Study on Izokibep for Patients 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 characterized by painful lumps under the skin, often in areas like the armpits and groin. The study is testing a treatment called Izokibep, which is given as an injection under the skin. The purpose of the study is to evaluate how effective and safe Izokibep is for people with moderate to severe forms of this condition.

Participants in the study will be randomly assigned to receive either Izokibep or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for several weeks, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any changes in their condition. The main goal is to see if the treatment helps reduce the symptoms of Hidradenitis Suppurativa by a significant amount by the end of the study period.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to provide valuable information on whether Izokibep can be a beneficial treatment option for those suffering from this challenging skin condition.

1 enrollment and randomization

Upon joining the study, the participant is enrolled and randomly assigned to receive either izokibep or a placebo. This process ensures that the study results are unbiased and reliable.

2 treatment administration

The participant receives the assigned treatment, which is administered as a solution for injection under the skin (subcutaneous injection).

The treatment involves the use of izokibep, a medication being tested for its effectiveness in treating moderate to severe hidradenitis suppurativa, or a placebo, which is an inactive substance used for comparison.

3 treatment duration

The treatment is administered over a period leading up to Week 12. During this time, the participant continues to receive the injections as per the study schedule.

4 evaluation of treatment efficacy

The primary goal is to assess the effectiveness of izokibep by measuring the percentage of participants achieving a significant reduction in symptoms, known as HiSCR75, at Week 12.

Secondary evaluations include achieving HiSCR90 and HiSCR100, monitoring for any flares, and assessing changes in skin pain and quality of life.

5 safety monitoring

Throughout the study, the participant’s health is closely monitored. This includes tracking any adverse events, changes in laboratory values, and vital signs to ensure the safety of the treatment.

6 study completion

The study is expected to conclude by December 17, 2025. At this point, all data collected will be analyzed to determine the overall efficacy and safety of izokibep in treating hidradenitis suppurativa.

Who Can Join the Study?

The person must be at least 18 years old or the legal age of consent in their area when they sign the consent form.
The person must have Hidradenitis Suppurativa lesions in at least two different body areas, such as both armpits or one 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.
The person must have a total count of at least 5 AN (abscesses and nodules) at the time of screening and on the first day before joining the study.
The person must have tried oral antibiotics for at least 3 months to treat their condition and found them not effective, or they had a return of symptoms after stopping the antibiotics, or they could not tolerate them, or they have a medical reason not to use them, as determined by the study doctor after talking with the person and reviewing their medical history.
The person must have a negative TB (tuberculosis) test at the time of screening.

Who Cannot Join the Study?

Patients who have a different skin condition other than Hidradenitis Suppurativa cannot participate. Hidradenitis Suppurativa is a long-term skin condition that causes small, painful lumps under the skin.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have a known allergy to the study medication cannot participate.
Patients who have a serious infection or illness cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
HIA Sainte Anne	Toulon	France
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Saint Joseph	Marseille	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Medizinisches Versorgungszentrum DermaKiel GmbH	Kiel	Germany
Hospital De Manises	Manises	Spain
University Of Debrecen	Debrecen	Hungary
Obudai Egeszsegugyi Centrum Kft.	Zalaegerszeg	Hungary
Hospital Universitario Virgen Macarena	Sevilla	Spain
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Centre Hospitalier Universitaire De Nantes	Nantes	France
St. Josef-Hospital	Bochum	Germany
Hospital Edouard Herriot	Lyon	France
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Malopolskie Centrum Kliniczne	Cracow	Poland
Rosenpark Research GmbH	Darmstadt	Germany
Labderm Essence Sp. z o.o.	Ozarowice	Poland
Djhxjrblxm Snq z opgp	Wroclaw	Poland
Cnotrso Zfxoipx Dmwlmnk I Rnuoycu Iat Jkce Pevcx Ix W Sfdklpit Sgu z ovbk	Sosnowiec	Poland
Ptdvfbk Ssg z ovbs	Katowice	Poland
Dmaifbeuprbg Qypbj	Mainz	Germany
Cnlvxm Hqkiukryjvy Ulfcwtnhafptt Dy Dvdib	Dijon	France
Gwzmvc Uccynkdprj Fyraaawkg	Frankfurt	Germany
Hiamcjow Do Lg Sjzvo Cjel I Sbrk Pyh	Barcelona	Spain
Uqxpjbljcp Mavqfzy Cquakf Hjbfcvjfkptcdtsrv	Hamburg	Germany
Tfdxwkjebfd ugx Sfhvthxyggq Bpbwyeml Gbpk	Bad Bentheim	Germany
Hqsmtqns Udkcdifkgorei Hvymjqma Tfkce y Pcbfpi Iiwxqpvo Cekhxa dxhtzphjbxcvzeuji (zfsy	Badalona	Spain
Llmmgfu Sohqjbkfangbnhb Gifgoxr Doyqwpsrxkxazwx	Lublin	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	06.12.2023
Germany	Not recruiting	06.12.2023
Hungary	Not recruiting	06.12.2023
Poland	Not recruiting	06.12.2023
Spain	Not recruiting	06.12.2023

Trial locations

Investigated drugs:

Izokibep

Izokibep is a medication being studied for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition characterized by painful lumps under the skin. The trial aims to determine how well izokibep works in reducing the symptoms of this condition by comparing it to a placebo.

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 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 not contagious and varies in severity from person to person.

Trial ID:

2022-503160-33-00

Protocol code:

22107

NCT ID:

NCT05905783

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Izokibep for Patients with Moderate to Severe Hidradenitis Suppurativa

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