Study on the Effects of Sonelokimab 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 study will evaluate a treatment called sonelokimab, which is given as a subcutaneous injection, meaning it is injected under the skin. Sonelokimab is a type of medication known as a nanobody that works by inhibiting proteins called IL-17A and IL-17F, which are involved in inflammation. The trial will compare the effects of sonelokimab with a placebo, which is a sterile solution that looks like the medication but does not contain any active ingredients.

The purpose of the study is to assess how effective and safe sonelokimab is for adults with moderate to severe hidradenitis suppurativa. Participants in the study will receive either sonelokimab or a placebo over a period of 16 weeks. During this time, researchers will monitor the participants to see if there is a 75% improvement in their condition, as measured by a specific score called the Hidradenitis Suppurativa Clinical Response (HiSCR) score. The study will also track any side effects or adverse events that occur during the treatment period.

Throughout the study, participants will undergo regular check-ups, including physical examinations and laboratory tests, to ensure their safety and to gather data on the treatment’s effects. The study aims to provide valuable information on whether sonelokimab can be a beneficial treatment option for those suffering from hidradenitis suppurativa.

1 joining the study

Upon joining the study, participants are required to provide informed consent, confirming their understanding and agreement to comply with the study requirements and restrictions.

2 initial assessment

Participants undergo an initial assessment to confirm eligibility, which includes a review of medical history and a physical examination.

Female participants of childbearing potential must have a negative pregnancy test before starting the study treatment.

3 randomization

Participants are randomly assigned to receive either the active medication, sonelokimab, or a placebo. The placebo is a sterile solution administered in the same manner as the active medication.

4 treatment phase

Participants receive subcutaneous injections of either sonelokimab or placebo. The treatment is administered over a period of 16 weeks.

The primary goal is to evaluate the improvement in the condition known as hidradenitis suppurativa, measured by a 75% improvement in the HiSCR score at Week 16.

5 monitoring and assessments

Throughout the study, participants are monitored for any side effects or adverse events. Regular assessments include physical examinations, vital signs, and laboratory tests.

Participants are also evaluated using various scales and questionnaires to assess the impact of the treatment on their quality of life and symptoms.

6 completion of treatment

At the end of the 16-week treatment period, participants undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.

Who Can Join the Study?

  • Participants must be at least 18 years old.
  • Participants need to complete at least 4 out of 7 days of electronic diary entries in at least 1 of the 2 weeks before joining the study.
  • Participants must have been diagnosed with hidradenitis suppurativa (HS) and have had signs and symptoms of HS for at least 6 months before joining the study.
  • Participants should have had an inadequate response to appropriate systemic antibiotics for treating HS, or they should have shown intolerance or had a reason not to use these antibiotics, as determined by the study doctor. Typically, this means they should have tried antibiotics for at least 8 to 12 weeks without success.
  • Participants in the antibiotic group must be on a stable dose, meaning their dose has not changed in the 28 days before starting the study treatment.
  • Female participants must not be pregnant or breastfeeding. They should either be unable to have children or agree to use highly effective birth control methods during the study and for at least 8 weeks after the last dose of study treatment. They must have a negative pregnancy test before starting the study.
  • Male participants must agree to use a condom when sexually active with a female partner who can have children during the study and for at least 8 weeks after the last dose of study treatment, unless they are surgically sterile.
  • Participants must be able to give signed informed consent, which means they understand and agree to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

  • Participants who do not have moderate to severe Hidradenitis Suppurativa (HS) cannot join the study. HS is a skin condition that causes small, painful lumps under the skin.
  • Participants who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants who belong to a vulnerable population, which means they might need special protection or care, are not eligible for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ICMR (International Center for Medical Research) Madrid Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
University Hospital Ostrava Ostrava Czechia
Hospital General Universitario De Valencia Valencia Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Centre Hospitalier Le Mans Le Mans France
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo Kielce Poland
Kožní ordinace Prague Czechia
Cxhfscake Unimipsqhhvdoc Szqmykjrm Woluwe-Saint-Lambert Belgium
Mkyfnoj Cnjwzp Hzhz Euvx Sofia Bulgaria
Uhxeymlnyst njhpbssrw Lo Pwexciee Kkeitn Kosice Slovakia
Civfnixnto Psndpmojtbk Lntewgqwczeabiwmujwfmhl Makszgbh sqcma Wroclaw Poland
Drkryojfcfmefduecncqvsj ctpita “jxkyxpqnddxyfzv Etiz Sofia Bulgaria
Fnehjyzz njlithuvz Mcrnp a Hhlpzxq Prague Czechia
Hvdspkke Cltgbv Dj Bfhybyufx Barcelona Spain
Czsptsc Ubogsbewwqyeyjdkdver Botxkc Kwg Berlin Germany
Ejiturj Uijeiegvqfjd Mrsnogt Cclvvgj Riltsetne (yaikfby Mds Rotterdam The Netherlands
Cnxdaq Hhuhxppwoep Undpkvjmjwhok Da Mmmhxfwxjbr Montpellier France
Uymjrzzytuyk Dv Sryzalgq Dm Ckvoknoizk Santiago De Compostela Spain
Uqtxdqjoldyjbnldramrk Wxwypwpfp Aos Wuerzburg Germany
Hbbljhw Pyazj D Atdyus Antony France
Pztyaem Svn z olrc Katowice Poland
Hpevbnpp Dk Lg Sgbpi Cgoh I Sfvv Pck Barcelona Spain
Su Vripawjqadztzkv Uaftconewf Huldvomw Dublin Ireland
Umnmypojkv Mymhsbf Cmdlbq Hjjgegggmqbuhscvx Hamburg Germany
Cqgdoh hinmzecpcaq uwiqkazzvruaj dq Lhdld Liege Belgium
Udsjifdmuvit Zyhgzhhyhr Gnnw Gent Belgium
Uqophhthkpgjggeknerwd Stftrmsaxqqulwmyqp Ank Kiel Germany
Ckzbta Hhdmmtfzpww Lppa Scj Pierre Benite France
Hddjbxzc Uhzanqklrfliy 1y Dk Owmgbai Madrid Spain
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Fturtpki Ndshdyxco Tmozpn Trnava Slovakia
Hvldzcvy Ufngoqtgloqqr Vxzxnb Dc Lcx Ntfhwm Granada Spain
Kczhpuj Aezzzqcnj Scy z ordh Warsaw Poland
Hblmevqw Uwzxwvqljhejq Vidjxv Dh Lr Vvhwgswj Malaga Spain
Dbqdipwmjv Mmunzvs Dovtpdvvumb Cmiiyp De Ne Mlgb Erydf Gcewsr Chorzow Poland
Izvhqjqw db Cryxsdudyijs Hoollpthekp Uipzibznjhnhr dr Shpoq Elsuaqe (qsdfafo Saint Priest En Jarez France
Dmdqoyijl Cndtcijo Dk Sshftbo Dm Sjldk Ddc Aozctr Toulon France
Ckdwzt Hxcgizekhep Uzsfopuotpxmv Do Dykvo Dijon France
Bnicympc Unborxeuqw Hsnfjapb Cirulm Besançon France
Sze Wackxvuthfmqd Gerd Gtru Gera Germany
Sgx Jomrbrghtobljr Bochum Germany
Hmkyikxt Uwbcnccvodqfi Ppzjyh Dje Mhd Cadiz Spain
Ukfapmzuvyunmtqryibop Aeonwzhd Augsburg Germany
Keebwfjp Dmgfoprvb Gkcn Darmstadt Germany
Txdkpxkyuui usu Svbyigkwcqh Bplcdtrh Gusd Bad Bentheim Germany
Ujhml &hvvhsj Pvqgx Dgc Sqdukt Kgwffyypk Ac Stara Zagora Bulgaria
Cxgqfgmv Rvtibmyj Cisffm Sep z owvw Mnjneli syppd Poznan Poland
Rumfhvgcx Rmdkqhtl Gfkv Darmstadt Germany
Hudgfcbz Gpcmjec Dz Ggyepjouar Granollers Spain
Kvpkdxvc Bpnfewgor ggoru Bielefeld Germany
Hdodclkr Ulyubzmrmfziu Hkxpuiei Twddx y Ppfyur Ispmcxla Caoeub dehcefpgljwirmbic (lhoc Badalona Spain
Myjapvx Cepzur Eauxpyyypp Eyor Sofia Bulgaria
Mvsgqyo Spjbjtw Zrutexrsq W Obqyyqbcl Olsztyn Poland
Spoyjq Colxrxw Anchybu Knsfjakpq Tvpfmk Kyalkoexipa &mcezlugtola Cmjlvtehqvejd Szczecin Poland
Hcgjgagctloxml al dkz homm Bramsche Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.09.2024
Bulgaria Bulgaria
Not recruiting
01.09.2024
Czechia Czechia
Not recruiting
01.09.2024
France France
Not recruiting
01.09.2024
Germany Germany
Not recruiting
01.09.2024
Ireland Ireland
Not recruiting
01.09.2024
Poland Poland
Not recruiting
01.09.2024
Slovakia Slovakia
Not recruiting
01.09.2024
Spain Spain
Not recruiting
01.09.2024
The Netherlands The Netherlands
Not recruiting
01.09.2024

Trial locations

Investigated Drugs:

Sonelokimab is a medication being studied for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. It is administered through an injection under the skin. The trial aims to see how well sonelokimab works in reducing the symptoms of this condition over a period of 16 weeks.

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. Over time, the condition can cause scarring and the development of more persistent lesions. The disease 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 a combination of genetic, hormonal, and environmental factors.

Trial ID:
2024-511363-28-00
Protocol code:
M1095-HS-302
Trial Phase:
Therapeutic confirmatory (Phase III)

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