Study of Eltrekibart for Adults with Moderate to Severe Hidradenitis Suppurativa

2 1

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, groin, and under the breasts. The study is specifically looking at adults with moderate to severe forms of this condition. The treatment being tested is a medication called Eltrekibart, which is a type of protein known as a monoclonal antibody. This protein is designed to target and block certain substances in the body that are involved in inflammation, potentially reducing the symptoms of Hidradenitis Suppurativa.

The purpose of the study is to determine if Eltrekibart is more effective than a placebo in improving the condition of participants with moderate to severe Hidradenitis Suppurativa. Participants in the study will receive either Eltrekibart or a placebo through a method called subcutaneous injection, which means the medication is injected under the skin. The study will last for a period of up to 50 weeks, during which participants will be monitored to see if there is an improvement in their symptoms.

Throughout the study, researchers will assess the participants’ response to the treatment by looking for a specific improvement known as the Hidradenitis Suppurativa Clinical Response 50 (HiSCR50). This measure indicates a significant reduction in the number of painful lumps and other symptoms. The study aims to provide valuable information on whether Eltrekibart can be a beneficial treatment option for people suffering from this challenging skin condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of hidradenitis suppurativa (HS) for at least 12 months, presence of HS lesions in at least two distinct anatomical regions, and an abscess plus inflammatory nodule count of at least five.

Participants must agree to use topical antiseptics daily and have had an inadequate response or intolerance to a 28-day course of oral antibiotics.

2 randomization and treatment allocation

Participants are randomly assigned to receive either the investigational drug eltrekibart or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

Eltrekibart is administered as a subcutaneous injection, which means it is injected under the skin.

3 treatment phase

During the treatment phase, participants receive the assigned treatment. The frequency and dosage of eltrekibart are determined by the study protocol, which is not specified in the provided data.

Participants are monitored regularly to assess the response to treatment and any potential side effects.

4 evaluation of primary endpoint

The primary endpoint is evaluated at week 16. This involves assessing the percentage of participants achieving a 50% reduction in HS symptoms, known as Hidradenitis Suppurativa Clinical Response 50 (HiSCR50).

This evaluation helps determine the effectiveness of eltrekibart compared to the placebo.

5 follow-up and study completion

After the treatment phase, participants may undergo follow-up assessments to monitor long-term effects and gather additional data.

The study is estimated to conclude by July 8, 2026, with recruitment starting on July 12, 2024.

Who Can Join the Study?

Must be an adult, meaning you are 18 years or older.
Must have been diagnosed with Hidradenitis Suppurativa (HS), a skin condition, for at least 12 months.
Must have HS lesions, which are affected areas on the skin, in at least 2 different body areas.
At least one of these lesions must be classified as Hurley Stage II or III, which are more advanced stages of the condition.
Must have a count of at least 5 for abscesses (swollen areas filled with pus) plus inflammatory nodules (small lumps under the skin).
Must agree to use topical antiseptics (medicines applied to the skin to prevent infection) every day.
Must have had an inadequate response or intolerance to a 28-day course of oral antibiotics, meaning the antibiotics did not work well or caused side effects.
Both males and females can participate.

Who Cannot Join the Study?

Individuals who do not have moderate to severe Hidradenitis Suppurativa cannot participate. Hidradenitis Suppurativa is a skin condition that causes small, painful lumps under the skin.
Participants must be adults, meaning they should be within the age range specified for adults in the study.
Both males and females are eligible, but if someone does not identify as either, they may not be able to participate.
People who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hautzentrum Friedrichshain	Berlin	Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
St. Josef-Hospital	Bochum	Germany
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.	Malbork	Poland
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR	Blankenfelde-Mahlow	Germany
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Pratia S.A.	Skorzewo	Poland
Usxavwpxkz Miajycb Cowwyc Hqzpthetpeitzfiuf	Hamburg	Germany
Uctnhileyt Gwbxzwx Hoamjbau Oh Hykmqqxji	Heraklion	Greece
Luqzzzm Sfrz Btjya Brirdyacazfmr Bbdlfgd Svykbuyvkbky	Ossy	Poland
Uqmwnvsfyxyzaddgylwyo Mzxsqytn Adu	Munster	Germany
Pthqqobof Iukvhwwd Mudwntpj Mswftaakynbg Shdmf Wnfbdhcwajbe I Awidsxztrmepj	Warsaw	Poland
Gvxkxu Ubscdlwjlz Fghcqaqny	Frankfurt	Germany
Uwildkucrnskmx Cgspwmj Knyhrargu	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	12.07.2024
Greece	Not recruiting	12.07.2024
Poland	Not recruiting	12.07.2024

Trial locations

Investigated drugs:

Humanised Igg4 Kappa Monoclonal Antibody Against Cxcl1, Cxcl2, Cxcl3, Cxcl5, Cxcl6, Cxcl7 And Cxcl8

Eltrekibart is a medication being tested to see if it can help people with moderate to severe Hidradenitis Suppurativa, a skin condition that causes painful lumps under the skin. The study aims to find out if this medication can improve the symptoms of the condition better than a placebo.

Investigated diseases:

Hidradenitis

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the development 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 abscesses and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not well understood, but it is believed to involve hair follicles becoming blocked and inflamed. It is more common in women and may be associated with other conditions like obesity and metabolic syndrome. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing significant pain and skin damage.

Trial ID:

2023-505608-43-00

Protocol code:

I7P-MC-DSAF

NCT ID:

NCT06046729

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Eltrekibart for Adults with Moderate to Severe Hidradenitis Suppurativa

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?