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An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates

2. november 2026 oppdatert av: Sanofi

An Open-label, Single-sequence Drug-drug Interaction Study to Investigate the Effects of Duvakitug on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

This is an open-label, single group, 2-period, Phase 1, single-arm study. The primary purpose of this study is to investigate the effects of duvakitug on the pharmacokinetics of selected cytochrome P450 substrates in adult participants with moderately to severely active ulcerative colitis or Crohn's disease. Approximately 25 participants will be enrolled. The total study duration per participant will be approximately 166 days.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

25

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-post: Contact-US@sanofi.com

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 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants aged ≥18 and ≤65 years (both inclusive) of age at Screening.

  • Ulcerative colitis (UC) participants only:

    • Confirmed diagnosis of UC for at least 3 months prior to Screening.
    • Active UC with a modified Mayo Score of 5 to 9 points and Mayo Endoscopic Subscore of 2 to 3 at Screening (historical endoscopy within 3 months of screening). If no data are available or if available historical endoscopy data are deemed insufficient to determine clinical status, an endoscopy will be performed at Screening.

  • Crohn's Disease (CD) participants only:

    • Confirmed diagnosis of CD for at least 3 months prior to Screening.

    • Participants with moderately to severely active CD, defined as:

      1. Persistently active disease with a Crohn's Disease Activity Index score of 220 to 450, with endoscopic Simple Endoscopic Score for Crohn's Disease score (excluding the presence of narrowing component) ≥6 (or ≥4 for participants with isolated ileal disease), (historical endoscopy within 3 months of Screening). If no data are available, an endoscopy will be performed at Screening.
      2. Average daily very soft or liquid stool frequency ≥4.0 and/or average daily abdominal pain score ≥2.0 at Screening.

  • Demonstrated inadequate response, loss of response or intolerance to conventional therapies or advanced therapies, in the opinion of the Investigator to at least 1 of following approved treatments:

Conventional therapies

  • Immunomodulators (eg, AZA, 6-MP, MTX, tacrolimus, thioguanine).

  • IV or oral corticosteroids. Advanced therapies

  • Biologics (eg, infliximab, golimumab, adalimumab, certolizumab pegol, natalizumab, vedolizumab, risankizumab, guselkumab, mirikizumab, ustekinumab)

  • JAKi (eg, upadacitinib).

  • S1PRm (eg, ozanimod, etrasimod).

    • Participant must weigh >40 kg.

Exclusion Criteria:

  • For ulcerative colitis (UC) participants only:

    • Participant with a current diagnosis of CD or indeterminate colitis.
    • Participant with a current diagnosis of ulcerative proctitis (disease limited to the rectum) during the screening endoscopy and in the available endoscopic report.
    • Participant with surgical bowel resection within the past 3 months prior to Screening, or a history of >3 bowel resections.

  • Crohn's Disease (CD) participants only:

    --Participant with a current diagnosis of UC or indeterminate colitis.

  • Participant with the following current complications of UC or CD:

    • Abscess (abdominal or peri-anal),
    • Impassable or symptomatic bowel strictures,
    • Fulminant colitis, or toxic megacolon, or
    • Any other manifestation that might require surgery while enrolled in the study.

  • Participant with ostomy or ileoanal pouch.

  • Participant diagnosed with short bowel syndrome.

  • Poor metabolizers for cytochrome P450 (CYP) 2C9, CYP2C19, or CYP2D6 based on genotyping. Participants who do not consent to this required CYP genotype testing will be excluded from the study.

  • Any contraindication to one or more of the following CYP cocktail study interventions, according to the applicable labeling:

    • Caffeine.
    • Metoprolol.
    • Midazolam.
    • Omeprazole.
    • Warfarin.
    • Vitamin K.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Duvakitug

Subcutaneous injection of duvakitug as per protocol and oral administration of caffeine, metoprolol, midazolam, omeprazole, warfarin and vitamin K as per protocol
Legemiddel: Duvakitug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Andre navn:
  • SAR447189

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AUC for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol
Tidsramme: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

AUC: Area under the plasma concentration versus time curve extrapolated to infinity
At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)
AUClast for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol
Tidsramme: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duvakitug serum concentrations: Ctrough
Tidsramme: At Treatment Period 2, from Day 1 to Day 85

Ctrough: Serum concentration observed just before treatment administration during multiple dosing
At Treatment Period 2, from Day 1 to Day 85
tmax of CYP substrates alone and after duvakitug administration
Tidsramme: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

tmax: Time to reach Cmax
At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)
t1/2 of CYP substrates alone and after duvakitug administration
Tidsramme: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

Terminal half-life associated with the terminal slope (λz) where λz is the slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi logarithmic scale. Half-life is calculated by taking the regression of at least 3 points.
At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)
tlast of CYP substrates alone and after duvakitug administration
Tidsramme: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

tlast: Time corresponding to the last concentration above the limit of quantification, Clast
At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)
Cmax of CYP substrates alone and after duvakitug administration
Tidsramme: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

Cmax: Maximum plasma concentration observed
At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)
Number of participants with anti-drug antibodies against duvakitug
Tidsramme: At Treatment Period 2, from Day 1 to Day 85
At Treatment Period 2, from Day 1 to Day 85
Number of participants with TEAEs, TESAEs, TEAESIs, and TEAEs leading to permanent study intervention discontinuation
Tidsramme: From Treatment Period 1, Day 1 until the End of Study visit (approximately 130 days)

TEAE: treatment-emergent adverse event, TESAE: treatment-emergent serious adverse event, TEAESI: treatment-emergent adverse event of special interest
From Treatment Period 1, Day 1 until the End of Study visit (approximately 130 days)

Samarbeidspartnere og etterforskere

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

Sponsor

Sanofi

Samarbeidspartnere

Teva Branded Pharmaceutical Products R&D LLC

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 (Antatt)

3. november 2026

Primær fullføring (Antatt)

8. august 2028

Studiet fullført (Antatt)

29. august 2028

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • INT20164
  • 2026-525939-17 (Registeridentifikator: CTIS (EU))
  • U1111-1332-7822 (Registeridentifikator: ICTRP)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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