SUBSCRIBE TO OUR CLINICAL TRIALS NEWSLETTER
To receive weekly updates on our currently recruiting trials, fill out the following form.
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 I Atopic Dermatitis
Phase II Atopic Dermatitis
Phase II Atopic Dermatitis/Plaque Psoriasis
Phase II Onychomycosis
Phase IIa Hidradenitis Suppurativa Research Study
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:
- Interventional Drug:
- 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
Back to top
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
Back to top
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.
- Condition:
- Intervention:
- Drug: ASLAN004
- Other: Matching Placebo
- Phase: 1
- 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
Inclusion Criteria
- Adult patients who are of or older than the legal age in participating countries, who are able to read and understand, and willing to sign the informed consent form.
- Willing and able to comply with clinic visits and study-related procedures.
- Have a clinical diagnosis of chronic atopic dermatitis (per Eichenfield revised criteria of Hanifin and Rajka) that has been present for at least 3 years before the screening visit.
- Have an IGA score of ≥3 at the screening and baseline visits.
- Have ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
- Have an EASI score ≥16 at the screening and baseline visits.
- Have a history of inadequate response to a stable (≥1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
- Have applied a stable dose of an additive, basic, bland topical emollient (moisturizer) twice daily for at least 7 days before Randomization.
Exclusion Criteria
- Have received previous treatment with therapeutic agents targeting ligand or receptors of IL-4 or IL-13, including but not limited to dupilumab, lebrikizumab, or tralokinumab.
- Have a known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection or positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), positive Hepatitis C antibody (HCV) at the screening visit.
- Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, etc.
- Have a history of malignancy within 5 years before Randomization with the following exceptions: patient with a history of cured in situ carcinoma of the cervix, and/or non-metastatic squamous or basal cell carcinoma of the skin are allowed.
- Pregnant or breastfeeding women.
- Patients (females and males) who are unwilling to use adequate birth control, if of reproductive potential and sexually active.
Investigational Plan
Participants who meet eligibility criteria will be randomized to receive either ASLAN004 or the matching placebo, administered subcutaneously. The study is divided into 3 periods: a screening period of up to 35 days, a treatment period of 57 days, and a follow-up period of 84 days. Overall study participation will last about 25 weeks.
Principal Investigator
A/Prof Peter Foley
Back to top
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:
- 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
Read less
Back to top
Phase II Atopic Dermatitis/Plaque Psoriasis Research Study
Title
A Phase 2A, randomised, double-blind, vehicle-controlled, parallel group study to assess the efficacy, safety, tolerability and pharmacokinetics of PF-07038124 ointment for 6 weeks in participation with mild to moderate atopic dermatitis or plaque psoriasis.
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. The most common variant of psoriasis, plaque psoriasis (psoriasis vulgaris), is a chronic inflammatory skin disease characterized by red, scaly, raised plaques. PF-07038124 is a topical phosphodiesterase 4 (PDE4) inhibitor that is being investigated for the treatment of atopic dermatitis (AD) and plaque psoriasis. Based on its cytokine inhibition profile, topical administration of PF-07038124 is anticipated to provide potential therapeutic benefit in the treatment of AD and psoriasis by targeting the T-helper-2 response cytokines and TNF-α.
Purpose
This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-7038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.
- Condition:
- Atopic Dermatitis
- Plaque Psoriasis
- Intervention:
- Drug: PF-7038124 ointment
- Other: Vehicle ointment (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 70 Years (Adult, Older Adult)
- Sexes Eligible for Study: All
- Accepts Healthy Volunteers: No
Inclusion Criteria
- Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
- Plaque Psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.
Exclusion Criteria
- Presence of skin comorbidities that would interfere with study assessment or response to treatment.
- Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Investigational Plan
The total duration of study participation will be approximately 17 weeks, including a screening period of up to 6 weeks. Participants will receive either PF-07038124 ointment or a vehicle ointment (placebo) for 6 weeks during the treatment period. Following this, a safety follow-up period of 4-5 weeks will occur from last dose of study drug to last study visit.
Principal Investigator
A/Prof Peter Foley
Back to top
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:
- 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
Back to top
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
Back to top
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:
- 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
Back to top