Hidradenitis Suppurativa: Lutikizumab in adult and adolescent patients with moderate to severe hidradenitis suppurativa
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Berne, St-Gall, Zurich, Autre
(BASEC)
Buochs
(BASEC)
Sponsor
AbbVie Inc., North Chicago USA AbbVie AG, Cham, CH
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date d'approbation du comité d'éthique
21.08.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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