A study to investigate the efficacy and safety of SAR444336 in adults with microscopic colitis in clinical remission.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2025-09-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sanofi-Aventis Recherche et Développement

External identifiers

EU CT number

2024-519495-83-00

WHO UTN

U1111-1314-5201

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Therapy, Safety, Efficacy

Evaluate the efficacy of SAR444336 as steroid-free therapy in participants with microscopic
colitis as compared to placebo

Secondary objectives 3

1. Evaluate the safety and tolerability of SAR444336
2. Evaluate the pharmacokinetics of SAR444336
3. Evaluate immunogenicity in participants treated with SAR444336

Conditions and MedDRA coding

Digestive system diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 18

1. Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.
2. Evidence of infectious diarrhea in the 3 months prior to randomization.
3. Other active diarrheal conditions or suspicion of drug-induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome.
4. Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization.
5. Previous bowel surgeries.
6. Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed.
7. Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment.
8. Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months.
9. History or presence of alcohol or illicit drug abuse within the past 2 years.
10. Excessive consumption of beverages containing xanthine bases.
11. History of solid organ transplant.
12. 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.
13. 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.
14. 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.
15. Live attenuated vaccines within 6 weeks of randomization and during the study.
16. Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents.
17. At screening, have abnormal laboratory values or ECG abnormalities.
18. Participants with recent tuberculosis (TB) vaccination or positive TB test results.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with sustained steroid-free clinical remission.

Secondary endpoints 4

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 15

Locations

8 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 90 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications