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Uno studio per valutare l'efficacia e la sicurezza di SAR445399 in partecipanti adulti con idrosadenite suppurativa da moderata a grave (CLAROS)

15 ottobre 2026 aggiornato da: Sanofi

Studio randomizzato, in doppio cieco, controllato con placebo, di fase 2, per la determinazione della dose, volto a valutare l'efficacia e la sicurezza di SAR445399 in partecipanti affetti da idrosadenite suppurativa da moderata a grave

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

144

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Trial Transparency email recommended (Toll free for US & Canada)
  • Numero di telefono: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Reclutamento
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentina, 1061
        • Reclutamento
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1023
        • Reclutamento
        • Investigational Site Number : 0320001
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Reclutamento
        • Investigational Site Number : 0360001
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Reclutamento
        • Investigational Site Number : 0360003
    • Western Australia
      • South Perth, Western Australia, Australia, 6151
        • Reclutamento
        • Investigational Site Number : 0360002
  • Belgio
      • Brussels, Belgio, 1070
        • Reclutamento
        • Investigational Site Number : 0560002
      • Ghent, Belgio, 9000
        • Reclutamento
        • Investigational Site Number : 0560001
      • Liège, Belgio, 4000
        • Reclutamento
        • Investigational Site Number : 0560004
  • Brasile
      • São Paulo, Brasile, 05651-901
        • Reclutamento
        • Hospital Israelita Albert Einstein- Site Number : 0760004
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasile, 41820-020
        • Reclutamento
        • Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
    • São Paulo
      • Campinas, São Paulo, Brasile, 13083-888
        • Reclutamento
        • Hospital das Clinicas da UNICAMP- Site Number : 0760002
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Reclutamento
        • Investigational Site Number : 1240016
    • Ontario
      • Mississauga, Ontario, Canada, L4W 0C2
        • Reclutamento
        • Investigational Site Number : 1240015
      • Richmond Hill, Ontario, Canada, L4B 1L1
        • Reclutamento
        • Investigational Site Number : 1240001
      • Toronto, Ontario, Canada, M2N 3A6
        • Reclutamento
        • Investigational Site Number : 1240014
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Reclutamento
        • Investigational Site Number : 1240010
      • Sherbrooke, Quebec, Canada, J1G 1X9
        • Reclutamento
        • Investigational Site Number : 1240002
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4V 1R9
        • Reclutamento
        • Investigational Site Number : 1240013
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Reclutamento
        • Investigational Site Number : 1240011
  • Cina
      • Beijing, Cina, 100730
        • Reclutamento
        • Investigational Site Number : 1560001
      • Changsha, Cina, 410011
        • Reclutamento
        • Investigational Site Number : 1560003
      • Hangzhou, Cina, 310009
        • Reclutamento
        • Investigational Site Number : 1560006
      • Shanghai, Cina, 200040
        • Reclutamento
        • Investigational Site Number : 1560004
      • Wuhan, Cina, 430022
        • Reclutamento
        • Investigational Site Number : 1560002
  • Francia
      • Lille, Francia, 59020
        • Reclutamento
        • Investigational Site Number : 2500005
      • Lille, Francia, 59037
        • Reclutamento
        • Investigational Site Number : 2500006
      • Nantes, Francia, 44093
        • Reclutamento
        • Investigational Site Number : 2500002
      • Paris, Francia, 75010
        • Reclutamento
        • Investigational Site Number : 2500004
      • Rouen, Francia, 76031
        • Reclutamento
        • Investigational Site Number : 2500003
  • Germania
      • Blankenfelde-Mahlow, Germania, 15831
        • Reclutamento
        • Investigational Site Number : 2760004
      • Darmstadt, Germania, 64283
        • Reclutamento
        • Investigational Site Number : 2760007
      • Dresden, Germania, 01307
        • Reclutamento
        • Investigational Site Number : 2760006
      • Merzig, Germania, 66663
        • Reclutamento
        • Investigational Site Number : 2760005
      • Regensburg, Germania, 93053
        • Reclutamento
        • Investigational Site Number : 2760003
      • Rostock, Germania, 18055
        • Reclutamento
        • Investigational Site Number : 2760002
  • Giappone
      • Tokyo, Giappone, 173-8610
        • Reclutamento
        • Investigational Site Number : 3920001
      • Tokyo, Giappone, 160-0023
        • Reclutamento
        • Investigational Site Number : 3920002
    • Aichi-ken
      • Nagoya, Aichi-ken, Giappone, 467-8602
        • Reclutamento
        • Investigational Site Number : 3920004
    • Ibaraki
      • Tsukuba, Ibaraki, Giappone, 305-8576
        • Reclutamento
        • Investigational Site Number : 3920005
    • Saitama
      • Koshigaya, Saitama, Giappone, 343-0845
        • Reclutamento
        • Investigational Site Number : 3920003
  • Italia
      • Brescia, Italia, 25123
        • Reclutamento
        • Investigational Site Number : 3800004
      • Chieti, Italia, 66100
        • Reclutamento
        • Investigational Site Number : 3800001
      • Pisa, Italia, 56126
        • Reclutamento
        • Investigational Site Number : 3800006
    • Ancona
      • Torette, Ancona, Italia, 60020
        • Reclutamento
        • Investigational Site Number : 3800002
    • Ferrara
      • Cona, Ferrara, Italia, 44124
        • Reclutamento
        • Investigational Site Number : 3800005
    • Milano
      • Garbagnate Milanese, Milano, Italia, 20024
        • Reclutamento
        • Investigational Site Number : 3800007
      • Milan, Milano, Italia, 20132
        • Reclutamento
        • Investigational Site Number : 3800003
  • Spagna
      • Córdoba, Spagna, 14004
        • Reclutamento
        • Investigational Site Number : 7240001
      • Málaga, Spagna, 29016
        • Reclutamento
        • Investigational Site Number : 7240004
    • Basque Country
      • Bilbao, Basque Country, Spagna, 48013
        • Reclutamento
        • Investigational Site Number : 7240002
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spagna, 08035
        • Reclutamento
        • Investigational Site Number : 7240006
    • Sevilla
      • Seville, Sevilla, Spagna, 41009
        • Reclutamento
        • Investigational Site Number : 7240005
  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85260
        • Reclutamento
        • Scottsdale Clinical Trials- Site Number : 8400006
    • California
      • North Hollywood, California, Stati Uniti, 91606
        • Attivo, non reclutante
        • Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
    • Florida
      • Boynton Beach, Florida, Stati Uniti, 33436
        • Reclutamento
        • Encore Medical Research of Boynton Beach- Site Number : 8400005
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Reclutamento
        • FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
      • Fort Myers, Florida, Stati Uniti, 33912
        • Reclutamento
        • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
      • Hollywood, Florida, Stati Uniti, 33024
        • Reclutamento
        • Encore Medical Research - Hollywood- Site Number : 8400004
      • Miami, Florida, Stati Uniti, 33173
        • Reclutamento
        • Florida International Research Center- Site Number : 8400002
      • Miami, Florida, Stati Uniti, 33146
        • Reclutamento
        • Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
      • Miami, Florida, Stati Uniti, 33174
        • Reclutamento
        • Florida Research Center- Site Number : 8400009
      • Tampa, Florida, Stati Uniti, 33607
        • Reclutamento
        • Advanced Clinical Research Institute- Site Number : 8400021
    • Georgia
      • Cumming, Georgia, Stati Uniti, 30040
        • Reclutamento
        • Cleaver Medical Group Dermatology- Site Number : 8400008
      • Fayetteville, Georgia, Stati Uniti, 30214
        • Reclutamento
        • First Georgia Physician Group- Site Number : 8400033
    • Illinois
      • Skokie, Illinois, Stati Uniti, 60077
        • Reclutamento
        • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019
    • Indiana
      • Evansville, Indiana, Stati Uniti, 47708
        • Reclutamento
        • Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40241
        • Reclutamento
        • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64108
        • Reclutamento
        • University Health Dermatology- Site Number : 8400018
    • New York
      • The Bronx, New York, Stati Uniti, 10455
        • Reclutamento
        • Equity Medical (LLC)- Site Number : 8400010
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74137
        • Reclutamento
        • Essential Medical Research- Site Number : 8400015
    • Texas
      • The Woodlands, Texas, Stati Uniti, 77380
        • Reclutamento
        • Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
    • Virginia
      • Norfolk, Virginia, Stati Uniti, 23502
        • Reclutamento
        • Virginia Dermatology & Skin Cancer Center- Site Number : 8400024
  • Svezia
      • Uppsala, Svezia, 752 37
        • Reclutamento
        • Investigational Site Number : 7520002
      • Örebro, Svezia, 701 85
        • Reclutamento
        • Investigational Site Number : 7520001
  • Turchia (Türkiye)
      • Buca, Turchia (Türkiye), 35390
        • Reclutamento
        • Investigational Site Number : 7920006
      • Istanbul, Turchia (Türkiye), 34093
        • Reclutamento
        • Investigational Site Number : 7920001
      • Istanbul, Turchia (Türkiye), 34899
        • Reclutamento
        • Investigational Site Number : 7920005
      • Izmir, Turchia (Türkiye), 35540
        • Reclutamento
        • Investigational Site Number : 7920004
      • Manisa, Turchia (Türkiye), 45030
        • Reclutamento
        • Investigational Site Number : 7920002
      • Samsun, Turchia (Türkiye), 55139
        • Reclutamento
        • Investigational Site Number : 7920003
  • Ungheria
      • Budapest, Ungheria, 1085
        • Reclutamento
        • Investigational Site Number : 3480002
      • Gyula, Ungheria, 5700
        • Reclutamento
        • Investigational Site Number : 3480005
      • Kaposvár, Ungheria, 7400
        • Reclutamento
        • Investigational Site Number : 3480003
      • Szeged, Ungheria, 6720
        • Reclutamento
        • Investigational Site Number : 3480004

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SAR445399 dose regimen A

Participants will receive SAR445399 dose regimen A.
Droga: SAR445399

Pharmaceutical form: Solution for injection -Route of administration: Injection
Sperimentale: SAR445399 dose regimen B

Participants will receive SAR445399 dose regimen B.
Droga: SAR445399

Pharmaceutical form: Solution for injection -Route of administration: Injection
Comparatore placebo: Placebo

Participants will receive SAR445399-matching placebo.
Droga: Placebo

Pharmaceutical form: Solution for injection -Route of administration: Injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Variazione percentuale dal basale alla Settimana 16 nel conteggio dei tunnel drenanti
Lasso di tempo: Dal basale alla settimana 16
Dal basale alla settimana 16
Variazione assoluta rispetto al basale alla Settimana 16 nel conteggio dei tunnel drenanti
Lasso di tempo: Dal basale alla settimana 16
Dal basale alla settimana 16
Variazione percentuale dal basale alla Settimana 16 nella Scala di Valutazione Numerica del Dolore Cutaneo dell'Idrosadenite Suppurativa (HS-Skin Pain NRS)
Lasso di tempo: Dal Basale alla Settimana 16
Dal Basale alla Settimana 16
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
Lasso di tempo: Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Plasma concentrations of SAR445399 during the double-blinded initial treatment period and the treatment-blinded extension period
Lasso di tempo: Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints during the double-blinded initial treatment period and the treatment-blinded extension period
Lasso di tempo: Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Lasso di tempo: 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
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
Lasso di tempo: 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
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 dicembre 2025

Completamento primario (Stimato)

22 settembre 2027

Completamento dello studio (Stimato)

19 novembre 2027

Date di iscrizione allo studio

Primo inviato

4 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

4 novembre 2025

Primo Inserito (Effettivo)

6 novembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DRI20674
  • 2025-522695-83-00 (Identificatore di registro: CTIS)
  • U1111-1322-6148 (Altro identificatore: WHO-ICTRP)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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