Study on the Effects and Safety of SAR442970 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 characterized by painful lumps under the skin, often in areas like the armpits and groin. The trial is testing a new treatment called SAR442970, which is a type of protein designed to help reduce inflammation and improve symptoms in people with moderate to severe forms of this condition. The treatment is given as a solution for injection under the skin.

The purpose of the study is to evaluate how effective and safe SAR442970 is for people who have not previously used certain types of medications for their condition. Participants in the study will receive either the new treatment or a placebo, and neither the participants nor the researchers will know who is receiving which. 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 side effects.

Throughout the study, researchers will collect information on how well the treatment works in reducing the symptoms of hidradenitis suppurativa, such as the number of lumps and the level of skin pain. They will also monitor the safety of the treatment by checking for any adverse reactions. The study aims to provide valuable insights into whether SAR442970 can be a beneficial treatment option for people with this challenging skin condition.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Participants will be required to provide informed consent, indicating their understanding and agreement to participate in the study.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests. The assessment will ensure that participants meet the criteria for the study, such as having a history of hidradenitis suppurativa for at least one year and having specific types of lesions.

3 randomization

Participants will be randomly assigned to receive either the study medication, SAR442970, or a placebo. This process is double-blind, meaning neither the participants nor the researchers will know which treatment is being administered to ensure unbiased results.

4 treatment administration

Participants will receive the assigned treatment through subcutaneous injection. The frequency and dosage will be determined by the study protocol. Participants will be monitored for any immediate reactions to the injection.

5 regular follow-up visits

Participants will attend regular follow-up visits to monitor their health and the effects of the treatment. These visits will include physical examinations, laboratory tests, and assessments of hidradenitis suppurativa symptoms. Participants will be asked about any side effects or changes in their condition.

6 end of treatment period

At the end of the treatment period, participants will undergo a final assessment. This will include a comprehensive evaluation of their health and the effectiveness of the treatment. Participants will be informed about the next steps and any additional follow-up that may be required.

7 post-study follow-up

Participants may be contacted for post-study follow-up to gather information on long-term effects and overall health outcomes. This follow-up is important for understanding the lasting impact of the treatment.

Who Can Join the Study?

Participants must have a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year before starting the study.
Participants must have HS lesions in at least 2 different body areas (for example, left and right armpits, or left armpit and left groin area), with at least one area being classified as Hurley Stage II or Hurley Stage III.
Participants must have had an inadequate response to oral antibiotics for HS, experienced a return of symptoms after stopping antibiotics, shown intolerance to antibiotics, or have a reason they cannot take oral antibiotics, as determined by the study doctor through an interview and review of medical history.
Participants must be either new to biologic and small molecule immunosuppressive treatments or have experience with TNF treatments.
Participants must have a total count of abscesses and inflammatory nodules (AN) of 3 or more at the start of the study.
Participants must have a count of draining tunnels of 20 or fewer at the start of the study.
Participants must have a C-reactive protein (CRP) level greater than 3 mg/L at the screening visit. CRP is a substance in the blood that indicates inflammation.
Participants must be considered suitable for systemic treatment, which means treatment that affects the whole body, as judged by the study doctor.
Participants can be of any gender.
Participants must be within the age range specified for the study.

Who Cannot Join the Study?

Patients who have previously used biologic or small molecule immunosuppressive treatments cannot participate. These are special medications that affect the immune system.
Patients with any other medical condition that might interfere with the study results are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with a history of severe allergic reactions to any medication are excluded.
Patients with active infections or a history of certain infections may not participate.
Patients with a history of cancer, except for certain types of skin cancer, are not eligible.
Patients with significant liver or kidney disease cannot participate.
Patients with certain heart conditions are excluded from the study.
Patients who are unable to comply with the study procedures or follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland

Other Sites

Site Name	City	Country
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Hospices Civils De Lyon	Lyon	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
St. Josef-Hospital	Bochum	Germany
Staedtisches Klinikum Dessau	Dessau-Roßlau	Germany
Charite Research Organisation GmbH	Berlin	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Amphia Hospital	Breda	The Netherlands
Klinikum Darmstadt GmbH	Darmstadt	Germany
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Killasli Medical AB	Alvsjo	Sweden
Polyclinique Courlancy-Bezannes	Reims	France
University Hospital Ostrava	Ostrava	Czechia
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Zealand University Hospital	Koege	Denmark
Cxtqcphtb Uekihgrjtwbnvl Sytssogyg	Woluwe-Saint-Lambert	Belgium
Fvgqsswk nclobhxqz Mmvrv a Hpczjht	Prague	Czechia
Epxgyhw Ufowlyewbmfj Myxiwfr Cnjjuov Rguxbddms (glgxllo Mzu	Rotterdam	The Netherlands
Pddxswdyq Ifctklwn Mdsiycyx Mkpadjtkweur Sdffg Wkgvcuaahkwx I Arccxsderrwmg	Warsaw	Poland
Gdxlsr Uitngdzprg Fetdoxhnz	Frankfurt	Germany
Hfermrlk Db Le Ssssx Cfjp I Spyg Pfe	Barcelona	Spain
Umpnkyawzd Mhwpkan Cmpfuu Hackltwsmyuhtnoss	Hamburg	Germany
Unjwvwyfvtcr Mbmdzak Cxbtbru Gxyahpzwi	Groningen	The Netherlands
Fmbsmhgds Ptsj Ls Iswpvfufzpzqb Bgrommjlo Dmg Hdwcacdl Upkyxfbzmgxwd La Pyd	Madrid	Spain
Uhojkskfac Gtkdpfx Hgoaftpy Awubscf	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.05.2023
Czechia	Not recruiting	02.05.2023
Denmark	Not recruiting	02.05.2023
France	Not recruiting	02.05.2023
Germany	Not recruiting	02.05.2023
Greece	Not recruiting	02.05.2023
Italy	Not recruiting	02.05.2023
Poland	Not recruiting	02.05.2023
Spain	Not recruiting	02.05.2023
Sweden	Not recruiting	02.05.2023
The Netherlands	Not recruiting	02.05.2023

Trial locations

Investigated drugs:

Sar442970

SAR442970 is a special type of treatment called a NANOBODY® molecule. It is designed to help people with a skin condition known as hidradenitis suppurativa, which causes painful lumps under the skin. This medication works by targeting specific proteins in the body that are involved in inflammation, helping to reduce the symptoms and improve the condition of the skin. The goal of using SAR442970 in this trial is to see how effective it is in treating people who have not used other similar treatments before.

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 abscesses and tunnels under the skin. Over time, the condition can cause scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, where symptoms may temporarily improve. The exact cause of hidradenitis suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.

Trial ID:

2022-502370-17-00

Protocol code:

ACT16852

NCT ID:

NCT05849922

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of SAR442970 for Adults with Moderate to Severe Hidradenitis Suppurativa

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?