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Taking people in FrancePhase 2

A Study of LAD191 in Adults With Hidradenitis Suppurativa

Key facts

Who runs it
Almirall, S.A.
Where
Antony, Bordeaux, Le Mans Cedex 9, Lyon Cedex 03, Nantes, Paris, PARIS, and Rouen Cedex, FranceSee the 8 sitesAlso in 5 other countries, 29 sites
Status
Recruiting
Phase
Phase 2
People taking part
200 people, planned
Started
5 Nov 2025
Expected to end
25 Nov 2027
Type of study
Interventional, 5 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • LAD191
  • Placebo
  • Adalimumab
Record updated
11 May 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in France

Also in 5 other countries, 29 sites

  • Hopital Prive D AntonyAntony, FranceTaking people
  • Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
  • Centre Hospitalier Le MansLe Mans Cedex 9, FranceTaking people
  • Hospices Civils De LyonLyon Cedex 03, FranceTaking people
  • Hospital Hotel DieuNantes, FranceTaking people
  • Assistance Publique Hopitaux de ParisParis, FranceTaking people
  • Hopital Cochin - Port RoyalPARIS, FranceTaking people
  • Centre Hospitalier Universitaire RouenRouen Cedex, FranceTaking people

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • LAD191 Dose ATreatment being tested

    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.

    Treatment: LAD191

  • LAD191 Dose BTreatment being tested

    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.

    Treatment: LAD191

  • LAD191 Dose CTreatment being tested

    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.

    Treatment: LAD191

  • PlaceboPlacebo, for comparison

    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.

    Treatment: LAD191 and Placebo

  • AdalimumabExisting treatment, for comparison

    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.

    Treatment: LAD191 and Adalimumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Fit questions
Built from NCT07151937, who can take part
Record updated
11 May 2026