BE HEARD

Australia, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Spain, Switzerland, Turkey, United States (ICTRP)

ID di studio ICTRP
NCT04242446 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
non disponibile

Titolo accademico
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 (ICTRP)

Titolo pubblico
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (ICTRP)

Malattie studiate
Hidradenitis Suppurativa (ICTRP)

Intervento studiato
Drug: Bimekizumab;Other: Placebo (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years

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
(ICTRP)

non disponibile

Endpoint primari e secondari
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 (ICTRP)

Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16;Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16;Absolute change from Baseline in Skin Pain score at Week 16;Percentage of participants achieving Skin Pain response at Week 16;Percentage of participants with treatment-emergent adverse events (TEAEs) during the study;Percentage of participants with serious treatment-emergent adverse events during the study;Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
UCB Cares, 001 844 599 2273 (ICTRP)

ID secondari
2019-002550-23, HS0003 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04242446 (ICTRP)