A Study of LAD191 in Adults With Hidradenitis Suppurativa
Key facts
- Where
- Barcelona, Granada, Madrid, Manises, and Sevilla, SpainSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07151937, who can take part
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainNo longer taking part
- Hospital de la Santa Creu i Sant PauBarcelona, SpainNo longer taking part
- Hospital Universitario Virgen de las NievesGranada, SpainNo longer taking part
- Hospital Universitario de la PrincesaMadrid, SpainNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainNo longer taking part
- Hospital de ManisesManises, SpainNo longer taking part
- Hospital Universitario Virgen De La MacarenaSevilla, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Almirall, S.A.
- Trial code
- NCT07151937EU 2025-521293-34-00
- Record updated
- 11 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment; Prior treatment with LAD191; Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study; Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required washout period for a particular prohibited medication prior to Baseline/Day 1; 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; HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit; Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.