Phase 2 Study of LAD191 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

9 Dec 2025 → ongoing

Decision date (initial)

2025-11-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Almirall S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Pharmacokinetic

- To assess the efficacy of multiple dosing regimens of LAD191 compared to placebo in patients with moderate-to-severe HS
- To assess the safety and tolerability of multiple dosing regimens of LAD191 in patients with moderate-to-severe HS

Conditions and MedDRA coding

Moderate-to-severe hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, provide written informed consent in accordance with institutional and regulatory guidelines
2. 2. Aged ≥18 to ≤65 years
3. 3. A BMI ≤40 kg/m2
4. 4. 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/Day 1 visits, with signs and symptoms of HS for at least 6 months
5. 5. 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/Day 1 visits
6. 6. History of inadequate response, 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 study participant interview and review of medical history
7. 7. Regular use of over-the-counter topical antiseptics on HS lesions for at least 2 weeks prior to Baseline/Day 1 visit and agrees to regular use, preferably daily but at least 3 days per week, throughout the entirety of the study
8. 8. 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

Exclusion criteria 25

1. 1. Presence of skin comorbidities that may interfere with study assessments, in the opinion of the Investigator (eg, cystic acne, follicular pyodermas, bacterial cellulitis, actinomycosis, candida intertrigo, extensive condyloma)
2. 2. HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit
3. 3. Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment
4. 4. Surgical intervention for the treatment of HS within 3 months prior to Baseline/Day 1
5. 5. Ongoing medical conditions (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis) requiring systemic
6. 6. Known hypersensitivity to LAD191 or any of its excipients
7. 7. 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
8. 8. Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator’s judgment
9. 9. Medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to comply with the study requirements, as determined by the Investigator based on protocol-specified assessments
10. 10. Active chronic or acute infection requiring systemic antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal treatment within 2 weeks before Baseline/Day 1, or fever ≥38°C within 1 week before Baseline/Day 1
11. 11. Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment
12. 12. Malignancy within past 5 years prior to Screening regardless of outcome, with the exception of successfully treated basal or squamous cell carcinoma of the skin
13. 13. History of liver disease or clinically significant abnormal (as per the Investigator’s judgment) liver function test(s) at Screening.
14. 14. 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)
15. 15. Neutrophil count <2.5×10^9/L at Screening
16. 16. History within 1 year prior to Screening of alcohol or drug abuse, as per the Investigator’s judgment
17. 17. History of major surgery (eg, open-heart surgery or organ transplant surgery) within the 3 months prior to the Baseline/Day 1 visit or has major surgery pre-planned for the time of participation in this study.
18. 18. Prior treatment with LAD191
19. 19. Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study
20. 20. Prior treatment with any anti-XXXXXX drug, whether investigational or any commercially available (eg, anakinra, canakinumab, or rilonacept), for any indication and did not respond adequately, as per the Investigator’s judgment.
21. 21. Inadequate response to two or more biologics for HS (eg, adalimumab, secukinumab, bimekizumab) having different MoAs (classes), as per the Investigator’s judgment.
22. 22. 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 (see Section 9.9.5.1).
23. 23. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
24. 24. Institutionalized because of legal or regulatory order.
25. 25. An employee or relative of the Sponsor, CRO, or other vendor, clinical trial site, or is an individual or employee otherwise directly involved with the conduct of the study 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 HiSCR 50
2. Safety endpoint: Frequency and severity of treatment-emergent AEs, SAEs, AEs leading to discontinuation, and AESIs
3. Safety endpoint: Local tolerance, vital signs, ECGs, and clinical laboratory parameters

Investigational products

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

Test 1

Comparator 2

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

Christine Roussarie

Public contact point

Organisation

Almirall S.A.

Contact name

Christine Roussarie

Third parties 10

Locations

6 EU/EEA countries · 37 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 58 files

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

Application history

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