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Recruiting Phase 2

A Study of LAD191 in Adults With Hidradenitis Suppurativa

NCT07151937 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-11-05
Last updated
2026-05-11

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

LAD191PlaceboAdalimumab →

LAD191: LAD191 subcutaneous injection.

Placebo: LAD191 Placebo subcutaneous injection.

Adalimumab: Adalimumab subcutaneous injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 product information, and as per the Investigator's judgment. * 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. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed 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.

Primary outcome measure(s)

  • Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50) — At Week 16
    HiSCR-50 is defined as ≥50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline.

Trial sites (1)

FacilityCityRegionStatus
Hospital de Manises Manises Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07151937 on ClinicalTrials.gov ↗ ← All trials in Spain