The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
658
Subjects will receive bimekizumab at pre-specified time-points.
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical events
Time frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.
Time frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
HiSCR50 is defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Results will be presented individually per week listed under time points.
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Hs0005 50140
Birmingham, Alabama, United States
Hs0005 50175
Phoenix, Arizona, United States
Hs0005 50162
Fountain Valley, California, United States
Hs0005 50161
Los Angeles, California, United States
Hs0005 50220
San Diego, California, United States
Hs0005 50196
Thousand Oaks, California, United States
Hs0005 50199
Miami, Florida, United States
Hs0005 50205
North Miami Beach, Florida, United States
Hs0005 50152
Orange Park, Florida, United States
Hs0005 50184
Pembroke Pines, Florida, United States
...and 135 more locations
Time frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
HiSCR75 is defined as at least a 75 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Results will be presented individually per week listed under time points.
Time frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Percentage of participants with Flare
Flare is defined as a ≥25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to Baseline. Results will be presented individually per week listed under time points.
Time frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level. Results will be presented individually per week listed under time points.
Time frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL. Results will be presented individually per week listed under time points.
Time frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180