Hidradenitis Suppurativa: Lutikizumab in adult and adolescent patients with moderate to severe hidradenitis suppurativa
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Bern, St. Gallen, Zurich, Other
(BASEC)
Buochs
(BASEC)
Sponsor
AbbVie Inc., North Chicago USA AbbVie AG, Cham, CH
(BASEC)
Contact
Contact Person Switzerland
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
21.08.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
not available
Link to the results in the primary register
not available