AzTrials
AzTrials

Ulcerative ColitisPhase 1NCT07923383

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

A Phase 1 study testing Duvakitug in people with Ulcerative Colitis and Crohn's Disease, run by Sanofi.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ulcerative Colitis, Crohn's Disease
What is being tested?
Duvakitug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
3 Nov 2026to 29 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

Contact-US@sanofi.com

About this study

Official title: 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.

Being tested
Duvakitug
Keywords
Colitis ulcerative
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuvakitugDrug

    Also called SAR447189

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

Study groups in NCT07923383
Study groupRoleWhat they receive
DuvakitugExperimentalSubcutaneous injection of duvakitug as per protocol and oral administration of caffeine, metoprolol, midazolam, omeprazole, warfarin and vitamin K as per protocol
Receives: Drug: Duvakitug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol

    AUC: Area under the plasma concentration versus time curve extrapolated to infinity

    Measured: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

  2. 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

    Measured: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

Secondary outcomes (7)

  1. Duvakitug serum concentrations: Ctrough

    Ctrough: Serum concentration observed just before treatment administration during multiple dosing

    Measured: At Treatment Period 2, from Day 1 to Day 85

  2. tmax of CYP substrates alone and after duvakitug administration

    tmax: Time to reach Cmax

    Measured: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

  3. 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.

    Measured: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

  4. tlast of CYP substrates alone and after duvakitug administration

    tlast: Time corresponding to the last concentration above the limit of quantification, Clast

    Measured: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

  5. Cmax of CYP substrates alone and after duvakitug administration

    Cmax: Maximum plasma concentration observed

    Measured: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)

  6. Number of participants with anti-drug antibodies against duvakitug

    Measured: At Treatment Period 2, from Day 1 to Day 85

  7. 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

    Measured: From Treatment Period 1, Day 1 until the End of Study visit (approximately 130 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start3 Nov 2026 (estimated)
  3. Primary completion8 Aug 2028 (estimated)
  4. Study completion29 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923383
Sponsor's protocol ID
INT20164
Other IDs
2026-525939-17, U1111-1332-7822
Status last verified
Nov 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Duvakitug in people with Ulcerative Colitis and Crohn's Disease, run by Sanofi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol (time frame: At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07923383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in