A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519495-83-00

Acronym

ACT18053

Enrollment

Registered

2025-09-29

Start date

2025-10-28

Completion date

Unknown

Last updated

2025-11-07

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

Conditions

Digestive system diseases

Brief summary

Proportion of participants with sustained steroid-free clinical remission.

Detailed description

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)., Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)., Plasma concentrations of SAR444336, Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336

Interventions

DRUGMatched placebo for test product

DRUGSAR444336

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants with sustained steroid-free clinical remission.	—

Secondary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)., Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)., Plasma concentrations of SAR444336, Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336	—

Measure

Time frame

—

Countries

Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026