Find Hidradenitis Suppurativa Clinical Trials Near You
A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to assess the efficacy of multiple dosing regimens of LAD191 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 65 years.
• A diagnosis of moderate-to-severe HS defined as a total of \>= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months.
• HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits.
• History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit.
• Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study.
• Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study.
Locations
Other Locations
Spain
Hospital de Manises
RECRUITING
Manises
Contact Information
Primary
Victor Castellano
gco@almirall.com
+34932746671
Backup
Estrella García
gco@almirall.com
+34620985953
Time Frame
Start Date:2025-11-05
Estimated Completion Date:2027-11-25
Participants
Target number of participants:200
Treatments
Experimental: LAD191 Dose A
Participants will receive dose A LAD191 subcutaneous (SC) injection during both Treatment Period 1 and Treatment Period 2, unless if Dose A is eliminated after interim analysis, participants will receive the highest available dose of LAD191 during Treatment Period 2.
Experimental: LAD191 Dose B
Participants will receive dose B LAD191 SC injection during both Treatment Period 1 and Treatment Period 2, unless if Dose B is eliminated after interim analysis, participants will receive the highest available dose of LAD191 during Treatment Period 2.
Experimental: LAD191 Dose C
Participants will receive dose C LAD191 SC injection during both Treatment Period 1 and Treatment Period 2, unless if Dose C is eliminated after interim analysis, participants will receive the highest available dose of LAD191 during Treatment Period 2.
Placebo_comparator: Placebo
Participants will receive matching LAD191 placebo SC injection during Treatment Period 1 and will begin treatment with the highest available dose of LAD191 during Treatment Period 2.
Active_comparator: Adalimumab
Participants will receive adalimumab SC injection during Treatment Period 1 and will begin treatment with the highest available dose of LAD191 during Treatment Period 2.