A Study of LAD191 in Adults With Hidradenitis Suppurativa (NCT07151937) | Clinical Trial Compass
RecruitingPhase 2
A Study of LAD191 in Adults With Hidradenitis Suppurativa
Spain200 participantsStarted 2025-11-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* HS with \>20 draining tunnels at the Screening or Baseline/Day 1 visit.
* Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study.
* Known hypersensitivity to LAD191 or any of its excipients.
* Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved prod…
What they're measuring
1
Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50)