A Study of LAD191 in Adults With Hidradenitis Suppurativa

NCT07151937 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: M-27134-102025-521293-34-00
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50)

  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.

  At Week 16

Secondary Outcomes (5)

• Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 at Week 16

  At Week 16

• Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 at Week 16

  At Week 16

• Proportion of Participants Achieving 55% Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) at Week 16

  At Week 16

• Change from Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16

  At Week 16

• Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Week 16

  At Week 16

Study Arms (5)

LAD191 Dose A

EXPERIMENTAL

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.

Drug: LAD191

LAD191 Dose B

EXPERIMENTAL

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.

Drug: LAD191

LAD191 Dose C

EXPERIMENTAL

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.

Drug: LAD191

Placebo

PLACEBO COMPARATOR

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.

Drug: LAD191; Other: Placebo

Adalimumab

ACTIVE COMPARATOR

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.

Drug: LAD191; Drug: Adalimumab

Interventions

LAD191 DRUG

LAD191 subcutaneous injection.

Adalimumab; LAD191 Dose A; LAD191 Dose B; LAD191 Dose C; Placebo

Placebo OTHER

LAD191 Placebo subcutaneous injection.

Placebo

Adalimumab DRUG

Adalimumab subcutaneous injection.

Adalimumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Central Study Contacts

Victor Castellano

CONTACT

gco@almirall.com

Estrella García

CONTACT

gco@almirall.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A double-blind, multiple-arm, adaptive treatment-selection designed study.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share