Trial · NCT06668181
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
NCT06668181, Phase 3, Recruiting, UCB Biopharma SRL
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis. Trials, record NCT06668181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06668181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
- NCT number
- NCT06668181
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
- Interventions
- Bimekizumab
- First posted
- 2024-10-31
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma bimekizumab concentrations over the Initial Treatment Period | Up to Week 16 | Plasma samples will be collected at pre-specified timepoints for measurement of plasma bimekizumab concentrations over the Initial Treatment Period. |
| Secondary | Incidence of Treatment-emergent adverse events (TEAEs) | From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks) | 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 the IMP. |
| Secondary | Incidence of Serious TEAEs | From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks) | A 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 |
| Secondary | Incidence of TEAEs leading to discontinuation of investigational medicinal product (IMP) | From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks) | 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 the IMP. |
| Secondary | Incidence of TEAEs leading to withdrawal from the study | From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks) | 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 the IMP. |
| Secondary | Incidence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions) | From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks) | Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions. |
| Secondary | Change from Baseline in vital signs (systolic and diastolic blood pressure) at Week 16 | Baseline and Week 16 | Blood pressure will be measured in millimeters of mercury (mmHg). |
| Secondary | Change from Baseline in vital signs (heart rate) at Week 16 | Baseline and Week 16 | Heart rate will be measured in beats per minute (beats/min). |
| Secondary | Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Week 16 | Baseline and Week 16 | Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L). |
| Secondary | Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) at Week 16 | Baseline and Week 16 | Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06668181
GET https://conductscience.org/api/trials/v1/NCT06668181/registered?page=2