Clinical Trials - For Clinicians

• 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

• 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

• 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

• 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

• 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

• 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