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

Ki vehet részt

• 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

Ki nem vehet részt

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