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Tests treatment safety and results for Hidradenitis Suppurativa
Official title A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT06921850
What this study is testing
What is Bimekizumab?
Bimekizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hidradenitis suppurativa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 17
You may be able to join if
- Study participant must be 12 to \<18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants...
- Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit.
- Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules)...
- Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed...
- Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS
You likely can't join if
- Study participant has a draining tunnel count of \>20 at either the Screening or Baseline Visits.
- Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab...
- Study participant has previously participated in this study or has received previous therapy with bimekizumab.
- Study participant has a history of IBD or symptoms suggestive of IBD.
- History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections...
See the full eligibility criteria
- Study participant must be 12 to \<18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to \<18 years of age at...
- Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit.
- Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the Screening and Baseline Visits.
- Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed at both the Screening and Baseline Visits.
- Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS
- Study participant must weigh ≥30kg at the Screening Visit.
- Study participant has a draining tunnel count of \>20 at either the Screening or Baseline Visits.
- Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR primary failure to more than 1 biologic...
- Study participant has previously participated in this study or has received previous therapy with bimekizumab.
- Study participant has a history of IBD or symptoms suggestive of IBD.
- History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
- Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
- Study participant has the presence of active suicidal ideation, or positive suicide behavior,
- Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit.
- Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Roseville, California, United States
- Sacramento, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Bowling Green, Kentucky, United States
- Clarkston, Michigan, United States
- Fort Gratiot, Michigan, United States
- Troy, Michigan, United States
- Chapel Hill, North Carolina, United States
- Fairborn, Ohio, United States
- Arlington, Texas, United States
- Berlin, Germany
- Mainz, Germany
- Lodz, Poland
- Warsaw, Poland
- Wroclaw, Poland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Roseville, California, United States; Sacramento, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Bowling Green, Kentucky, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.