Hidradenitis Suppurativa: Lutikizumab in adult and adolescent patients with moderate to severe hidradenitis suppurativa
Zusammenfassung der Studie
Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease characterized by the formation of nodules, abscesses, and scars in skin areas such as under the breasts, under the arms, on the inner thighs, in the groin, and on the buttocks. This study compares Lutikizumab to placebo for the treatment of adult and adolescent participants with moderate to severe HS. Lutikizumab is an investigational drug developed for the treatment of HS. Approximately 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at about 275 sites worldwide. Participation in this study lasts 52 weeks, followed by a follow-up 70 days after stopping the investigational drug. During the first phase of the study, participants will be randomly assigned to either the Lutikizumab or placebo group (placebo is a medication that looks like Lutikizumab but contains no active ingredient). The probability of receiving either treatment is 50 %. During the second phase of the study, participants who were in the Lutikizumab group in the first phase will be randomly assigned to one of two Lutikizumab treatment groups. Participants who were in the placebo group in the first phase will start treatment with Lutikizumab and will later also be assigned to one of the two Lutikizumab treatment groups.
(BASEC)
Untersuchte Intervention
In the first phase of the study, participants receive a subcutaneous injection every week for 16 weeks, either with Lutikizumab or placebo. During the second phase of the study, participants will be reassigned randomly. Those who were in the Lutikizumab treatment group in the first phase will receive either weekly or biweekly Lutikizumab injections for 36 weeks. Participants who were assigned to the placebo group in the first phase will first receive weekly Lutikizumab injections for 16 weeks, then for 20 weeks either weekly or biweekly Lutikizumab injections.
Participants will be regularly examined in the clinic during the study. The effectiveness of the treatment will be assessed through medical evaluations, blood tests, monitoring of side effects, and completion of questionnaires and diaries.
(BASEC)
Untersuchte Krankheit(en)
Hidradenitis Suppurativa (HS)
(BASEC)
- Participants must be at least 16 years old at the time of screening and have had a clinical diagnosis of moderate to severe HS for at least 6 months at study entry - At study entry, total HS lesion count of ≥ 5 - HS lesions in at least 2 different anatomical areas - At study entry, at least 1 anatomical area with HS involvement in Hurley stage II - Inadequate response to oral antibiotics after a treatment duration of at least 12 weeks - Intolerance to antibiotics (BASEC)
Ausschlusskriterien
- Signs of infection with hepatitis B or C virus - Confirmed positive anti-HIV antibody test - Evidence of tuberculosis - Systemic or clinically significant infection - Clinically significant drug or alcohol abuse - Major surgical procedures within 12 weeks prior to study start - Pregnancy (BASEC)
Studienstandort
Bern, St Gallen, Zürich, Andere
(BASEC)
Buochs
(BASEC)
Sponsor
AbbVie Inc., North Chicago USA AbbVie AG, Cham, CH
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
21.08.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa (BASEC)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ein-/Ausschlusskriterien
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Ergebnisse der Studie
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