A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I)

UCB

Status and phase: Completed; Phase 3

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04242446

2019-002550-23 (EudraCT Number)

HS0003

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Enrollment: 505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (eg, 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 (ie, 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:

  1. Not a woman of childbearing potential (WOCBP) OR
  2. 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 (eg, 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 as stated in this protocol
• Concomitant and prior medication restrictions
• Myocardial infarction or stroke within the 6 months prior to the Screening Visit
• Study participant has the presence of active suicidal ideation, or positive suicide behavior using the "Screening" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
• Presence of moderately severe major depression or severe major depression
• Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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505 participants in 4 patient groups, including a placebo group

Bimekizumab dosing regimen 1

Experimental group

Description:

Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.

Treatment:

Drug: Bimekizumab

Bimekizumab dosing regimen 2

Experimental group

Description:

Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.

Treatment:

Drug: Bimekizumab

Bimekizumab dosing regimen 3

Experimental group

Description:

Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.

Treatment:

Drug: Bimekizumab

Placebo Group

Placebo Comparator group

Description:

Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.

Treatment:

Other: Placebo

Drug: Bimekizumab