A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission

NCT07156175 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: ACT180532024-519495-83U1111-1314-5201
• Study Type: interventional
• Target: 54
• Locations: 9 countries
• Sites: 26

Brief Summary

This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.

Conditions

Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with sustained steroid-free clinical remission

  Clinical remission defined as no relapse during the 24-week period.

  up to week 24

Secondary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

  up to week 28

• Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)

  up to week 28

• Plasma concentrations of SAR444336

  through week 24

• Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336

  through week 24

Study Arms (2)

SAR444336

EXPERIMENTAL

Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.

Drug: SAR444336

Placebo

PLACEBO COMPARATOR

Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

SAR444336 DRUG

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

SAR444336

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).
• Receiving budesonide therapy.
• Documented clinical remission from 2 weeks before screening.
• At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.
• Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit.
• All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.

You may not qualify if:

• Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.
• Evidence of infectious diarrhea in the 3 months prior to randomization.
• Other active diarrheal conditions or suspicion of drug--induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome.
• Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization.
• Previous bowel surgeries.
• Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed.
• Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment.
• Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months.
• History or presence of alcohol or illicit drug abuse within the past 2 years.
• Excessive consumption of beverages containing xanthine bases.
• History of solid organ transplant.
• Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
• Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure.
• Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic.
• Live attenuated vaccines within 6 weeks of randomization and during the study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (26)

Investigational Site Number : 0560002

Ghent, 9000, Belgium

RECRUITING

Investigational Site Number : 0560001

Leuven, 3000, Belgium

RECRUITING

Investigational Site Number : 2080003

Aarhus, 8200, Denmark

RECRUITING

Investigational Site Number : 2080002

Hvidovre, 2650, Denmark

RECRUITING

Investigational Site Number : 2500001

Créteil, 94010, France

RECRUITING

Investigational Site Number : 2500002

Montfermeil, 93370, France

RECRUITING

Investigational Site Number : 2500003

Pessac, 33604, France

RECRUITING

Investigational Site Number : 2760001

Frankfurt, 60389, Germany

RECRUITING

Investigational Site Number : 2760005

Ludwigshafen, 67067, Germany

RECRUITING

Investigational Site Number : 2760002

Potsdam, 14467, Germany

RECRUITING

Investigational Site Number : 2760003

Tübingen, 72076, Germany

RECRUITING

Investigational Site Number : 2760004

Ulm, 89081, Germany

RECRUITING

Investigational Site Number : 3480002

Budapest, 1085, Hungary

RECRUITING

Investigational Site Number : 3480003

Székesfehérvár, 8000, Hungary

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004

Milan, Milano, 20122, Italy

RECRUITING

Azienda Ospedale Università Padova, Investigational Site Number : 380001

Padua, Padova, 35128, Italy

RECRUITING

Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003

Rome, Roma, 00168, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002

Turin, Torino, 10126, Italy

RECRUITING

Investigational Site Number : 6160004

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-229, Poland

RECRUITING

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, 00-728, Poland

RECRUITING

Investigational Site Number : 6160002

Warsaw, Masovian Voivodeship, 02-507, Poland

RECRUITING

Investigational Site Number : 7520001

Linköping, 581 85, Sweden

RECRUITING

Investigational Site Number : 7520002

Stockholm, 113 61, Sweden

RECRUITING

Investigational Site Number : 7520003

Stockholm, 116 91, Sweden

RECRUITING

Investigational Site Number : 8260002

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

Investigational Site Number : 8260001

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Related Links

• ACT18053 Plain Language Results Summary

MeSH Terms

Conditions

Colitis, Microscopic

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

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

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 5, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): May 6, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

HU (2); DE (5); IT (4); PL (3); BE (2); DK (2); FR (3); SE (3); GB (2)