En studie för att undersöka effekt och säkerhet med SAR445399 hos vuxna deltagare med måttlig till svår hidrosadenit (CLAROS)
15 oktober 2026 uppdaterad av: Sanofi
En randomiserad, dubbelblind, placebokontrollerad, fas 2-studie med dosfindning för att undersöka effektiviteten och säkerheten hos SAR445399 hos deltagare med måttlig till svår hidrosadenit
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa.
The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.
The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.
Studieöversikt
Status
Status
Rekrytering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Studietyp
Studietyp
Interventionell
Inskrivning (Beräknad)
Inskrivning
144
Fas
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
Studiekontakt
- Namn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-post: Contact-US@sanofi.com
Studieorter
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Buenos Aires, Argentina, 1181
- Rekrytering
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1061
- Rekrytering
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1023
- Rekrytering
- Investigational Site Number : 0320001
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New South Wales
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Sydney, New South Wales, Australien, 2010
- Rekrytering
- Investigational Site Number : 0360001
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South Australia
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Woodville, South Australia, Australien, 5011
- Rekrytering
- Investigational Site Number : 0360003
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Western Australia
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South Perth, Western Australia, Australien, 6151
- Rekrytering
- Investigational Site Number : 0360002
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Brussels, Belgien, 1070
- Rekrytering
- Investigational Site Number : 0560002
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Ghent, Belgien, 9000
- Rekrytering
- Investigational Site Number : 0560001
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Liège, Belgien, 4000
- Rekrytering
- Investigational Site Number : 0560004
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São Paulo, Brasilien, 05651-901
- Rekrytering
- Hospital Israelita Albert Einstein- Site Number : 0760004
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 41820-020
- Rekrytering
- Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
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São Paulo
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Campinas, São Paulo, Brasilien, 13083-888
- Rekrytering
- Hospital das Clinicas da UNICAMP- Site Number : 0760002
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Lille, Frankrike, 59020
- Rekrytering
- Investigational Site Number : 2500005
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Lille, Frankrike, 59037
- Rekrytering
- Investigational Site Number : 2500006
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Nantes, Frankrike, 44093
- Rekrytering
- Investigational Site Number : 2500002
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Paris, Frankrike, 75010
- Rekrytering
- Investigational Site Number : 2500004
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Rouen, Frankrike, 76031
- Rekrytering
- Investigational Site Number : 2500003
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85260
- Rekrytering
- Scottsdale Clinical Trials- Site Number : 8400006
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California
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North Hollywood, California, Förenta staterna, 91606
- Aktiv, inte rekryterande
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
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Florida
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Boynton Beach, Florida, Förenta staterna, 33436
- Rekrytering
- Encore Medical Research of Boynton Beach- Site Number : 8400005
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Fort Lauderdale, Florida, Förenta staterna, 33308
- Rekrytering
- FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
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Fort Myers, Florida, Förenta staterna, 33912
- Rekrytering
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
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Hollywood, Florida, Förenta staterna, 33024
- Rekrytering
- Encore Medical Research - Hollywood- Site Number : 8400004
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Miami, Florida, Förenta staterna, 33173
- Rekrytering
- Florida International Research Center- Site Number : 8400002
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Miami, Florida, Förenta staterna, 33146
- Rekrytering
- Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
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Miami, Florida, Förenta staterna, 33174
- Rekrytering
- Florida Research Center- Site Number : 8400009
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Tampa, Florida, Förenta staterna, 33607
- Rekrytering
- Advanced Clinical Research Institute- Site Number : 8400021
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Georgia
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Cumming, Georgia, Förenta staterna, 30040
- Rekrytering
- Cleaver Medical Group Dermatology- Site Number : 8400008
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Fayetteville, Georgia, Förenta staterna, 30214
- Rekrytering
- First Georgia Physician Group- Site Number : 8400033
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Illinois
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Skokie, Illinois, Förenta staterna, 60077
- Rekrytering
- NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019
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Indiana
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Evansville, Indiana, Förenta staterna, 47708
- Rekrytering
- Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40241
- Rekrytering
- Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Rekrytering
- Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001
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Missouri
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Kansas City, Missouri, Förenta staterna, 64108
- Rekrytering
- University Health Dermatology- Site Number : 8400018
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New York
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The Bronx, New York, Förenta staterna, 10455
- Rekrytering
- Equity Medical (LLC)- Site Number : 8400010
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74137
- Rekrytering
- Essential Medical Research- Site Number : 8400015
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Texas
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The Woodlands, Texas, Förenta staterna, 77380
- Rekrytering
- Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
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Virginia
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Norfolk, Virginia, Förenta staterna, 23502
- Rekrytering
- Virginia Dermatology & Skin Cancer Center- Site Number : 8400024
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Brescia, Italien, 25123
- Rekrytering
- Investigational Site Number : 3800004
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Chieti, Italien, 66100
- Rekrytering
- Investigational Site Number : 3800001
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Pisa, Italien, 56126
- Rekrytering
- Investigational Site Number : 3800006
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Ancona
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Torette, Ancona, Italien, 60020
- Rekrytering
- Investigational Site Number : 3800002
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Ferrara
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Cona, Ferrara, Italien, 44124
- Rekrytering
- Investigational Site Number : 3800005
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Milano
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Garbagnate Milanese, Milano, Italien, 20024
- Rekrytering
- Investigational Site Number : 3800007
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Milan, Milano, Italien, 20132
- Rekrytering
- Investigational Site Number : 3800003
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Tokyo, Japan, 173-8610
- Rekrytering
- Investigational Site Number : 3920001
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Tokyo, Japan, 160-0023
- Rekrytering
- Investigational Site Number : 3920002
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 467-8602
- Rekrytering
- Investigational Site Number : 3920004
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Ibaraki
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Tsukuba, Ibaraki, Japan, 305-8576
- Rekrytering
- Investigational Site Number : 3920005
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Saitama
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Koshigaya, Saitama, Japan, 343-0845
- Rekrytering
- Investigational Site Number : 3920003
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Manitoba
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Winnipeg, Manitoba, Kanada, R3M 3Z4
- Rekrytering
- Investigational Site Number : 1240016
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Ontario
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Mississauga, Ontario, Kanada, L4W 0C2
- Rekrytering
- Investigational Site Number : 1240015
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Richmond Hill, Ontario, Kanada, L4B 1L1
- Rekrytering
- Investigational Site Number : 1240001
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Toronto, Ontario, Kanada, M2N 3A6
- Rekrytering
- Investigational Site Number : 1240014
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Quebec
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Montreal, Quebec, Kanada, H1Y 3L1
- Rekrytering
- Investigational Site Number : 1240010
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Sherbrooke, Quebec, Kanada, J1G 1X9
- Rekrytering
- Investigational Site Number : 1240002
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4V 1R9
- Rekrytering
- Investigational Site Number : 1240013
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Saskatoon, Saskatchewan, Kanada, S7K 0H6
- Rekrytering
- Investigational Site Number : 1240011
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Beijing, Kina, 100730
- Rekrytering
- Investigational Site Number : 1560001
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Changsha, Kina, 410011
- Rekrytering
- Investigational Site Number : 1560003
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Hangzhou, Kina, 310009
- Rekrytering
- Investigational Site Number : 1560006
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Shanghai, Kina, 200040
- Rekrytering
- Investigational Site Number : 1560004
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Wuhan, Kina, 430022
- Rekrytering
- Investigational Site Number : 1560002
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Córdoba, Spanien, 14004
- Rekrytering
- Investigational Site Number : 7240001
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Málaga, Spanien, 29016
- Rekrytering
- Investigational Site Number : 7240004
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Basque Country
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Bilbao, Basque Country, Spanien, 48013
- Rekrytering
- Investigational Site Number : 7240002
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Catalunya [Cataluña]
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Barcelona, Catalunya [Cataluña], Spanien, 08035
- Rekrytering
- Investigational Site Number : 7240006
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Sevilla
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Seville, Sevilla, Spanien, 41009
- Rekrytering
- Investigational Site Number : 7240005
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Uppsala, Sverige, 752 37
- Rekrytering
- Investigational Site Number : 7520002
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Örebro, Sverige, 701 85
- Rekrytering
- Investigational Site Number : 7520001
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Buca, Turkiet (Türkiye), 35390
- Rekrytering
- Investigational Site Number : 7920006
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Istanbul, Turkiet (Türkiye), 34093
- Rekrytering
- Investigational Site Number : 7920001
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Istanbul, Turkiet (Türkiye), 34899
- Rekrytering
- Investigational Site Number : 7920005
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Izmir, Turkiet (Türkiye), 35540
- Rekrytering
- Investigational Site Number : 7920004
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Manisa, Turkiet (Türkiye), 45030
- Rekrytering
- Investigational Site Number : 7920002
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Samsun, Turkiet (Türkiye), 55139
- Rekrytering
- Investigational Site Number : 7920003
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Blankenfelde-Mahlow, Tyskland, 15831
- Rekrytering
- Investigational Site Number : 2760004
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Darmstadt, Tyskland, 64283
- Rekrytering
- Investigational Site Number : 2760007
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Dresden, Tyskland, 01307
- Rekrytering
- Investigational Site Number : 2760006
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Merzig, Tyskland, 66663
- Rekrytering
- Investigational Site Number : 2760005
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Regensburg, Tyskland, 93053
- Rekrytering
- Investigational Site Number : 2760003
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Rostock, Tyskland, 18055
- Rekrytering
- Investigational Site Number : 2760002
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Budapest, Ungern, 1085
- Rekrytering
- Investigational Site Number : 3480002
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Gyula, Ungern, 5700
- Rekrytering
- Investigational Site Number : 3480005
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Kaposvár, Ungern, 7400
- Rekrytering
- Investigational Site Number : 3480003
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Szeged, Ungern, 6720
- Rekrytering
- Investigational Site Number : 3480004
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
- Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
- Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- History of recurrent or recent serious infection
- Known history of or suspected current immunosuppression
- History of solid organ transplant or stem cell transplant.
- History of splenectomy
- History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
- Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Antal vapen
3
Vapen och interventioner
Deltagargrupp / ArmDeltagargrupp / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Experimentell: SAR445399 dose regimen A
Participants will receive SAR445399 dose regimen A. |
Pharmaceutical form: Solution for injection -Route of administration: Injection |
|
Experimentell: SAR445399 dose regimen B
Participants will receive SAR445399 dose regimen B. |
Pharmaceutical form: Solution for injection -Route of administration: Injection |
|
Placebo-jämförare: Placebo
Participants will receive SAR445399-matching placebo. |
Pharmaceutical form: Solution for injection -Route of administration: Injection |
Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Tidsram: Up to Week 16
|
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count. |
Up to Week 16
|
Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procentuell förändring från baslinje till vecka 16 i antal dränerande tunnlar
Tidsram: Från baslinje till vecka 16
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Från baslinje till vecka 16
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Absolut förändring från baslinje till vecka 16 i antal dränerande tunnlar
Tidsram: Från baseline till vecka 16
|
Från baseline till vecka 16
|
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Procentuell förändring från baslinjen till vecka 16 i Hidradenitis Suppurativa Hudsmärta Numerisk Bedömningsskala (HS-Hudsmärta NRS)
Tidsram: Från baslinjen till vecka 16
|
Från baslinjen till vecka 16
|
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Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs) during the double- blinded initial treatment period and the treatment-blinded extension period
Tidsram: Up to End of Study (approximately 46 weeks)
|
Up to End of Study (approximately 46 weeks)
|
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Plasma concentrations of SAR445399 during the double-blinded initial treatment period and the treatment-blinded extension period
Tidsram: Up to End of Study (approximately 46 weeks)
|
Up to End of Study (approximately 46 weeks)
|
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Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints during the double-blinded initial treatment period and the treatment-blinded extension period
Tidsram: Up to End of Study (approximately 46 weeks)
|
Up to End of Study (approximately 46 weeks)
|
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Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Tidsram: Up to Week 16
|
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count) |
Up to Week 16
|
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Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
Tidsram: From baseline to Week 16
|
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease. |
From baseline to Week 16
|
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Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Tidsram: Up to Week 16
|
Hidradenitis Suppurativa Clinical Response 90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count. |
Up to Week 16
|
|
Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3
Tidsram: From baseline to Week 16
|
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). |
From baseline to Week 16
|
|
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
Tidsram: From Baseline to Week 16
|
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL. |
From Baseline to Week 16
|
|
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
Tidsram: From Baseline to Week 16
|
The Hidradenitis Suppurativa Quality of Life (HiSQoL) is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL. |
From Baseline to Week 16
|
|
Change from baseline to Week 16 in Weekly average HS-SAQ score items
Tidsram: From Baseline to Week 16
|
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Each item is scored on a 0 to 10 scale with 0 indicating "no symptom" and 10 indicating "worst symptom possible". |
From Baseline to Week 16
|
|
Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score
Tidsram: From Baseline to Week 16
|
The Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) is an 11-item questionnaire assessing the impact of HS on QoL |
From Baseline to Week 16
|
|
Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
Tidsram: From Baseline to Week 16
|
The Peak Pruritus Numerical Rating Scale (PP-NRS) is defined as achieving at least 4-unit reduction from Baseline in weekly average of daily PP-NRS among participants with baseline PP-NRS ≥4) |
From Baseline to Week 16
|
|
Number of participants with TEAEs AESIs, and SAEs including administration site reactions during the double-blinded initial treatment period and the treatment-blinded extension period
Tidsram: Up to End of Study (approximately 46 weeks)
|
Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs). |
Up to End of Study (approximately 46 weeks)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
Studiestart
29 december 2025
Primärt slutförande (Beräknad)
Primärt slutförande
22 september 2027
Avslutad studie (Beräknad)
Avslutad studie
19 november 2027
Studieregistreringsdatum
Först inskickad
Först inskickad
4 november 2025
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
4 november 2025
Första postat (Faktisk)
Första postat
6 november 2025
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
16 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2026
Senast verifierad
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
Andra studie-ID-nummer
- DRI20674
- 2025-522695-83-00 (Registeridentifierare: CTIS)
- U1111-1322-6148 (Annan identifierare: WHO-ICTRP)
- 2025 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .