A study to evaluate the effectiveness and safety of LAD328 in adults with moderate to severe hidradenitis suppurativa

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What is this study about?

This study focuses on adults living with Hidradenitis Suppurativa, a long-term skin condition that causes painful bumps, inflammation, and potentially deep tunnels or sores under the skin. The research aims to evaluate the efficacy and safety of a new medication called LAD328, which is a human IgG1 monoclonal antibody against interleukin 21. This type of medicine is a lab-made protein designed to target a specific part of the immune system to help control inflammation. The study will compare the effects of this treatment against a placebo consisting of sodium chloride.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medicine is delivered directly into the bloodstream through a needle in a vein. During the course of the study, the safety and how well the medication works will be closely monitored. This includes observing how the body reacts to the treatment and checking general health indicators such as heart rhythm and blood tests.

Who Can Join the Study?

You must be a male or female between the ages of 18 and 65.
Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be 40 or less, and you must weigh at least 45 kilograms.
You must be able to understand the study requirements and be willing to follow them.
You must provide written informed consent, which is a formal document where you agree to participate after being told all the details.
You must have been diagnosed with moderate-to-severe hidradenitis suppurativa (HS), a skin condition that causes painful lumps under the skin, for at least 6 months.
Your condition must involve at least 5 inflammatory lesions, which are painful bumps or pockets of infection, during both the initial check and the start of the study.
The skin lumps must be in at least 2 different body areas, such as both armpits.
At least one of these areas must be at a Hurley Stage II or III, which are levels used to describe the severity of the skin condition.
You must have a history of not responding well to systemic antibiotics, which are medicines taken by mouth or through a vein to treat infections, or you must be unable to take them due to side effects.
You must agree to use over-the-counter topical antiseptics, which are germ-killing liquids or creams applied directly to the skin, at least 3 days per week.
Women who may become pregnant and men must agree to follow specific rules to avoid pregnancy and prevent a partner from being exposed to the study medicine.

Who Cannot Join the Study?

Having syndromic HS, which means the skin condition is linked to genetic issues, problems with how hair follicles are formed, or an overactive immune system.
A history of a significant allergic reaction or body-wide reaction to a previous biologic therapy, which is a type of medicine made from living cells to target specific parts of the immune system.
Any physical or mental health condition that, in the doctor’s opinion, would make it difficult for you to follow all the rules and steps of the study.
Having an active infection (either long-term or sudden) that requires medicine like antibiotics (for bacteria), antivirals (for viruses), antiparasitics (for parasites), or antifungals (for fungus) within two weeks before the study starts, or having a fever higher than 38°C within one week before the study starts.
Testing positive for Hepatitis B, Hepatitis C, or HIV (a virus that affects the immune system).
A history of alcohol or drug abuse within the last year.
Having had major surgery, such as open-heart surgery or an organ transplant, in the three months before the study starts, or planning to have such surgery during the study.
Having used the study medication, LAD328, before.
Receiving live vaccines (vaccines that use a weakened form of a germ) within four weeks before the study starts or planning to get one during the study.
Planning to use any other medicines or treatments that are not allowed by the study rules, or not waiting long enough for a forbidden medicine to leave your system, a process known as a wash-out period.
Not getting enough improvement from two or more different types of biologics for your skin condition that work in different ways.
Having tuberculosis (an active infection or a past infection that is currently dormant), or testing positive for it.
Being pregnant, breastfeeding, or planning to become pregnant during the study or shortly after finishing the medicine.
Being living in an institution due to a legal or government order.
Being an employee or a close relative of the people or companies running the study.
A history of malignancy, which is a term for cancer, within the last five years, except for certain types of skin cancer that were successfully treated.
A history of liver disease or having abnormal results in blood tests that check how well your liver is working.
Having more than 20 draining tunnels (small passages under the skin that leak fluid) in your skin.
Having other skin conditions, such as severe acne or skin infections, that might make it hard for doctors to measure the study results.
Having surgery to treat your skin condition within three months before the study starts.
Having ongoing health conditions, such as inflammatory bowel disease or rheumatoid arthritis, that require medicines that suppress or change your immune system.
A known or suspected allergy to the study medicine or any of its excipients, which are the inactive ingredients used to make the medicine.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Beldio Research GmbH	Memmingen	Germany
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Medical Center Medconsult Burgas EOOD	Burgas	Bulgaria
Hms GmbH	Merzig	Germany
Labderm Essence Sp. z o.o.	Ozarowice	Poland
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
HIA Sainte Anne	Toulon	France
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
ASMC – IPSMC – Skin And Venereal Diseases	Sofia	Bulgaria
Courlancy Sante	Reims	France
Studiengesellschaft an der Hase GbR Dr. Weyergraf / Dr. Frick / Thomas Heiber	Bramsche	Germany
Mvxsetw Cjvoyd Mfolquxsjk Prbugo Ojk	Pleven	Bulgaria
Mubcskb Cprrxd Kzqart Ove	Pleven	Bulgaria
Psfofxyjp Irxaxnpu Morloeyk Myprzlqfpann Seryl Wsemoqtnbmwl I Anwcwmskehdkh	Warsaw	Poland
Dpnypgksos Swz z ozvf	Wroclaw	Poland
Fvkegtqfz Pbjn Le Ilgjpxxxemzwp Bqnqjsuzi Dge Hpvroqnz Uwyeixafwcpga Ly Pxa	Madrid	Spain
Hunimwfn Vlmx duupxjkc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	01.04.2026
France	Recruiting	01.04.2026
Germany	Recruiting	01.04.2026
Poland	Recruiting	01.04.2026
Spain	Recruiting	01.04.2026

Trial locations

Investigated drugs:

Sodium Chloride

LAD328 is an experimental treatment given through an IV infusion. It is designed to target and block a specific protein in the body called interleukin 21, which may help manage the inflammation associated with the condition being studied.

Investigated diseases:

Hidradenitis

Hidradenitis suppurativa – This is a chronic skin condition that primarily affects areas where skin rubs together, such as the armpits and groin. It begins with the formation of painful lumps under the skin. Over time, these lumps can rupture and release fluid or pus. As the condition progresses, it can lead to the development of tunnels or tracts under the skin. These tracts may eventually connect, creating complex networks of inflammation and scarring.

Trial ID:

2025-521865-29-00

Protocol code:

M-00401-10

Trial Phase:

Therapeutic exploratory (Phase II)

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A study to evaluate the effectiveness and safety of LAD328 in adults with moderate to severe hidradenitis suppurativa

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?