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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT04242446

Run by

UCB Biopharma SRL

People needed

505

Starts

2020-02-19

Expected to finish

2023-02-19

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Hs0003 50175 — Phoenix, Arizona, United States
• Hs0003 50161 — Los Angeles, California, United States
• Hs0003 50220 — San Diego, California, United States
• Hs0003 50205 — North Miami Beach, Florida, United States
• Hs0003 50153 — Ormond Beach, Florida, United States
• Hs0003 50141 — Tampa, Florida, United States
• Hs0003 50210 — Atlanta, Georgia, United States
• Hs0003 50280 — Watkinsville, Georgia, United States
• Hs0003 50425 — Murray, Kentucky, United States
• Hs0003 50198 — Beverly, Massachusetts, United States
• Hs0003 50146 — Boston, Massachusetts, United States
• Hs0003 50194 — Omaha, Nebraska, United States
• Hs0003 50208 — Las Vegas, Nevada, United States
• Hs0003 50137 — East Windsor, New Jersey, United States
• Hs0003 50235 — New York, New York, United States
• Hs0003 50151 — Chapel Hill, North Carolina, United States
• Hs0003 50177 — Cincinnati, Ohio, United States
• Hs0003 50138 — Columbus, Ohio, United States
• Hs0003 50204 — Tulsa, Oklahoma, United States
• Hs0003 50147 — Hershey, Pennsylvania, United States
• Hs0003 50008 — Johnston, Rhode Island, United States
• Hs0003 50180 — Providence, Rhode Island, United States
• Hs0003 50142 — Nashville, Tennessee, United States
• Hs0003 50201 — Arlington, Texas, United States
• Hs0003 50140 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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