A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
A legfontosabb adatok
- Fázis
- 3. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
13 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálat adatai
- Ki végzi
- MoonLake Immunotherapeutics AG
- Azonosító
- EU 2025-520564-17-00
- A regiszteradat frissítve
- 2026. november 5.
- Eredeti leírás
To evaluate the long-term safety and tolerability of sonelokimab in participants with moderate to severe HSA teljes eredeti leírásKevesebb
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
To evaluate the long-term safety and tolerability of sonelokimab in participants with moderate to severe HS
Bevonási feltételek: Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the EOT visit (Week 52 [M1095-HS-301/302] or Week 24 [M1095-HS-304]); Participants must have received their last dose of study treatment in the parental study no more than 8 weeks before the first dose in this OLE study; Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if women of childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of study treatment in this study (Week 0). Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment (See Protocol Appendix 1 for the definitions of nonchildbearing potential, childbearing potential, and highly effective methods of contraception); Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment; Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator; Participants are able to understand and provide signed informed consent, or assent with parental/legal guardian consent, as applicable, per local regulations and guidelines.
Kizáró feltételek: Participants who plan to participate in another interventional study for a drug or device during this study; Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study, as below:; Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in this protocol (Section 6.9.2).