A Study of Brivekimig Compared to Placebo in Patients with Moderate to Severe Hidradenitis Suppurativa

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What is this study about?

This study is being conducted for people with hidradenitis suppurativa, a long-term skin condition that causes painful lumps, abscesses (collections of pus under the skin), and tunnels that drain fluid under the skin, usually in areas where skin rubs together such as the armpits, groin, and under the breasts. The condition being studied ranges from moderate to severe forms. The treatment being tested in this study is called brivekimig, which is also known by its code name SAR442970. Some people in the study will receive brivekimig while others will receive placebo. The purpose of this study is to evaluate how well different doses of brivekimig work in treating people with moderate to severe hidradenitis suppurativa.

The study will test different amounts of brivekimig to find out which dose works best for treating the symptoms of hidradenitis suppurativa. Participants will receive the study treatment for a period of time, followed by a maintenance period where treatment continues. During the study, doctors will measure how much the skin condition improves by counting the number of abscesses and inflammatory nodules (swollen, painful bumps), as well as the number of draining tunnels (channels under the skin that leak fluid). They will also assess how the condition affects pain levels and quality of life. The study is designed so that neither the participants nor the doctors know who is receiving brivekimig and who is receiving placebo until the study is completed.

People taking part in this study must have been diagnosed with moderate to severe hidradenitis suppurativa for at least six months and must have lesions in at least two different body areas. They should have tried treatment with oral antibiotics that either did not work well enough, caused problems, or cannot be used for medical reasons. Participants may have never used biologic medications before, or they may have previous experience with them. Throughout the study, doctors will monitor participants for any side effects and will measure the levels of brivekimig in the blood to understand how the medication works in the body.

1 Initial treatment period

During this phase, you will receive either brivekimig or placebo (an inactive substance that looks like the actual treatment but contains no medication). This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving.

The study will test different dosing regimens (amounts and schedules) of brivekimig to determine which works best for treating hidradenitis suppurativa.

This initial treatment period will last until Week 16.

2 Assessment at Week 8

At Week 8, your skin pain will be assessed using the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale. This is a questionnaire where you will rate your pain level on a numbered scale.

This assessment helps determine if the treatment is reducing your pain symptoms.

3 Assessment at Week 16

At Week 16, several assessments will be performed to evaluate how well the treatment is working.

Your doctor will count the number of draining tunnels (channels under the skin that drain fluid) and compare this to the count at the beginning of the study.

Your disease severity will be measured using the International Hidradenitis Suppurativa Severity Score System, which is a standardized way to assess how severe your condition is.

You will complete questionnaires about your quality of life, including the Hidradenitis Suppurativa Quality of Life questionnaire and the Dermatology Life Quality Index. These help measure how the condition affects your daily activities and well-being.

Your doctor will assess your clinical response by measuring the reduction in abscesses (pus-filled lumps) and inflammatory nodules (swollen, painful lumps) compared to the start of the study.

4 Maintenance period

After the initial treatment period, you will enter a maintenance period where treatment continues.

The specific duration and dosing schedule for this phase will be determined based on the treatment group you are assigned to.

During this period, you will continue to receive the same treatment (either brivekimig or placebo) that you received during the initial phase.

5 Ongoing monitoring throughout the study

Throughout the entire study, your doctor will monitor you for any adverse events (unwanted or harmful reactions to the treatment).

Blood samples will be taken regularly to measure the amount of brivekimig in your bloodstream and to check for any laboratory abnormalities.

Your blood will also be tested to see if your body develops an immune response to brivekimig (antibodies against the medication).

The study is expected to continue until May 2028.

Who Can Join the Study?

You must have been diagnosed with moderate to severe hidradenitis suppurativa, which is a skin condition that causes painful lumps under the skin, for at least 6 months before starting the study
You must have hidradenitis suppurativa lesions, meaning affected areas of skin, in at least 2 different body areas, such as left and right armpit, or left armpit and left groin area, and one of these areas must be classified as Hurley Stage II or Hurley Stage III, which means moderate to severe disease
You must have previously tried treatment with an oral antibiotic, which is a medication taken by mouth to fight infection, and it either did not work well enough for you, your condition came back after stopping the antibiotic, you could not tolerate the antibiotic due to side effects, or you have a medical reason why you cannot take antibiotics for your condition
You may be someone who has never received biologic treatment before, which are medications made from living cells, or you may have used biologic treatments in the past
You must have at least 5 abscesses and inflammatory nodules in total at the start of the study, which are painful, swollen lumps filled with pus or fluid under the skin
You must have 20 or fewer draining tunnels at the start of the study, which are channels under the skin that leak fluid or pus
You can be male or female
You must be an adult to participate in this study

Who Cannot Join the Study?

The specific reasons why patients cannot participate in this study have not been provided in the available information
Generally, clinical trials have rules about who can join to ensure patient safety and study accuracy
These rules typically consider factors such as other health conditions, medications being taken, previous treatments, and test results
For this particular study, you would need to discuss with the study team to learn the complete list of reasons that would prevent participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Sanatorium profesora Arenbergera	Prague	Czechia
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Vita Verum Medical Bt.	Szekesfehervar	Hungary
Hospital Universitario Virgen De Las Nieves	Granada	Spain
CCR Ostrava s.r.o.	Moravska Ostrava A Privoz	Czechia
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Hopital Prive D Antony	Antony	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
University Of Debrecen	Debrecen	Hungary
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
University Of Pecs	Pecs	Hungary
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione Luigi Maria Monti	Rome	Italy
University Hospital Ostrava	Ostrava	Czechia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Courlancy Sante	Reims	France
Ixwyjs Irsdjhsp Fljuwxwnpzeei Ofzkjjpsgnp	Rome	Italy
Ukyokhkoclor Mcmzdao Cgnyjbk Ghhnkkquv	Groningen	The Netherlands
Uchxiolodvkhikphlfysl Mxtxhorl Aof	Munster	Germany
Pnaufljme Iihpgxwa Mbkujihc Mmfvatlyylre Sqbuw Wyzyhzkzwopn I Aoaaqixqhafda	Warsaw	Poland
Fonxzvqo nonlqmmgs Mgxlv a Hojvupk	Prague	Czechia
Fnnvpjxgv Pebq Lc Iydksxwvrexpn Bjhcnymav Dlw Hwvirrfy Urmrnjeblgqlo Lg Ppk	Madrid	Spain
Eafdrzp Usrlzvesicbk Mbpwxcy Cdfmivd Rfroqgivl (vclzydd Mlz	Rotterdam	The Netherlands
Uxyodsgkgdfvckoywragj Wxrbrniqc Asu	Wuerzburg	Germany
Ikaunsaj dc Cfdeuppxckcd Hipbwkohuwd Usysicddnmavo dg Sqjey Ebsyfoo (ynuidpq	Saint Priest En Jarez	France
Ghuiay Umstgzryuy Fpcsnksfg	Frankfurt	Germany
Dqyngitgryzfbme Punzou ad dtc Hvan	Bramsche	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	18.12.2025
France	Recruiting	18.12.2025
Germany	Recruiting	18.12.2025
Greece	Recruiting	18.12.2025
Hungary	Recruiting	18.12.2025
Italy	Recruiting	18.12.2025
Poland	Recruiting	18.12.2025
Spain	Recruiting	18.12.2025
The Netherlands	Not yet recruiting	18.12.2025

Trial locations

Brivekimig is an investigational medication being studied for the treatment of hidradenitis suppurativa, a chronic skin condition that causes painful lumps under the skin. This medication is being tested to see if it can help reduce the symptoms of moderate to severe forms of this condition. In this study, participants will receive brivekimig at different dose levels to determine which dosing approach works best.

A placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of brivekimig against no treatment, helping researchers understand if the medication is truly effective.

Hidradenitis Suppurativa – Hidradenitis suppurativa is a chronic skin condition that affects areas of the body where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. The disease begins with painful lumps under the skin that can become inflamed and may break open, releasing fluid or pus. Over time, these lumps can recur in the same areas and may lead to the formation of tunnels under the skin that connect the inflamed areas. The condition typically starts after puberty and can persist for many years with periods of flare-ups and remission. As the disease progresses, it may cause scarring and thick, rope-like scars in the affected areas. The repeated inflammation and healing process can significantly impact the skin’s appearance and cause ongoing discomfort.

Trial ID:

2025-522333-61-00

Protocol code:

DRI19220

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of Brivekimig Compared to Placebo in Patients with Moderate to Severe Hidradenitis Suppurativa

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?