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

A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD328 in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: LAD328; Other: Placebo

Detailed Description

Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects approximately 1% of the general population.

The purpose of this study is to assess the efficacy of LAD328 compared to placebo in participants with moderate-to-severe HS.

The study participants will be randomized to one of the following treatment arms: LAD328 or Placebo.

The study includes up to 4 weeks screening period 12-week double-blind, placebo-controlled period and 8-week safety follow-up.

The total duration of study participation will be up to 20 weeks

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Estrella Garcia; Phone Number: +34620985953; Email: gco@almirall.com
• Study Contact Backup: Name: Andrea Pejenaute; Phone Number: +34 697189586; Email: apejenaute@almirall.com

Study Locations

• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-953
      • Recruiting
      • Alm Site 1
      • Contact: Justyna Skibinska; Phone Number: 0048726101000; Email: recepcja@klinikaambroziak.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAD328; Participants will receive LAD328 Dose A, intravenous (IV) infusion.	Drug: LAD328; LAD328 administered intravenously.
Placebo Comparator: Placebo; Participants will receive placebo diluent solution for IV infusion.	Other: Placebo; Placebo administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving 50% Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50)	The HiSCR is defined as >=50% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.	At Week 12
Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75	The HiSCR is defined as >=75% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.	At Week 12
Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90	The HiSCR is defined as >=90% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.	At Week 12
Change from Baseline in Skin Pain Numerical Rating Scale (NRS)	Skin Pain NRS is an 11-point scale in which participants are asked to rate their skin pain over the prior 24 hours, where 0 is no skin pain and 10 is pain as bad as you can imagine.	At Week 12
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL)	HiSQOL was specifically developed for use in clinical trials and comprises a 17-item questionnaire grouped into 3 sub-scales covering symptoms, psychosocial, and activity-adaptation aspects, with a recall period of 7 days. Individual item scores are summed and a total score ranging from 0 to 68 is calculated, where the higher the score the more impact HS has on QoL.	At Week 12

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Investigators: Study Director: Study Director, Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Infections; Skin Diseases; Hidradenitis
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Hidradenitis; Infections; Skin Diseases
• Other Study ID Numbers: M-00401-10; 2025-521865-29-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No