A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa

NCT07547813 | Not Yet Recruiting Phase 2

• 2 other identifiers: M-00401-102025-521865-29-00
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to evaluate the effect of LAD328 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

Keywords

Hidradenitis; Skin Diseases; Infections

Outcome Measures

Primary Outcomes (1)

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

  IHS4 assigns different weights to different lesion types: inflammatory nodules (1 point), abscesses (2 points), and draining tunnels (4 points). The number of each lesion type is multiplied by its respective weight and the three obtained values are then summed to obtain the IHS4 total score. IHS4-55 is a dichotomous IHS4 variable based on a \>=55% reduction of the total score.

  At Week 12

Secondary Outcomes (5)

• Proportion of Participants Achieving 50% Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50)

  At Week 12

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

  At Week 12

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

  At Week 12

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

  At Week 12

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

  At Week 12

Study Arms (2)

LAD328

EXPERIMENTAL

Participants will receive LAD328 Dose A, intravenous (IV) infusion.

Drug: LAD328

Placebo

PLACEBO COMPARATOR

Participants will receive placebo diluent solution for IV infusion.

Other: Placebo

Interventions

LAD328 DRUG

LAD328 administered intravenously.

LAD328

Placebo OTHER

Placebo administered intravenously.

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female between 18 and 65 years old inclusive.
• 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 visits, with a clinical history 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 visits.
• History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit.
• Agree to regularly use, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study.
• Participants who are woman of child-bearing potential (WOCBP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD328 during the trial.

You may not qualify if:

• HS with \>20 draining tunnels either at the Screening or Baseline visits.
• Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial.
• Known or suspected hypersensitivity to trial product or any of its excipients.
• Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
• Prior treatment with LAD328.
• Live and attenuated vaccinations 4 weeks prior Pre-treatment or is planning to receive any such vaccine during the trial.
• Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.

Sponsors & Collaborators

• Almirall, S.A.: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis; Skin Diseases; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Central Study Contacts

Estrella Garcia

CONTACT

+34620985953; gco@almirall.com

Andrea Pejenaute

CONTACT

+34 697189586; apejenaute@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

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share