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

Prior treatment

• 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.
• 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.

Other illness

• Crohn's Disease (CD) participants only:
  • --Participant with a current diagnosis of UC or indeterminate colitis.
• Participant diagnosed with short bowel syndrome.

Other

• Participant with ostomy or ileoanal pouch.
• 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.

• 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:
  • 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.
  • 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.