A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab
A legfontosabb adatok
- Ki végzi
- Boehringer Ingelheim
- Hol
- Fountain Valley, Los Angeles, Sacramento és Thousand Oaks (Egyesült Államok)Mind a 4 helyszín megnézéseMég 21 másik országban, 88 helyszínen
- Azonosító
- NCT06241573
- EU 2023-508377-82-00
- U1111-1300-2310
- Állapot
- Leállítva
- Fázis
- 2/3. fázis
- Résztvevők
- 39 fő vett részt
- Kezdés
- 2024. máj. 8.
- Befejezés
- 2025. ápr. 11.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoport
- A vizsgált kezelések
- Spesolimab
- Placebo
- A regiszteradat frissítve
- 2026. június 17.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 9 feltétel megnézéseKevesebb
Ki vehet részt
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration
- Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial
- Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Ki nem vehet részt
- Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials
- Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials
- Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial
- Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection; Further exclusion criteria apply
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Helyszínek itt: Egyesült Államok
Még 21 másik országban, 88 helyszínen
- First OC DermatologyFountain Valley, Egyesült ÁllamokNo longer taking part
- Dermatology Research AssociatesLos Angeles, Egyesült ÁllamokNo longer taking part
- Integrative Skin Science and Research-Sacramento-69402Sacramento, Egyesült ÁllamokNo longer taking part
- Clinical Trials Research InstituteThousand Oaks, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100).
A teljes eredeti leírásKevesebb
The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks.
Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.
A vizsgálat 3 csoportja
- Spesolimab low doseA vizsgált kezelés
Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Kezelés: Spesolimab és Placebo
- Spesolimab high doseA vizsgált kezelés
Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Kezelés: Spesolimab
- Spesolimab high dose with prior placeboA vizsgált kezelés
Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Kezelés: Spesolimab
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)
- A regiszteradat frissítve
- 2026. június 17.