Study on Amlitelimab for Adults with Moderate to Severe Hidradenitis Suppurativa

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What is this study about?

This clinical trial is focused on studying a skin condition called hidradenitis suppurativa, which is a chronic inflammatory disease that causes painful lumps under the skin, often in areas like the armpits and groin. The trial is testing a new treatment called amlitelimab, which is given as a solution for injection under the skin. Amlitelimab is a type of protein designed to help reduce inflammation and improve symptoms in people with moderate to severe forms of this condition.

The purpose of the study is to evaluate how effective and safe amlitelimab is for treating hidradenitis suppurativa. Participants in the study will receive either amlitelimab or a placebo, which looks like the treatment but does not contain the active substance. The study will follow participants over a period of time to observe any changes in their condition and to monitor for any side effects. The main goal is to see if participants experience a reduction in the severity of their symptoms.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. This includes monitoring the number and size of skin lumps, as well as any changes in pain levels and overall quality of life. The study aims to provide valuable information on whether amlitelimab can be a beneficial treatment option for those suffering from hidradenitis suppurativa.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be between 18 and 70 years old and have a history of hidradenitis suppurativa (HS) for at least one year. HS lesions must be present in at least two distinct areas, with one area being classified as Hurley Stage II or III. An inadequate response to a 12-week trial of an oral antibiotic for HS is also required.

2 treatment administration

Participants receive a subcutaneous injection of either amlitelimab or a placebo. The placebo is a solution without the active substance but contains the same excipients as the test product. The injections are administered using a pre-filled syringe.

3 monitoring and assessments

Throughout the study, participants are monitored for clinical response and safety. The primary measure of success is the percentage of participants achieving a 50% reduction in HS symptoms by Week 16, known as HiSCR50.

Secondary assessments include the time to achieve HiSCR50, changes in lesion count, and improvements in quality of life and pain scores. Safety is evaluated through the incidence of adverse events and laboratory test results.

4 study duration

The study is expected to conclude by November 20, 2024. Participants are involved in the study from the start of recruitment, estimated to begin on February 1, 2024, until the end of the study period.

Who Can Join the Study?

  • Participant must be between 18 years (or the age of adulthood in their country if it’s older than 18) and 70 years old at the time of signing the consent form.
  • Participants should have had signs and symptoms of Hidradenitis for at least 1 year before starting the study. Hidradenitis is a skin condition that causes small, painful lumps under the skin.
  • Participants must have Hidradenitis lesions in at least 2 different body areas, such as both armpits or an armpit and the groin area. One of these areas must be classified as Hurley Stage II or Hurley Stage III, which are ways to describe the severity of the condition.
  • Participant must have tried taking an oral antibiotic for at least 12 weeks to treat Hidradenitis but did not have a good enough response.

Who Cannot Join the Study?

  • Participants who have a known allergy or sensitivity to the study medication or its ingredients.
  • Individuals with a history of severe allergic reactions, which are intense and potentially life-threatening responses by the body to certain substances.
  • Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
  • Individuals with a significant medical condition that could interfere with the study, such as uncontrolled diabetes or heart disease.
  • Women who are pregnant or breastfeeding, as the study medication may affect the baby.
  • Participants who have a history of drug or alcohol abuse, which means using these substances in a harmful way.
  • Individuals with a compromised immune system, meaning their body’s defense system is weakened and may not respond well to the study medication.
  • Patients who have had a major surgery within the last 3 months.
  • Individuals with a current or recent infection that requires treatment with antibiotics.
  • Participants who have received a live vaccine within the last 4 weeks. A live vaccine contains a small amount of the actual virus or bacteria to help the body build protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Royalderm Agnieszka Nawrocka Warsaw Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
St. Josef-Hospital Bochum Germany
Hospital De Santa Maria E.P.E. Lisbon Portugal
Hospital Cuf Descobertas S.A. Lisbon Portugal
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
University Of Debrecen Debrecen Hungary
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Semmelweis University Budapest Hungary
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Polyclinique Courlancy-Bezannes Reims France
University Of Szeged Szeged Hungary
Direction Centrale Du Service De Sante Des Armees Toulon France
Uwmmcbmfdbifdcaxoikxm Mqxpipcf Ahj Munster Germany
Pdoxjymqp Isjwqdxy Mknahqci Mbkjkuqpzhrl Syryc Whjymcrkwldr I Amkonvjgeazko Warsaw Poland
Gupsxm Uelndpiqnl Firlbsuaa Frankfurt Germany
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Hvaofgdi Uzevpamdubafh Hfzafkmi Txpbv y Pnbyha Ivlfukbr Cdtmnp dzhzsbonectxvuqif (tblb Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.02.2024
Germany Germany
Not recruiting
01.02.2024
Hungary Hungary
Not recruiting
01.02.2024
Italy Italy
Not recruiting
01.02.2024
Poland Poland
Not recruiting
01.02.2024
Portugal Portugal
Not recruiting
01.02.2024
Spain Spain
Not recruiting
01.02.2024

Trial locations

Investigated drugs:

Amlitelimab is a medication being studied for its potential to help people with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps under the skin. The trial aims to see how effective and safe this medication is for treating the symptoms of this condition.

Investigated diseases:

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of tunnels under the skin and scarring. The condition often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve hair follicles becoming blocked and inflamed. Factors such as genetics, hormones, and lifestyle may contribute to its development. The progression of the disease can vary, with some individuals experiencing mild symptoms and others having more severe and widespread involvement.

Trial ID:
2023-505803-22-00
Protocol code:
ACT17967
Trial Phase:
Therapeutic exploratory (Phase II)

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