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A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521035-37-00
Enrollment
210
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune system diseases

Brief summary

Proportion of participants achieving clinical remission.

Detailed description

Proportion of participants who achieve endoscopic improvement., Proportion of participants achieving clinical response by modified Mayo Score (mMS)., Proportion of participants achieving histological endoscopic mucosal improvement., Change from baseline in PROMIS-Fatigue Short Form 7a T-score., Proportion of participants with symptomatic (SFS and RBS) remission, Proportion of participants with no bowel urgency, Proportion of participants reporting no nocturnal bowel movements, Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission., Proportion of participants who achieve endoscopic remission., Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS)., Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score., Proportion of participants with UC-related hospitalization, Proportion of participants achieving clinical remission and no steroid use., Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment- Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation., Serum concentration of duvakitug measured over time., Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants achieving clinical remission.

Secondary

MeasureTime frame
Proportion of participants who achieve endoscopic improvement., Proportion of participants achieving clinical response by modified Mayo Score (mMS)., Proportion of participants achieving histological endoscopic mucosal improvement., Change from baseline in PROMIS-Fatigue Short Form 7a T-score., Proportion of participants with symptomatic (SFS and RBS) remission, Proportion of participants with no bowel urgency, Proportion of participants reporting no nocturnal bowel movements, Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission., Proportion of participants who achieve endoscopic remission., Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS)., Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score., Proportion of participants with UC-related hospitalization, Proportion of participants achieving clinical remission and no steroid use., Incidence of Treat

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 11, 2026