Clinical Trials - For Clinicians

• 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

• 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 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