

Hidradenitis Suppurativa Research Study - 1

Hidradenitis Suppurativa Research Study - 2

Alopecia Areata - Brave AA2


research study for atopic dermatitis - 28 weeks

Title

A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

Background and Rationale

Atopic dermatitis is a chronic type 2 inflammatory skin disease that is associated with heterogeneous and highly variable signs and symptoms. The symptoms of AD include cutaneous itch, pain, sleep disturbance, and mental health symptoms. Atopic dermatitis patients also can suffer from comorbid infectious, autoimmune, respiratory, neuropsychiatric, and musculoskeletal disorders. Atopic dermatitis might have a systemic involvement with global impact beyond the skin signs and symptoms. As a targeted agent, selectively inhibiting the IL-4 and IL-13 signaling, dupilumab is a novel systemic therapy for AD, demonstrating significant and clinically meaningful benefits combined with a favorable safety profile, compared to existing non-selective systemic immunosuppressants.

Purpose

To evaluate the effect of dupilumab on sleep quality in adult patients with moderate to severe atopic dermatitis (AD). To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study.

  • Condition:
    • Atopic Dermatitis
  • Intervention:
    • Biological: Dupilumab
    • Biological: Placebo
  • Phase: 4
  • 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

Participants, male or female, 18 years or older:

  • with diagnosed chronic atopic dermatitis (AD), demonstrated 1) inadequate response to topical medications, 2) expected severity of AD, and 3) sleep disturbance
  • having applied skin emollients (moisturizers) at least 7 days before screening
  • having applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening
  • willing and able to comply with all clinic visits and study-related procedures
  • providing signed informed consent

Exclusion Criteria

Participants excluded from the study:

  • with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that may present unreasonable risk to patients or interfere with study assessment, or any severe concomitant illness(es) that would adversely affect the patient's participation in the study, and contraindications of topical corticosteroids
  • at baseline, presence of any conditions listed as criteria for study drug discontinuation.

Investigational Plan

The duration of the study will be about 28 weeks (7 months) and will include a screening period (up to 4 weeks) and a 24 week treatment period (12 weeks are double-blind, placebo-controlled followed by a 12 week open-label extension period).

Participants are initially randomized to receive dupilumab or placebo via subcutaneous (SC) injection. During the open-label period, those individuals who previously received placebo will then receive active study drug (dupilumab).

Principal Investigator:
A/Prof Peter Foley


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adult eczema research study (65 weeks)

Title

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects with Moderate to Severe Atopic Dermatitis.

Purpose

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects.

  • Condition:
    • Atopic Dermatitis
  • Intervention:
    • Biological: Risankizumab
    • Biological: Placebo for Risankizumab
  • 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 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:

  • Adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
  • A diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
  • Moderate to severe AD at the Baseline Visit
  • History of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

  • Prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
  • Concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

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 reearch 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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alopecia areata research study - brave aa2

Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata.


Background and Rationale

Alopecia areata (AA) is an autoimmune disease usually characterized by patches of non-scarring hair loss that can involve the scalp, face, and body affecting children and adults across all ages, races, and sexes. Baricitinib is an orally available, selective Janus kinase (JAK) inhibitor with potency and selectivity for JAK1 and JAK2. The primary objective of this study is to test the hypothesis that the dose of baricitinib (low dose and/or high dose) is superior to placebo in the treatment of patients with severe or very severe AA.


Purpose

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

  • Condition:
    • Alopecia Areata
  • Intervention:
    • Drug: Baricitinib
    • 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 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Are at least 18 years and ≤ 60 years for males (≤ 70 years of age for females) at the time of informed consent
  • Have severe or very severe AA, as determined by all of the following:
    • current AA episode of more than 6 months' duration and hair loss encompassing ≥ 50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline
    • no spontaneous improvement over the past 6 months
    • current episode of severe or very severe AA of less than 8 years             

Note: participants who have severe or very severe AA for ≥ 8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years

  • Male or nonpregnant, nonbreastfeeding female participants

Exclusion Criteria:

  • Primarily "diffuse" type of AA
  • Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA
  • Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment)

Investigational Plan:

The study is divided into 4 periods: a 5-week screening period, a 36-week double-blind, placebo-controlled treatment period, a 68-week long-term extension period (that includes a randomized down-titration of baricitinib), and a post-treatment 4-week follow-up period. The baricitinib doses will be selected in Study JAHO by the Decision Point Committee. It is expected that a maximum of up to 2 doses (high dose, low dose) will be tested against placebo in this study.

Following screening, subjects who meet all criteria for enrollment will be randomized in a 2:2:3 ratio to receive placebo QD, baricitinib low dose QD, or baricitinib high dose QD at Visit 2. If only 1 dose of baricitinib is included in this study, subjects will be randomized in a 1:1 ratio to receive placebo or baricitinib QD.

All subjects who have completed the double-blind treatment period (Week 36) will enter the long-term extension period (up to 68 weeks of additional treatment). Subjects will continue on their current treatment assignment, unless pre-defined criteria are met for rescue. At Week 52, treatment assignment may change depending on whether subjects are considered responders or non-responders.

Principal Investigator:

A/Prof Peter Foley


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