A Phase 1 interventional study of Duvakitug in Ulcerative Colitis and Crohn's Disease, sponsored by Sanofi. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Sanofi · Phase 1, Interventional, and Basic science
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 25 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ulcerative colitis (UC) participants only:
Crohn's Disease (CD) participants only:
Participants with moderately to severely active CD, defined as:
Conventional therapies
S1PRm (eg, ozanimod, etrasimod).
Exclusion Criteria:
For ulcerative colitis (UC) participants only:
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:
Any to one or more of the following CYP cocktail study interventions, according to the applicable labeling:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous injection of duvakitug as per protocol and oral administration of caffeine, metoprolol, midazolam, omeprazole, warfarin and vitamin K as per protocol
Drug: Duvakitug
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Also known as: SAR447189
AUC for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol
AUC: Area under the plasma concentration versus time curve extrapolated to infinity
Time frame: 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
AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Time frame: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)
Duvakitug serum concentrations: Ctrough
Ctrough: Serum concentration observed just before treatment administration during multiple dosing
Time frame: At Treatment Period 2, from Day 1 to Day 85
tmax of CYP substrates alone and after duvakitug administration
tmax: Time to reach Cmax
Time frame: 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
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.
Time frame: 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
tlast: Time corresponding to the last concentration above the limit of quantification, Clast
Time frame: 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
Cmax: Maximum plasma concentration observed
Time frame: 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
Time frame: 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
TEAE: treatment-emergent adverse event, TESAE: treatment-emergent serious adverse event, TEAESI: treatment-emergent adverse event of special interest
Time frame: From Treatment Period 1, Day 1 until the End of Study visit (approximately 130 days)
No study locations are listed for this record.
Plan to share: Yes — 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Duvakitug