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En fase IIb dosejusteringsstudie for å vurdere effekt og sikkerhet av GIA632 hos deltakere med ikke-segmentert vitiligo (VITESS)

6. november 2026 oppdatert av: Novartis Pharmaceuticals

Et multicentrisk, randomisert, dobbeltblindt, placebokontrollert, dosebestemmende fase IIb-studie for å vurdere effektiviteten og sikkerheten til GIA632 hos voksne deltakere med ikke-segmentell vitiligo, etterfulgt av en forlengelsesperiode

The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This trial in adult participants ≥ 18 years with non-segmental vitiligo (NSV) consists of a randomized, double-blind, placebo-controlled period to establish and characterize the dose-response relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.

Studietype

Intervensjonell

Registrering (Antatt)

210

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Argentina
      • Caba, Argentina, C1015ABO
        • Rekruttering
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Rekruttering
        • Novartis Investigative Site
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1425DKG
        • Rekruttering
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1056ABI
        • Rekruttering
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1119ACN
        • Rekruttering
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DBS
        • Rekruttering
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Rekruttering
        • Novartis Investigative Site
      • Waitara, New South Wales, Australia, 2077
        • Rekruttering
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Rekruttering
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Rekruttering
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Rekruttering
        • Novartis Investigative Site
    • Ontario
      • Mississauga, Ontario, Canada, L4Y 4C5
        • Rekruttering
        • Novartis Investigative Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Rekruttering
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M3H 5Y8
        • Rekruttering
        • Novartis Investigative Site
    • Quebec
      • Québec, Quebec, Canada, G2G 2R1
        • Rekruttering
        • Novartis Investigative Site
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35244
        • Rekruttering
        • Cahaba Derm and skin hlth ctr 27
        • Hovedetterforsker:
          • Vlada Groysman
        • Ta kontakt med:
    • California
      • Fountain Valley, California, Forente stater, 92708
        • Rekruttering
        • First OC Dermatology
        • Hovedetterforsker:
          • Vivian Laquer
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92103
        • Rekruttering
        • MedDerm Associates
        • Hovedetterforsker:
          • Michelle Pelle
        • Ta kontakt med:
      • Thousand Oaks, California, Forente stater, 91320
        • Rekruttering
        • Clinical Trials Research Institute
        • Hovedetterforsker:
          • Navid Ezra
        • Ta kontakt med:
    • Florida
      • Hollywood, Florida, Forente stater, 33024
        • Rekruttering
        • Encore Medical Research
        • Hovedetterforsker:
          • Jerome Obed
        • Ta kontakt med:
      • Jacksonville, Florida, Forente stater, 32224
        • Rekruttering
        • Mayo Clinic Jacksonville
        • Hovedetterforsker:
          • Ashley Wentworth
        • Ta kontakt med:
      • Miami, Florida, Forente stater, 33173
        • Rekruttering
        • Miami Derm and Laser Institute
        • Hovedetterforsker:
          • Jill Waibel
        • Ta kontakt med:
      • St. Petersburg, Florida, Forente stater, 33714
        • Rekruttering
        • Global Clinical Professionals
        • Hovedetterforsker:
          • Wanda M Boote
        • Ta kontakt med:
    • Illinois
      • Glenview, Illinois, Forente stater, 60077
        • Rekruttering
        • Endeavor Health
        • Hovedetterforsker:
          • Shannon Ewing
        • Ta kontakt med:
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46256
        • Rekruttering
        • Dawes Fretzin Clinical Rea Group
        • Hovedetterforsker:
          • Kenneth Dawes
        • Ta kontakt med:
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • Rekruttering
        • DermAssociates LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Benjamin N Lockshin
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Rekruttering
        • Uni Of Michigan Health System
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael T Goldfarb
      • Fort Gratiot, Michigan, Forente stater, 48059
        • Rekruttering
        • Hamzavi Dermatology
        • Hovedetterforsker:
          • Iltefat Hamzavi
        • Ta kontakt med:
      • Troy, Michigan, Forente stater, 48084
        • Rekruttering
        • Revival Research Institute
        • Hovedetterforsker:
          • Ali Moiin
        • Ta kontakt med:
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68144
        • Rekruttering
        • Skin Specialists PC
        • Hovedetterforsker:
          • Joel Schlessinger
        • Ta kontakt med:
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89144
        • Rekruttering
        • Las Vegas Dermatology
        • Ta kontakt med:
        • Hovedetterforsker:
          • Harry Lawrence Greenberg
    • New York
      • The Bronx, New York, Forente stater, 10455
        • Rekruttering
        • Equity Medical
        • Hovedetterforsker:
          • Michael Cameron
        • Ta kontakt med:
    • Oregon
      • Portland, Oregon, Forente stater, 97223
        • Rekruttering
        • Oregon Medical Research Center
        • Hovedetterforsker:
          • Benjamin D Ehst
        • Ta kontakt med:
    • Tennessee
      • Murfreesboro, Tennessee, Forente stater, 37130
        • Rekruttering
        • International Clinical Research Tennessee LCC
        • Hovedetterforsker:
          • Christina Feser
        • Ta kontakt med:
    • Texas
      • Bellaire, Texas, Forente stater, 77401
        • Rekruttering
        • Bellaire Dermatology Associates
        • Hovedetterforsker:
          • Craig F Teller
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Center for Clinical Studies
        • Hovedetterforsker:
          • Stephen K Tyring
        • Ta kontakt med:
      • Pflugerville, Texas, Forente stater, 78660
        • Rekruttering
        • Austin Inst for Clinical Research
        • Hovedetterforsker:
          • Edward Lain
        • Ta kontakt med:
      • Plano, Texas, Forente stater, 75024
        • Rekruttering
        • ACRC Trials
        • Ta kontakt med:
        • Hovedetterforsker:
          • Seemal Rohit Desai
    • Virginia
      • Norfolk, Virginia, Forente stater, 23507
        • Rekruttering
        • Virginia Clinical Research
        • Hovedetterforsker:
          • David M Pariser
        • Ta kontakt med:
  • Frankrike
      • Bordeaux, Frankrike, 33075
        • Rekruttering
        • Novartis Investigative Site
      • Brest, Frankrike, 29609
        • Rekruttering
        • Novartis Investigative Site
      • Créteil, Frankrike, 94010
        • Rekruttering
        • Novartis Investigative Site
      • Nice, Frankrike, 06202
        • Rekruttering
        • Novartis Investigative Site
      • Reims, Frankrike, 51100
        • Rekruttering
        • Novartis Investigative Site
      • Rouen, Frankrike, 76031
        • Rekruttering
        • Novartis Investigative Site
      • Toulouse, Frankrike, 31400
        • Rekruttering
        • Novartis Investigative Site
  • India
    • Bihar
      • Patna, Bihar, India, 801507
        • Rekruttering
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • Rekruttering
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560074
        • Rekruttering
        • Novartis Investigative Site
      • Belagavi, Karnataka, India, 590010
        • Rekruttering
        • Novartis Investigative Site
      • Mysore, Karnataka, India, 570001
        • Rekruttering
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, India, 422101
        • Rekruttering
        • Novartis Investigative Site
  • Italia
    • AN
      • Ancona, AN, Italia, 60020
        • Rekruttering
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italia, 44124
        • Rekruttering
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italia, 20122
        • Rekruttering
        • Novartis Investigative Site
      • Rozzano, MI, Italia, 20089
        • Rekruttering
        • Novartis Investigative Site
  • Japan
      • Niigata, Japan, 9518520
        • Rekruttering
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4678602
        • Rekruttering
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 4578510
        • Rekruttering
        • Novartis Investigative Site
    • Chiba
      • Urayasu, Chiba, Japan, 2790021
        • Rekruttering
        • Novartis Investigative Site
    • Tokyo
      • Shinjuku Ku, Tokyo, Japan, 1600023
        • Rekruttering
        • Novartis Investigative Site
    • Yamanashi
      • Kofu, Yamanashi, Japan, 4008506
        • Rekruttering
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100050
        • Rekruttering
        • Novartis Investigative Site
      • Shanghai, Kina, 200040
        • Rekruttering
        • Novartis Investigative Site
      • Tianjin, Kina, 300052
        • Rekruttering
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510091
        • Rekruttering
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Novartis Investigative Site
  • Nederland
    • North Holland
      • Amsterdam, North Holland, Nederland, 1105 AZ
        • Rekruttering
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Nederland, 3015 GD
        • Rekruttering
        • Novartis Investigative Site
  • Spania
      • Barcelona, Spania, 08041
        • Rekruttering
        • Novartis Investigative Site
      • Córdoba, Spania, 14004
        • Rekruttering
        • Novartis Investigative Site
      • Granada, Spania, 18016
        • Rekruttering
        • Novartis Investigative Site
      • Madrid, Spania, 28041
        • Rekruttering
        • Novartis Investigative Site
      • Madrid, Spania, 28006
        • Rekruttering
        • Novartis Investigative Site
      • Pontevedra, Spania, 36003
        • Rekruttering
        • Novartis Investigative Site
      • Seville, Spania, 41009
        • Rekruttering
        • Novartis Investigative Site
    • A Coruna
      • Santiago de Compostela, A Coruna, Spania, 15706
        • Rekruttering
        • Novartis Investigative Site
  • Tyskland
      • Bad Bentheim, Tyskland, 48455
        • Rekruttering
        • Novartis Investigative Site
      • Bielefeld, Tyskland, 33647
        • Rekruttering
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20354
        • Rekruttering
        • Novartis Investigative Site
      • Hanover, Tyskland, 30625
        • Rekruttering
        • Novartis Investigative Site
      • Lübeck, Tyskland, 23538
        • Rekruttering
        • Novartis Investigative Site
      • Münster, Tyskland, 48149
        • Rekruttering
        • Novartis Investigative Site
      • Tübingen, Tyskland, 72076
        • Rekruttering
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Tyskland, 81377
        • Rekruttering
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study
  • Male or female as assigned at birth ≥ 18 years of age at the time of screening
  • Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator
  • Non-segmental vitiligo, as assessed at screening, as
  • ≥ 0.5% Body Surface Area (BSA) on the face and F-VASI score ≥ 0.5
  • ≥ 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60

Exclusion Criteria:

  • Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires
  • Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations [such as piebaldism, Waardenburg, etc.], chemical- or druginduced leukoderma, etc.)
  • Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors
  • Individual who previously attempted or completed depigmentation therapy for NSV
  • Use of prohibited medication & treatments. Other protocol-defined inclusion/exclusion criteria may apply

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: GIA632 Arm 1

GIA632 will be administered during the 48-week core period.
Legemiddel: GIA632

GIA632 will be administered during the 48-week core period.
Eksperimentell: GIA632 Arm 2

GIA632 will be administered during the 48-week core period.
Legemiddel: GIA632

GIA632 will be administered during the 48-week core period.
Eksperimentell: GIA632 Arm 3

GIA632 will be administered during the 48-week core period.
Legemiddel: GIA632

GIA632 will be administered during the 48-week core period.
Eksperimentell: GIA632 Arm 4

GIA632 will be administered during the 48-week core period.
Legemiddel: GIA632

GIA632 will be administered during the 48-week core period.
Placebo komparator: Placebo

Placebo will be administered during the 48-week core period.
Legemiddel: Placebo

Placebo will be administered during the 48-week core period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
Tidsramme: Baseline, Week 24

The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.
Baseline, Week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)
Tidsramme: Baseline, Week 24

The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.
Baseline, Week 24
Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.
Tidsramme: Baseline, Week 24

T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body.
Baseline, Week 24
Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)
Tidsramme: Baseline, Week 24

T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body.
Baseline, Week 24
Achievement of F-VASI50, F-VASI75, and FVASI90
Tidsramme: Baseline, Week 12, Week 24, Week 36, and Week 48

The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. F-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the facial vitiligo area scoring index (F-VASI), respectively.
Baseline, Week 12, Week 24, Week 36, and Week 48
Achievement of T-VASI50, T-VASI75, and TVASI90
Tidsramme: Baseline, Week 12, Week 24, Week 36, and Week 48.

T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. T-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the total vitiligo area scoring index (T-VASI), respectively.
Baseline, Week 12, Week 24, Week 36, and Week 48.
Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5
Tidsramme: Week 12, Week 24, Week 36, and at Week 48.

The VNS is a patient-reported outcome (PRO) measure of treatment response, which has been shown to have face validity. This involved an online survey, to identify which aspects of treatment response are most important to participants. A scale with five response options (both words and numbers) is the best available scale to use when assessing treatment response (whereas giving a binary 'yes'/'no' response was more difficult); and a score of 4 or 5 on the scale represents a successful treatment response.
Week 12, Week 24, Week 36, and at Week 48.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. mars 2026

Primær fullføring (Antatt)

6. juni 2028

Studiet fullført (Antatt)

28. januar 2030

Datoer for studieregistrering

Først innsendt

18. februar 2026

Først innsendt som oppfylte QC-kriteriene

18. februar 2026

Først lagt ut (Faktiske)

24. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CGIA632B12201
  • 2025-522301-37-00 (Annen identifikator: EU CTIS)
  • 2025 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere