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Skin Health Institute

Clinical Trials - For Clinicians

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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 IIIb Psoriasis

Phase IV Psoriasis

Phase III Hidradenitis Suppurativa Research Study

Phase IIIb Psoriasis

Title

A Phase 3b, multicenter, interventional, open-label study of adult subjects with moderate to severe plaque psoriasis who have a suboptimal response to secukinumab or ixekizumab and are switched to risankizumab.

Background and Rationale

Psoriasis is a chronic debilitating immune-mediated disease characterized by marked inflammation of the skin that results in thick, erythematous, scaly plaques involving the skin. While the majority of mild psoriasis patients are managed with topical therapies, those with moderate or severe and/or refractory disease usually require phototherapy and/or systemic therapy. 

Risankizumab is a humanized monoclonal antibody (mAb) of the immunoglobin (Ig) G1 subclass directed towards the p19 subunit of IL-23. Risankizumab binds with high affinity to human IL-23. Secukinumab and ixekizumab are anti-IL-17A antibodies. Important evidence is lacking on the efficacy and safety of patients with suboptimal response on secukinumab or ixekizumab switching to risankizumab and the impact this switch has on patient's quality of life and treatment satisfaction. 

Purpose

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. 

  • Condition:
    • Plaque Psoriasis
  • Interventional Drug:
    • Risankizumab
  • Phase: 3b
  • Study Type: Interventional (Clinical Trial) 
  • Study Design:
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
    • 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

  • Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0)
  • Participant must be on labeled secukinumab or ixekizumab treatment (for at least 6 months) and are experiencing a sub-optimal response, at the time of Screening and Baseline visits
  • Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
  • Participant must be eligible for continued biologic therapy as assessed by the investigator

Exclusion Criteria

  • History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis
  • Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis
  • History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
  • History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator
  • Participant with exposure to risankizumab or any IL-23 inhibitors

Investigational Plan

The study duration will be up to 64 weeks. The study comprises a 30-day Screening Period, a 52-week open-label study period, and a 20-week follow-up period (after Week 40). The 52-week open-label period consists of an initial phase (Weeks 0 - 16) and a maintenance phase (Weeks 16 - 52). The follow-up period consists of a follow-up phone call 20 weeks after the last injection of study drug (at Week 40).

Participants will receive 2 injections of risankizumab subcutaneously at Weeks 0 and 4, and then every 12 weeks (q12w) until the last dose at Week 40.


Principal Investigator

A/Prof Peter Foley


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Phase IV Psoriasis

Title

Efficacy and safety comparison of brodalumab versus guselkumab in adult subjects with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab; COBRA

Background and Rationale

Psoriasis is an inflammatory skin disease that occurs in approximately 2% of the population worldwide. Psoriasis can be found anywhere on the body and appears like dry, red raised patches of skin covered by white silvery scales called plaques. These lesions can make the skin itch, burn, flake or bleed, and are located predominantly on the scalp, extensor sides of elbows and knees, and the sacral region. 

Brodalumab is an anti-IL-17 receptor antibody that blocks the inflammatory effects of IL-17 in the skin. Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody to the p19 subunit of IL-23 (IL-23p19). The primary objective of this trial will be to directly compare IL-17RA antagonism with IL-23p19 inhibition, thereby providing new scientific information that could support decision making in the clinical setting.

Purpose

This trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

  • Condition:
    • Plaque Psoriasis; Psoriasis Vulgaris; Psoriasis
  • Intervention:
    • Biological: Brodalumab
    • Biological: Guselkumab
    • Other: Placebo
  • Phase: 4
  • 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 and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Inclusion Criteria

  • Participant has a diagnosis of plaque psoriasis for at least 6 months before the first administration of investigational medicinal product (IMP) as determined by the investigator.
  • Participant has inadequately controlled plaque psoriasis currently treated with ustekinumab, and fulfil ALL of the following criteria:
    • 1. Ustekinumab administered at least 3 times at or higher than the approved dose or frequency for at least 24 weeks.
    • 2. IGA ≥2 at screening and baseline.
    • 3. Absolute PASI >3 at screening and baseline.
    • 4. The last administration of ustekinumab was ≥12 weeks before randomization.
  • Participant has no active tuberculosis at screening (negative QuantiFERON® or purified protein derivative [PPD] test). Participants with adequately treated latent tuberculosis are eligible.

Exclusion Criteria

  • Participant was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that would interfere with evaluations of the effect of IMP on plaque psoriasis.
  • Participant has clinically important active infections or infestations, chronic, recurrent, or latent infections or infestations, or is immunocompromised (e.g. human immunodeficiency virus).
  • Participant has any systemic disease (e.g. renal failure, heart failure, hypertension, liver disease, diabetes, anaemia) considered by the investigator to be clinically significant and uncontrolled.
  • Participant has a known history of Crohn's disease.
  • Participant has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
  • Participant has a history of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
  • Participant has a known history of active tuberculosis.
  • Participant has a history of suicidal behaviour (i.e. 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or baseline.
  • Participant has any suicidal ideation of severity 4 or 5 ('some intent to act, no plan' or 'specific plan and intent') based on the C-SSRS questionnaire at screening or baseline.
  • Participant has a Patient Health Questionnaire-8 (PHQ-8) score of ≥10, corresponding to moderate to severe depression at screening or baseline.
  • Participant has previously received more than 1 tumour necrosis factor α (TNF α) inhibitor.
  • Participant has previously been treated with any anti-interleukin (IL)-17A, anti-IL 17 receptor subunit A, or anti-IL-23 besides ustekinumab.
  • Participant has known or suspected hypersensitivity to any component(s) of the IMPs.

Investigational Plan

The study will run over 32 weeks, with the primary endpoint assessed at Week 16. Participants will receive subcutaneous injections of either brodalumab + placebo, or guselkumab + placebo according to a specified treatment regimen. The last injections will be given at Week 26.


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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