Phase 2 Proof-of-Concept Study of LAD328 in Adults with Hidradenitis Suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Almirall S.A.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

30 Apr 2026 → ongoing

Decision date (initial)

2026-04-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Almirall S.A.

External identifiers

EU CT number

2025-521865-29-00

WHO UTN

U1111-1331-1731

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

- To evaluate the efficacy of LAD328 compared to placebo in patients with moderate-to-severe HS.
- To evaluate the safety and tolerability of LAD328.

Conditions and MedDRA coding

moderate-to-severe hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Male or female between 18 and 65 years old inclusive.
2. 2. A body mass index (BMI) of ≤40 kg/m2 and body weight of ≥45 kg at the time of signing the informed consent.
3. 3. Ability to understand and willing to comply with trial requirements as per Investigator’s opinion.
4. 4. Provide written informed consent in accordance with institutional and regulatory guidelines.
5. 5. A diagnosis of moderate-to-severe HS defined as a total of ≥5 inflammatory lesions (ie, 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.
6. 6. HS lesions present in at least 2 distinct anatomic areas (eg, 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.
7. 7. History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit, including participants who responded to course(s) of systemic antibiotic(s) and subsequently exhibited recurrence after discontinuation of the antibiotic, as assessed by the Investigator through trial participant interview and review of medical history.
8. 8. Agree to use, preferably daily but at least 3 days per week, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study from at least 2 weeks prior to the Baseline visit.
9. 9. 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 22

1. 1. Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment.
2. 10. Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment.
3. 11. History of malignancy within past 5 years prior to Baseline (other than successfully treated basal cell or squamous cell carcinoma of the skin), regardless of outcome.
4. 12. History of liver disease or clinically significant abnormal (as per judgment of Investigator) liver function test(s) at Screening.
5. 2. HS with >20 draining tunnels either at the Screening or Baseline visits.
6. 3. Presence of skin comorbidities that may interfere with trial assessments, in the opinion of the Investigator (eg, cystic acne, follicular pyodermas, bacterial cellulitis, actinomycosis, candida intertrigo and extensive condyloma).
7. 4. Surgical intervention for the treatment of HS within 3 months prior to Baseline.
8. 5. Ongoing medical conditions (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (eg, methotrexate, ciclosporin, corticosteroids, XXXX agents and JAK inhibitors) during the trial.
9. 6. Known or suspected hypersensitivity to trial product or any of its excipients.
10. 7. Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
11. 8. Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the trial participant’s ability to participate to comply with the trial requirements, as determined by the Investigator based on protocol required assessments.
12. 9. Active chronic or acute infection requiring treatment with systemic antimicrobials, antivirals, antiparasitic, antiprotozoals, or antifungals within 2 weeks before Baseline, or fever > 38°C during within 1 week before Baseline.
13. 13. Positive test result at Screening for hepatitis B surface antigen (HBsAg), or antibody to hepatitis B core antigen (anti-HBc antibody), or antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (anti-HIV-1/2 antibody).
14. 14. History within 1 year prior to Screening of alcohol or drug abuse, as per Investigator’s judgment.
15. 15. Major surgery (eg, open-heart surgery or organ transplant surgery) within the 3 months prior to the Baseline visit or has major surgery pre-planned for the time of participation in this trial at XXXX.
16. 16. Prior treatment with LAD328
17. 17. Live and attenuated vaccinations 4 weeks prior to XXXX or is planning to receive any such vaccine during the trial.
18. 18. Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required wash-out period for a particular prohibited medication prior to XXXX
19. 19. Inadequate response to 2 or more biologics for HS (eg, adalimumab, secukinumab and bimekizumab) having different MoAs (classes), as per the Investigator’s judgment.
20. 20. Females who are pregnant or breast-feeding or seeking to become pregnant during the trial or for approximately XXXX after the last dose of investigational medicinal product (IMP).
21. 21. Institutionalised because of legal or regulatory order.
22. 22. An employee or relative of the Sponsor, Clinical Research Organization (CRO) or other vendor, clinical trial site, or is an individual or employee otherwise directly involved with the conduct of the trial or is an immediate family member of such an individual.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Proportion of participants achieving IHS4-55 at XXXX.
2. Safety: Frequency and severity of TEAEs, SAEs, AESIs and AEs leading to discontinuation.
3. Safety: Vital signs, ECG and clinical laboratory parameters.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Almirall S.A.

Sponsor organisation

Almirall S.A.

Address

Ronda General Mitre 151

City

Barcelona

Postcode

08022

Country

Spain

Scientific contact point

Organisation

Almirall S.A.

Contact name

Estrella Garcia Alvarez

Public contact point

Organisation

Almirall S.A.

Contact name

Estrella Garcia Alvarez

Third parties 6

Locations

5 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications