A Study to Test the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

  • STATUS
    Recruiting
  • End date
    May 14, 2023
  • participants needed
    490
  • sponsor
    UCB Biopharma SRL
Updated on 14 May 2021
antibiotics
abscess
hidradenitis
bimekizumab

Summary

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

Details
Condition Hidradenitis Suppurativa, Acne Inversa
Treatment Placebo, Bimekizumab
Clinical Study IdentifierNCT04242498
SponsorUCB Biopharma SRL
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

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
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 (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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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