A Study of LAD191 in Adults With Hidradenitis Suppurativa

Sponsor
Almirall, S.A.
Study ID
NCT07151937
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LAD191 — DRUG
    LAD191 subcutaneous injection.
  • Placebo — OTHER
    LAD191 Placebo subcutaneous injection.
  • Adalimumab — DRUG
    Adalimumab subcutaneous injection.

Study Details

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.

Key Dates

Start date
Nov 5, 2025
Status verified
Apr 2026
Primary completion
May 25, 2027
Completion
Nov 25, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LAD191 Dose A
    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.
  • Experimental: LAD191 Dose B
    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.
  • Experimental: LAD191 Dose C
    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.
  • Placebo Comparator: Placebo
    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.
  • Active Comparator: Adalimumab
    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.

Primary Outcome Measure

Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50) [ Time Frame: At Week 16 ]

Central Contacts

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