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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1293-2383 | Other Identifier | WHO universal trial number (UTN) | |
| 2023-503859-10-00 | Registry Identifier | CTIS (EU CT) |
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The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque psoriasis (PSO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimekizumab | Experimental | Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks). |
|
| ustekinumab | Active Comparator | Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimekizumab | Drug | Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area Severity Index 90 (PASI90) response at Week 16 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 16 |
| Investigator´s Global Assessment (IGA) 0/1 response at Week 16 | The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI75 response at Week 4 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
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Inclusion Criteria:
Study participant must be 6 to <18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation
Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit
Study participant meets the following at both the Screening and Baseline Visits:
PASI score ≥10 plus at least 1 of the following:
i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | 1-844-599-2273 (USA) | ucbcares@ucb.com | |
| UCB Cares | Contact | 001 844 599 2273 | UCBCares@ucb.com |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0021 50162 | Active, not recruiting | Fountain Valley | California | 92708 | United States | |
Data from this study 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 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. This plan may change if a determination is made that the data cannot be adequately anonymized.
Data from this study 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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| ustekinumab | Drug | Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study. |
|
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| placebo | Drug | Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding. |
|
| Week 4 |
| PASI100 response at Week 16 | A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 16 |
| PASI90 response at Week 48 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 48 |
| IGA 0/1 response at Week 48 | The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline. | Week 48 |
| PASI100 response at Week 48 | A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 48 |
| IGA 0 response at Week 16 | The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline. | Week 16 |
| IGA 0 response at Week 48 | The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline. | Week 48 |
| Incidence of treatment-emergent adverse events (TEAE)s | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. | From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) |
| Incidence of serious TEAEs | An serious adverse event (SAE) must meet 1 or more of the following criteria:
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. | From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) |
| Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. | From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) |
| Incidence of TEAEs leading to withdrawal from the study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent withdrawal from study. | From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) |
| Incidence of TEAEs predefined as safety topics of interest | Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions. | From Baseline (Week 0) to Week 48 and to End of Safety Follow-up (up to Week 164) |
| Change from Baseline in vital signs (systolic blood pressure) | Blood pressure will be measured in millimeters of mercury (mmHg). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in vital signs (diastolic blood pressure) | Blood pressure will be measured in millimeters of mercury (mmHg). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in vital signs (pulse rate) | Pulse rate will be measured in beats per minute (beats/min). | From Baseline (Week 0) up to Week 48 |
| Incidence of clinically significant physical examination findings reported as TEAEs | Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs. | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in height (growth assessment) | Growth assessment, as assessed by the change from Baseline in height. | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in weight (growth assessment) | Growth assessment, as assessed by the change from Baseline in weight. | From Baseline (Week 0) up to Week 48. |
| Change from Baseline in hematology parameters (platelet count) | Platelets will be measured in number of platelets per liter (10^9/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in hematology parameters (erythrocytes) | Erythrocytes will be measured in number of red blood cells per liter (10^12/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in hematology parameters (hemoglobin) | Hemoglobin will be measured in grams per liter (g/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in hematology parameters (hematocrit) | Hematocrit will be measured in volume percentage (%) of red blood cells in blood. | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) | Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes) | Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be measured in number of white blood cells per liter (10^9/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) | Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) | Clinical chemistry parameters will be measured in micromols per liter (μmol/L). | From Baseline (Week 0) up to Week 48 |
| Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16 | The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). | Week 16, compared to Baseline |
| Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48 | The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). | Week 48, compared to Baseline |
| Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline | The CHAQ is a questionnaire designed to capture physical function in children and adolescents with juvenile rheumatoid arthritis. The CHAQ comprises 2 indices, Disability and Discomfort. The Disability Index assesses the degree of difficulty experienced over the past week across 30 items in the following 8 categories of the daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The Disability Index ranges from 0 (no disability) to 3 (maximum disability). Discomfort is determined by the presence of pain, as measured by a 100-mm visual analogue scale (VAS). In addition, a final global assessment item asks study participants to rate how they are doing by placing a mark on a 100 mm VAS. | Week 16, compared to Baseline |
| Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16 | The Peak Pruritus NRS measures the worst level of itching in the past 24 hours on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). | Week 16, compared to Baseline |
| Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period | Plasma bimekizumab concentrations prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration | From Baseline to End of OLE Period (up to 144 weeks) |
| Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period | Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration | From Baseline to End of OLE Period (up to 144 weeks) |
| Ps0021 50161 |
| Active, not recruiting |
| Los Angeles |
| California |
| 90045 |
| United States |
| Ps0021 50196 | Completed | Northridge | California | 91325 | United States |
| Ps0021 50581 | Withdrawn | Miami | Florida | 33165 | United States |
| Ps0021 50344 | Active, not recruiting | Indianapolis | Indiana | 46250 | United States |
| Ps0021 50599 | Withdrawn | Kew Gardens | New York | 11415 | United States |
| Ps0021 50084 | Active, not recruiting | Charleston | South Carolina | 29425 | United States |
| Ps0021 50201 | Completed | Arlington | Texas | 76011 | United States |
| Ps0021 50355 | Active, not recruiting | Dallas | Texas | 75235 | United States |
| Ps0021 40121 | Active, not recruiting | Brussels | Belgium |
| Ps0021 40420 | Withdrawn | Liège | Belgium |
| Ps0021 50618 | Active, not recruiting | Mississauga | Canada |
| Ps0021 50357 | Active, not recruiting | St. John's | Canada |
| Ps0021 50617 | Withdrawn | St. John's | Canada |
| Ps0021 40748 | Active, not recruiting | Plzen-bory | Czechia |
| Ps0021 40742 | Withdrawn | Argenteuil | France |
| Ps0021 40754 | Withdrawn | Nantes | France |
| Ps0021 40740 | Active, not recruiting | Bad Bentheim | Germany |
| Ps0021 40515 | Completed | Berlin | Germany |
| Ps0021 40138 | Active, not recruiting | Bonn | Germany |
| Ps0021 40356 | Active, not recruiting | Dresden | Germany |
| Ps0021 40023 | Completed | Erlangen | Germany |
| Ps0021 40645 | Active, not recruiting | Frankfurt am Main | Germany |
| Ps0021 40758 | Active, not recruiting | Hamburg | Germany |
| Ps0021 40249 | Active, not recruiting | Kiel | Germany |
| Ps0021 40747 | Completed | Mainz | Germany |
| Ps0021 40177 | Active, not recruiting | Münster | Germany |
| Ps0021 40746 | Active, not recruiting | Debrecen | Hungary |
| Ps0021 40744 | Active, not recruiting | Kaposvár | Hungary |
| Ps0021 40745 | Active, not recruiting | Szeged | Hungary |
| Ps0021 40440 | Active, not recruiting | Ancona, Località Torrette | Italy |
| Ps0021 40749 | Active, not recruiting | Catania | Italy |
| Ps0021 40085 | Active, not recruiting | Pisa | Italy |
| Ps0021 40567 | Active, not recruiting | Roma | Italy |
| Ps0021 20071 | Recruiting | Nagasaki | Japan |
| Ps0021 20033 | Recruiting | Nagoya | Japan |
| Ps0021 20337 | Recruiting | Shimotsuga-gun | Japan |
| Ps0021 40741 | Active, not recruiting | Bialystok | Poland |
| Ps0021 40832 | Active, not recruiting | Lodz | Poland |
| Ps0021 40091 | Active, not recruiting | Nowa Sól | Poland |
| Ps0021 40737 | Active, not recruiting | Rzeszów | Poland |
| Ps0021 40743 | Active, not recruiting | Szczecin | Poland |
| Ps0021 40625 | Active, not recruiting | Warsaw | Poland |
| Ps0021 40334 | Active, not recruiting | Wroclaw | Poland |
| Ps0021 40738 | Active, not recruiting | Wroclaw | Poland |
| Ps0021 40750 | Active, not recruiting | Alicante | Spain |
| Ps0021 40159 | Withdrawn | Barcelona | Spain |
| Ps0021 40751 | Active, not recruiting | Esplugues de Llobregat | Spain |
| Ps0021 40752 | Completed | Granada | Spain |
| Ps0021 40753 | Withdrawn | Santiago de Compostela | Spain |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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