En undersøgelse til at undersøge effektivitet og sikkerhed med SAR445389 hos voksne deltagere med moderat til svær hidradenitis suppurativa (CLAROS)
Et randomiseret, dobbeltblindt, placebokontrolleret, fase 2, dosisfindingsstudie til undersøgelse af effektiviteten og sikkerheden af SAR445399 hos deltagere med moderat til svær hidradenitis suppurativa
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-mail: Contact-US@sanofi.com
Studiesteder
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Buenos Aires, Argentina, 1181
- Rekruttering
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1061
- Rekruttering
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1023
- Rekruttering
- Investigational Site Number : 0320001
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New South Wales
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Sydney, New South Wales, Australien, 2010
- Rekruttering
- Investigational Site Number : 0360001
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South Australia
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Woodville, South Australia, Australien, 5011
- Rekruttering
- Investigational Site Number : 0360003
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Western Australia
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South Perth, Western Australia, Australien, 6151
- Rekruttering
- Investigational Site Number : 0360002
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Brussels, Belgien, 1070
- Rekruttering
- Investigational Site Number : 0560002
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Ghent, Belgien, 9000
- Rekruttering
- Investigational Site Number : 0560001
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Liège, Belgien, 4000
- Rekruttering
- Investigational Site Number : 0560004
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São Paulo, Brasilien, 05651-901
- Rekruttering
- 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
- Rekruttering
- 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
- Rekruttering
- Hospital das Clinicas da UNICAMP- Site Number : 0760002
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Rekruttering
- Investigational Site Number : 1240016
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Ontario
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Mississauga, Ontario, Canada, L4W 0C2
- Rekruttering
- Investigational Site Number : 1240015
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Richmond Hill, Ontario, Canada, L4B 1L1
- Rekruttering
- Investigational Site Number : 1240001
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Toronto, Ontario, Canada, M2N 3A6
- Rekruttering
- Investigational Site Number : 1240014
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Quebec
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Montreal, Quebec, Canada, H1Y 3L1
- Rekruttering
- Investigational Site Number : 1240010
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Sherbrooke, Quebec, Canada, J1G 1X9
- Rekruttering
- Investigational Site Number : 1240002
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Saskatchewan
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Regina, Saskatchewan, Canada, S4V 1R9
- Rekruttering
- Investigational Site Number : 1240013
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Saskatoon, Saskatchewan, Canada, S7K 0H6
- Rekruttering
- Investigational Site Number : 1240011
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85260
- Rekruttering
- Scottsdale Clinical Trials- Site Number : 8400006
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California
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North Hollywood, California, Forenede Stater, 91606
- Aktiv, ikke rekrutterende
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
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Florida
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Boynton Beach, Florida, Forenede Stater, 33436
- Rekruttering
- Encore Medical Research of Boynton Beach- Site Number : 8400005
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
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Fort Myers, Florida, Forenede Stater, 33912
- Rekruttering
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
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Hollywood, Florida, Forenede Stater, 33024
- Rekruttering
- Encore Medical Research - Hollywood- Site Number : 8400004
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Miami, Florida, Forenede Stater, 33173
- Rekruttering
- Florida International Research Center- Site Number : 8400002
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Miami, Florida, Forenede Stater, 33146
- Rekruttering
- Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
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Miami, Florida, Forenede Stater, 33174
- Rekruttering
- Florida Research Center- Site Number : 8400009
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Tampa, Florida, Forenede Stater, 33607
- Rekruttering
- Advanced Clinical Research Institute- Site Number : 8400021
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Georgia
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Cumming, Georgia, Forenede Stater, 30040
- Rekruttering
- Cleaver Medical Group Dermatology- Site Number : 8400008
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Fayetteville, Georgia, Forenede Stater, 30214
- Rekruttering
- First Georgia Physician Group- Site Number : 8400033
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Illinois
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Skokie, Illinois, Forenede Stater, 60077
- Rekruttering
- 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, Forenede Stater, 47708
- Rekruttering
- Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40241
- Rekruttering
- Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Rekruttering
- University Health Dermatology- Site Number : 8400018
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New York
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The Bronx, New York, Forenede Stater, 10455
- Rekruttering
- Equity Medical (LLC)- Site Number : 8400010
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74137
- Rekruttering
- Essential Medical Research- Site Number : 8400015
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Texas
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The Woodlands, Texas, Forenede Stater, 77380
- Rekruttering
- Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Virginia Dermatology & Skin Cancer Center- Site Number : 8400024
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Lille, Frankrig, 59020
- Rekruttering
- Investigational Site Number : 2500005
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Lille, Frankrig, 59037
- Rekruttering
- Investigational Site Number : 2500006
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Nantes, Frankrig, 44093
- Rekruttering
- Investigational Site Number : 2500002
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Paris, Frankrig, 75010
- Rekruttering
- Investigational Site Number : 2500004
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Rouen, Frankrig, 76031
- Rekruttering
- Investigational Site Number : 2500003
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Brescia, Italien, 25123
- Rekruttering
- Investigational Site Number : 3800004
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Chieti, Italien, 66100
- Rekruttering
- Investigational Site Number : 3800001
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Pisa, Italien, 56126
- Rekruttering
- Investigational Site Number : 3800006
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Ancona
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Torette, Ancona, Italien, 60020
- Rekruttering
- Investigational Site Number : 3800002
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Ferrara
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Cona, Ferrara, Italien, 44124
- Rekruttering
- Investigational Site Number : 3800005
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Milano
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Garbagnate Milanese, Milano, Italien, 20024
- Rekruttering
- Investigational Site Number : 3800007
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Milan, Milano, Italien, 20132
- Rekruttering
- Investigational Site Number : 3800003
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Tokyo, Japan, 173-8610
- Rekruttering
- Investigational Site Number : 3920001
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Tokyo, Japan, 160-0023
- Rekruttering
- Investigational Site Number : 3920002
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 467-8602
- Rekruttering
- Investigational Site Number : 3920004
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Ibaraki
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Tsukuba, Ibaraki, Japan, 305-8576
- Rekruttering
- Investigational Site Number : 3920005
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Saitama
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Koshigaya, Saitama, Japan, 343-0845
- Rekruttering
- Investigational Site Number : 3920003
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Beijing, Kina, 100730
- Rekruttering
- Investigational Site Number : 1560001
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Changsha, Kina, 410011
- Rekruttering
- Investigational Site Number : 1560003
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Hangzhou, Kina, 310009
- Rekruttering
- Investigational Site Number : 1560006
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Shanghai, Kina, 200040
- Rekruttering
- Investigational Site Number : 1560004
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Wuhan, Kina, 430022
- Rekruttering
- Investigational Site Number : 1560002
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Córdoba, Spanien, 14004
- Rekruttering
- Investigational Site Number : 7240001
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Málaga, Spanien, 29016
- Rekruttering
- Investigational Site Number : 7240004
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Basque Country
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Bilbao, Basque Country, Spanien, 48013
- Rekruttering
- Investigational Site Number : 7240002
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Catalunya [Cataluña]
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Barcelona, Catalunya [Cataluña], Spanien, 08035
- Rekruttering
- Investigational Site Number : 7240006
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Sevilla
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Seville, Sevilla, Spanien, 41009
- Rekruttering
- Investigational Site Number : 7240005
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Uppsala, Sverige, 752 37
- Rekruttering
- Investigational Site Number : 7520002
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Örebro, Sverige, 701 85
- Rekruttering
- Investigational Site Number : 7520001
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Buca, Tyrkiet (Türkiye), 35390
- Rekruttering
- Investigational Site Number : 7920006
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Istanbul, Tyrkiet (Türkiye), 34093
- Rekruttering
- Investigational Site Number : 7920001
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Istanbul, Tyrkiet (Türkiye), 34899
- Rekruttering
- Investigational Site Number : 7920005
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Izmir, Tyrkiet (Türkiye), 35540
- Rekruttering
- Investigational Site Number : 7920004
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Manisa, Tyrkiet (Türkiye), 45030
- Rekruttering
- Investigational Site Number : 7920002
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Samsun, Tyrkiet (Türkiye), 55139
- Rekruttering
- Investigational Site Number : 7920003
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Blankenfelde-Mahlow, Tyskland, 15831
- Rekruttering
- Investigational Site Number : 2760004
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Darmstadt, Tyskland, 64283
- Rekruttering
- Investigational Site Number : 2760007
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Dresden, Tyskland, 01307
- Rekruttering
- Investigational Site Number : 2760006
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Merzig, Tyskland, 66663
- Rekruttering
- Investigational Site Number : 2760005
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Regensburg, Tyskland, 93053
- Rekruttering
- Investigational Site Number : 2760003
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Rostock, Tyskland, 18055
- Rekruttering
- Investigational Site Number : 2760002
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Budapest, Ungarn, 1085
- Rekruttering
- Investigational Site Number : 3480002
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Gyula, Ungarn, 5700
- Rekruttering
- Investigational Site Number : 3480005
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Kaposvár, Ungarn, 7400
- Rekruttering
- Investigational Site Number : 3480003
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Szeged, Ungarn, 6720
- Rekruttering
- Investigational Site Number : 3480004
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: SAR445399 dose regimen A
Participants will receive SAR445399 dose regimen A. |
Pharmaceutical form: Solution for injection -Route of administration: Injection |
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Eksperimentel: SAR445399 dose regimen B
Participants will receive SAR445399 dose regimen B. |
Pharmaceutical form: Solution for injection -Route of administration: Injection |
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Placebo komparator: Placebo
Participants will receive SAR445399-matching placebo. |
Pharmaceutical form: Solution for injection -Route of administration: Injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Tidsramme: Up to Week 16
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Procentvis ændring fra baseline til uge 16 i antal drænerende tunneler
Tidsramme: Fra baseline til uge 16
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Fra baseline til uge 16
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Absolut ændring fra baseline til uge 16 i antallet af drænende tunneler
Tidsramme: Fra baseline til uge 16
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Fra baseline til uge 16
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Procentvis ændring fra baseline til uge 16 i Hidradenitis Suppurativa Hudsmerte Numerisk Vurderingsskala (HS-Skin Pain NRS)
Tidsramme: Fra baseline til uge 16
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Fra baseline til uge 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
Tidsramme: Up to End of Study (approximately 46 weeks)
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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
Tidsramme: Up to End of Study (approximately 46 weeks)
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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
Tidsramme: Up to End of Study (approximately 46 weeks)
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Up to End of Study (approximately 46 weeks)
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Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Tidsramme: Up to Week 16
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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)
Tidsramme: From baseline to Week 16
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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)
Tidsramme: Up to Week 16
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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
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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
Tidsramme: From baseline to Week 16
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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
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Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
Tidsramme: From Baseline to Week 16
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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
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Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
Tidsramme: From Baseline to Week 16
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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
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Change from baseline to Week 16 in Weekly average HS-SAQ score items
Tidsramme: From Baseline to Week 16
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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
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Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score
Tidsramme: From Baseline to Week 16
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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
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Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
Tidsramme: From Baseline to Week 16
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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
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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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DRI20674
- 2025-522695-83-00 (Registry Identifier: CTIS)
- U1111-1322-6148 (Anden identifikator: WHO-ICTRP)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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