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The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - certolizumab pegol | Experimental | Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Active Treatment period and through the subsequent Open-Label Extension Period. |
|
| Cohort A - placebo | Placebo Comparator | Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period. |
|
| Cohort B - certolizumab pegol - Open-label | Experimental | Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab pegol | Drug | Certolizumab Pegol
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of Certolizumab pegol (CZP) at Week 16 | Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16. | Week 16 |
| Plasma anti-CZP antibody titers at Week 16 | Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16. | Week 16 |
| Plasma concentrations of CZP at Week 52 | Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52. | Week 52 |
| Plasma anti-CZP antibody titers at Week 52 | Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious treatment emergent adverse events | A serious treatment emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:
|
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Inclusion Criteria:
Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
>Clinically relevant facial or scalp involvement
>Clinically relevant genital involvement
>Clinically relevant palm and sole involvement
>Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with >50 % to <80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0007 50175 | Phoenix | Arizona | 85006 | United States | ||
| Ps0007 50162 |
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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|
| Placebo | Drug | Placebo
|
|
| From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years) |
| Incidence of treatment emergent adverse events leading to withdrawal | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. | From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years) |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Ps0007 50161 | Los Angeles | California | 90045 | United States |
| Ps0007 50196 | Thousand Oaks | California | 91320 | United States |
| Ps0007 50217 | Boca Raton | Florida | 33428 | United States |
| Ps0007 50248 | Hialeah | Florida | 33016 | United States |
| Ps0007 50169 | Jacksonville | Florida | 32256 | United States |
| Ps0007 50268 | Miami | Florida | 33155 | United States |
| Ps0007 50269 | Wellington | Florida | 33449 | United States |
| Ps0007 50230 | Rome | Georgia | 30161 | United States |
| Ps0007 50168 | Chicago | Illinois | 60611 | United States |
| Ps0007 50286 | Topeka | Kansas | 66614 | United States |
| Ps0007 50232 | Detroit | Michigan | 48202 | United States |
| Ps0007 50156 | Arlington | Texas | 76011 | United States |
| Ps0007 50277 | San Antonio | Texas | 78218 | United States |
| Ps0007 50183 | Calgary | Canada |
| Ps0007 50225 | Calgary | Canada |
| Ps0007 50187 | Edmonton | Canada |
| Ps0007 50265 | San Juan | Puerto Rico |
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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