Clinical trial • Phase II • Dermatology
LAD191 for Hidradenitis suppurativa
Phase II trial of LAD191 for Hidradenitis suppurativa.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Hidradenitis suppurativa
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme|Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 10-07-2025
- First CTIS Authorization Date
- 03-11-2025
Trial design
Randomised, active comparator: adalimumab (adalimumab) — solution for injection, subcutaneous use. placebo: lad191 placebo. comparator/control solution: sodium chloride (sodium chloride) — solution for injection, subcutaneous use. dose and schedule not specified in provided ctis record., adaptive Phase II trial in France, Germany, Ireland and others.
- Randomised
- Yes
- Comparator
- Active comparator: Adalimumab (ADALIMUMAB) — solution for injection, subcutaneous use. Placebo: LAD191 placebo. Comparator/control solution: Sodium chloride (SODIUM CHLORIDE) — solution for injection, subcutaneous use. Dose and schedule not specified in provided CTIS record.
- Adaptive
- True, multiple-arm, multiple-stage adaptive design is stated (seamless Phase 2a/2b, multiple-stage adaptive). Specific adaptive elements (e.g. interim analyses, stopping rules, dose-escalation rules) are not detailed in the provided record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 25
Eligibility
Recruits 25 Vulnerable populations not selected (isVulnerablePopulationSelected=false). Participants must provide written informed consent; no assent procedures described. Trial enrols adults aged ≥18 to ≤65 years..
- Pregnancy Exclusion
- 23. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- Vulnerable Population
- Vulnerable populations not selected (isVulnerablePopulationSelected=false). Participants must provide written informed consent; no assent procedures described. Trial enrols adults aged ≥18 to ≤65 years.
Inclusion criteria
- {"criterion_text":"- 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\n- 2. Aged ≥18 to ≤65 years\n- 3. A BMI ≤40 kg/m2\n- 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\n- 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\n- 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\n- 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\n- 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
- {"criterion_text":"- 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)\n- 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\n- 11. Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment\n- 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\n- 13. History of liver disease or clinically significant abnormal (as per the Investigator’s judgment) liver function test(s) at Screening.\n- 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)\n- 15. Neutrophil count <2.5×10^9/L at Screening\n- 16. History within 1 year prior to Screening of alcohol or drug abuse, as per the Investigator’s judgment\n- 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.\n- 18. Prior treatment with LAD191\n- 19. Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study\n- 2. HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit\n- 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.\n- 21. Inadequate response to two or more biologics for HS (eg, adalimumab, secukinumab, bimekizumab) having different MoAs (classes), as per the Investigator’s judgment.\n- 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).\n- 23. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n- 24. Institutionalized because of legal or regulatory order.\n- 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.\n- 3. Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment\n- 4. Surgical intervention for the treatment of HS within 3 months prior to Baseline/Day 1\n- 5. Ongoing medical conditions (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis) requiring systemic\n- 6. Known hypersensitivity to LAD191 or any of its excipients\n- 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\n- 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\n- 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants achieving HiSCR 50","definition_or_measurement_approach":""}
- {"endpoint_text":"- Safety endpoint: Frequency and severity of treatment-emergent AEs, SAEs, AEs leading to discontinuation, and AESIs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Safety endpoint: Local tolerance, vital signs, ECGs, and clinical laboratory parameters","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 25
- Recruitment Window Months
- 21
- Consent Approach
- Written informed consent is required from each participant in accordance with institutional and regulatory guidelines. Participant information and ICF documents are available in multiple country/language versions (examples in CTIS: Polish, French, English, Italian, Spanish, German). Participants must be able to provide written informed consent; no assent procedures described (adult-only population, aged ≥18 to ≤65). Additional country-specific ICF variants (e.g. Pregnancy partner, optional research consents) are provided.
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 128
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 107
- Number Of Sites
- 8
- Number Of Participants
- 27
Sites
- Site Name
- Hopital Cochin - Port Royal
- Department Name
- Dermatology
- Contact Person Name
- Bénédicte Oules
- Contact Person Email
- benedicte.oules@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Dermatology
- Contact Person Name
- Anne-Bénédicte Duval-Modeste
- Contact Person Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Dermatology
- Contact Person Name
- Nathalie Beneton
- Contact Person Email
- nbeneton@ch-lemans.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Dermatology
- Contact Person Name
- Axel Villani
- Contact Person Email
- Axel.villani@chu-lyon.fr
- Site Name
- Hopital Prive D Antony
- Department Name
- Dermatology
- Contact Person Name
- Pierre-André Becherel
- Contact Person Email
- p.becherel@ramsaygds.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Dermatology
- Contact Person Name
- Olivier Cogrel
- Contact Person Email
- olivier.cogrel@chu-bordeaux.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Dermatology
- Contact Person Name
- Marie Le Moigne
- Contact Person Email
- marie.lemoigne@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology
- Contact Person Name
- Charles Cassius
- Contact Person Email
- charles.cassius@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 189
- Number Of Sites
- 9
- Number Of Participants
- 27
Sites
- Site Name
- St. Josef-Hospital
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Contact Person Name
- Falk Bechara
- Contact Person Email
- f.bechara@klinik
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Dermatology
- Contact Person Name
- Caroline Mann
- Contact Person Email
- caroline.mann@unimedizin-mainz.de
- Site Name
- Rosenpark Research GmbH
- Contact Person Name
- Oliver Weirich
- Contact Person Email
- Oliver.weirich@rosenparkresearch.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie (KVDA)
- Contact Person Name
- Andreas Pinter
- Contact Person Email
- Pinter-Klifo-Ffm@gmx.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Dermatology
- Contact Person Name
- Dagmar Presser
- Contact Person Email
- Presser_D1@ukw.de
- Site Name
- BAG Dres. med. Quist PartG
- Contact Person Name
- Sven Quist
- Contact Person Email
- studie@dermatologie-quist.de
- Site Name
- Magdeburger Company For Medical Studies & Services GmbH
- Contact Person Name
- Jens-Joachim Bruecher
- Contact Person Email
- bruecher@dermacare.md
- Site Name
- Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
- Contact Person Name
- Michael Sebastian
- Contact Person Email
- m.sebastian@derma-mahlow.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie Zentrum für entzündliche Hauter
- Contact Person Name
- Sascha Gerdes
- Contact Person Email
- sgerdes@dermatology.uni-kiel.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 113
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- St Vincent's University Hospital
- Department Name
- Dermatology
- Contact Person Name
- Brian Kirby
- Contact Person Email
- bkirby@svhg.ie
- Site Name
- Our Lady Of Lourdes Hospital
- Department Name
- Dermatology
- Contact Person Name
- Niamh Kearney
- Contact Person Email
- Niamh.kearney2@hse.ie
Italy
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 263
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- University Hospital Of Ferrara
- Department Name
- Dermatologia
- Contact Person Name
- Alessandro Borghi
- Contact Person Email
- brglsn1@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Dermatologia
- Contact Person Name
- Marco Romanell
- Contact Person Email
- marco.romanelli@unipi.it
- Site Name
- Azienda USL Toscana Centro
- Department Name
- Dermatologia
- Contact Person Name
- Francesca Prignano
- Contact Person Email
- francesca.prignano@unifi.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Dermatologia
- Contact Person Name
- Simone Ribero
- Contact Person Email
- simone.ribero@unito.it
Spain
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 189
- Number Of Sites
- 7
- Number Of Participants
- 27
Sites
- Site Name
- Hospital De Manises
- Department Name
- Dermatology
- Contact Person Name
- Antonio Jaime Martorell Calatayud
- Contact Person Email
- martorelldermatologia@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Dermatology
- Contact Person Name
- Irene Fuertes de Vega
- Contact Person Email
- IFUERTES@clinic.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Contact Person Name
- Eva Vilarrasa Rull
- Contact Person Email
- evilarrasa@santpau.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Dermatology
- Contact Person Name
- Lara Ferrandiz Pulido
- Contact Person Email
- lara.ferrandiz.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Dermatology
- Contact Person Name
- Daniella Paz Cullen Aravena
- Contact Person Email
- dcullen@quironsalud.es
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Dermatology
- Contact Person Name
- Yolanda Delgado-Jimenez
- Contact Person Email
- ydelgado@aedv.es
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Dermatology
- Contact Person Name
- Alejandro Molina Leyva
- Contact Person Email
- alejandromolinaleyva@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 16
- Number Of Sites
- 7
- Number Of Participants
- 27
Sites
- Site Name
- Dermoklinika Centrum Medyczne s.c. M. Kierstan. J. Narbutt , A. Lesiak
- Contact Person Name
- Joanna Narbutt
- Contact Person Email
- joanna.narbutt@onet.pl
- Site Name
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
- Contact Person Name
- Jacek Szepietowski
- Contact Person Email
- jacek.szepietowski.work@gmail.com
- Site Name
- Pratia S.A.
- Contact Person Name
- Kamila Płaczek
- Contact Person Email
- kamilaplaczek@interia.pl
- Site Name
- Dermedic Jacek Zdybski
- Contact Person Name
- Piotr Parcheta
- Contact Person Email
- piotr.parcheta@zdybski.pl
- Site Name
- Royalderm Agnieszka Nawrocka
- Contact Person Name
- Witold Owczarek
- Contact Person Email
- kontakt@royalderm.pl
- Site Name
- Nuvamed Sp. z o.o.
- Contact Person Name
- Katarzyna Łuczak
- Contact Person Email
- luczak.kas@gmall.com
- Site Name
- Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
- Department Name
- Ośrodek Badań Klinicznych
- Contact Person Name
- Hubert Arasiewicz
- Contact Person Email
- hubert.arasiewicz@gmail.com
Sponsor
Primary sponsor
- Full Name
- Almirall S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Contract research organisations
- Name
- EndPoint
- Responsibilities
- sponsorDuties codes: 3
- Name
- Fortrea Inc.
- Responsibilities
- sponsorDuties codes: 1,12,13,2,5,8
- Name
- Cytel Inc.
- Responsibilities
- sponsorDuties codes: 10,6 (statistical/other operational duties)
- Name
- Clario
- Responsibilities
- sponsorDuties codes: 15 (Doppler, ECG)
- Name
- Veeva Systems Inc.
- Responsibilities
- sponsorDuties codes: 15 (eCOA), 7
Third parties
- {"country":"United States","full_name":"EndPoint","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Industry"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"sponsorDuties codes: 10, 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsorDuties codes: 15 (Blood PK & ADA Central lab analysis)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario (Princeton)","duties_or_roles":"sponsorDuties codes: 15 (Doppler)","organisation_type":"Health care"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: 15 (eCOA), 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"University Of Michigan","duties_or_roles":"sponsorDuties codes: 15 (Skin Biopsy Central lab analysis)","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Clario (Philadelphia)","duties_or_roles":"sponsorDuties codes: 15 (ECG)","organisation_type":"Health care"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: 1,12,13,2,5,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- LAD191
- Active Substance
- LAD191
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- LAD191 placebo
- Modality
- Other
- Investigational Product Name
- ADALIMUMAB
- Active Substance
- Adalimumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- Sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
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