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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505323-31 | Registry Identifier | EU Clinical Trials | |
| U1111-1316-5308 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab | Experimental | Study participants will receive a bimekizumab dose which is weight-dependent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Bimekizumab will be administered at pre-specified timepoints. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Plasma bimekizumab concentrations at Week 16 | Plasma samples will be collected prior to dosing for measurement of plasma concentrations of bimekizumab at the specified timepoint. | At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period | The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. 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 IMP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | +18445992273 | ucbcares@ucb.com | |
| UCB Cares | Contact | 001 844 599 2273 |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hs0006 50175 | Recruiting | Phoenix | Arizona | 85006 | United States | |
| Hs0006 50708 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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| From Baseline until end of the Initial Treatment Period (up to 16 weeks) |
| Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period | The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. A SAE is defined as any untoward medical occurrence that, at any dose:
| From Baseline until end of the Initial Treatment Period (up to 16 weeks) |
| Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period | The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to IMP. | From Baseline until end of the Initial Treatment Period (up to 16 weeks) |
| Exposure-adjusted incidence rate of Selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period | Safety topics of interest for this study include events for which special monitoring will be for infections (serious, opportunistic, fungal, and tuberculosis [TB]), inflammatory bowel disease (IBD), and injection site reactions. | Up to Week 16 |
| Mean Change from Baseline in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) at Week 16 | Blood pressure (Systolic Blood Pressure and Diastolic Blood Pressure) will be measured in millimeters of mercury (mmHg). | Baseline and Week 16 |
| Mean Change from Baseline in vital sign (Pulse rate) at Week 16 | Pulse Rate will be measured in beats per minute (beats/min). | Baseline and Week 16 |
| Mean Change from Baseline in Biochemistry Laboratory Analyses (glucose, potassium, sodium, calcium) at Weeks 4,12, and 16 | Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L). | Baseline, Weeks 4, 12, and 16 |
| Mean Change from Baseline in Biochemistry Laboratory Analyses (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Weeks 4,12, and 16 | Biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen [BUN], and creatinine) will be measured in micromols per liter (μmol/L). | Baseline, Weeks 4, 12, and 16 |
| Mean Change from Baseline in Biochemistry Laboratory Analyses (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Weeks 4,12, and 16 | Biochemistry parameters (alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) will be measured in units per liter (U/L). | Baseline, Weeks 4, 12, and 16 |
| Mean Change from Baseline in Hematology Laboratory Analyses (hemoglobin) at Weeks 4,12, and 16 | Hemoglobin will be measured in grams per liter (g/L). | Baseline, Weeks 4, 12, and 16 |
| Mean Change from Baseline in Hematology Laboratory Analyses (hematocrit) at Weeks 4,12, and 16 | Hematocrit will be measured in volume percentage (%) of red blood cells in blood. | Baseline, Weeks 4, 12, and 16 |
| Mean Change from Baseline in Hematology Laboratory Analyses (platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Weeks 4, 12, and 16 | Platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes will be measured in number of blood cells per liter (10^9/L) | Baseline, Weeks 4, 12, and 16 |
| Mean Change from Baseline in Hematology Laboratory Analyses (erythrocytes) | Erythrocytes will be measured in number of red blood cells per liter (10^12/L). | Baseline, Week 4, 12, and 16 |
| Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies at Baseline and Week 16 | Positive, negative, and missing plasma anti-bimekizumab antibodies detection prior to and following IMP administration during the Initial Treatment Period. | Baseline and Week 16 |
| Recruiting |
| Roseville |
| California |
| 95661 |
| United States |
| Hs0006 50684 | Active, not recruiting | Sacramento | California | 95815 | United States |
| Hs0006 50707 | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Hs0006 50199 | Recruiting | Miami | Florida | 33136 | United States |
| Hs0006 50712 | Recruiting | Bowling Green | Kentucky | 42104 | United States |
| Hs0006 50178 | Recruiting | Clarkston | Michigan | 48346 | United States |
| Hs0006 50710 | Recruiting | Fort Gratiot | Michigan | 48059 | United States |
| Hs0006 50711 | Recruiting | Troy | Michigan | 48084 | United States |
| Hs0006 50706 | Recruiting | Chapel Hill | North Carolina | 27516 | United States |
| Hs0006 50202 | Recruiting | Fairborn | Ohio | 45324 | United States |
| Hs0006 50201 | Recruiting | Arlington | Texas | 76011 | United States |
| Hs0006 40326 | Recruiting | Berlin | Germany |
| Hs0006 40747 | Recruiting | Mainz | Germany |
| Hs0006 40625 | Recruiting | Warsaw | Poland |
| Hs0006 40761 | Recruiting | Warsaw | Poland |
| Hs0006 40095 | Recruiting | Wroclaw | Poland |
| Hs0006 40845 | Recruiting | Wroclaw | Poland |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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