A Study of LAD191 in Adults With Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlmirall, S.A.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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 product information, and as per the Investigator's judgment.
Trial design
Treatments tested in this trial
- LAD191
- Placebo
- Adalimumab
Treatment groups
200 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov