An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)
A legfontosabb adatok
- Hol
- Charleston, Chicago, Columbus, Dallas, Fargo, Hollywood, Macon, Miami, Murray, Norfolk, North Little Rock, San Antonio, Sandy Springs, Seattle, Stanford, Washington D.C. és Waterford (Egyesült Államok)Mind a 17 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Charleston, South CarolinaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Columbus, IndianaHospital not named in the registryNo longer taking part
- Dallas, TexasHospital not named in the registryNo longer taking part
- Fargo, North DakotaHospital not named in the registryNo longer taking part
- Hollywood, FloridaHospital not named in the registryNo longer taking part
- Macon, GeorgiaHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Murray, KentuckyHospital not named in the registryNo longer taking part
- Norfolk, VirginiaHospital not named in the registryNo longer taking part
- North Little Rock, ArkansasHospital not named in the registryNo longer taking part
- San Antonio, TexasHospital not named in the registryNo longer taking part
- Sandy Springs, GeorgiaHospital not named in the registryNo longer taking part
- Seattle, WashingtonHospital not named in the registryNo longer taking part
- Stanford, CaliforniaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
- Waterford, ConnecticutHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- MoonLake Immunotherapeutics AG
- Azonosító
- NCT06768671
- A regiszteradat frissítve
- 2026. november 9.
- Eredeti leírás
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.A teljes eredeti leírásKevesebb
An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years at the Time of Study Inclusion With Active Moderate to Severe Hidradenitis Suppurativa
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Bevonási feltételek: Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent; Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent; Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III); Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS ; Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study; Participants with a body weight of ≥ 40 kg.
Kizáró feltételek: Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk; Participants with a known hypersensitivity to sonelokimab or any of its excipients; Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS; Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk; Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS; Participants with a confirmed or suspected diagnosis of inflammatory bowel disease; Participants with a draining fistula count of ≥20 at the Screening Visit.