Microscopic ColitisPhase 2NCT07156175
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
A Phase 2 study testing SAR444336 in people with Microscopic Colitis, run by Sanofi at 24 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microscopic Colitis
- What is being tested?
- SAR444336
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 24 sitesin 9 countries
- Study dates
- 14 Oct 2025to 6 May 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents.
- At screening, have abnormal laboratory values or ECG abnormalities.
- Participants with recent tuberculosis (TB) vaccination or positive TB test results.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
24 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
24 sites in 9 countries
Germany4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 2760001
Frankfurt, 60389
- Recruiting
Investigational Site Number : 2760005
Ludwigshafen, 67067
- Recruiting
Investigational Site Number : 2760003
Tübingen, 72076
- Recruiting
Investigational Site Number : 2760004
Ulm, 89081
Italy4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 3800004
Milan, Milano, 20122
- Recruiting
Investigational Site Number : 3800001
Padua, Padova, 35128
- Recruiting
Investigational Site Number : 3800003
Rome, Roma, 00168
- Recruiting
Investigational Site Number : 3800002
Turin, Torino, 10126
France3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 2500001
Créteil, 94010
- Recruiting
Investigational Site Number : 2500002
Montfermeil, 93370
- Recruiting
Investigational Site Number : 2500003
Pessac, 33604
Poland3 sites, 2 recruiting
- Completed
Investigational Site Number : 6160004
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-229
- Recruiting
Investigational Site Number : 6160003
Warsaw, Masovian Voivodeship, 00-728
- Recruiting
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, 02-507
Sweden3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7520001
Linköping, 581 85
- Recruiting
Investigational Site Number : 7520002
Stockholm, 113 61
- Recruiting
Investigational Site Number : 7520003
Stockholm, 116 91
Denmark2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2080003
Aarhus, 8200
- Recruiting
Investigational Site Number : 2080002
Hvidovre, 2650
Hungary2 sites, 1 recruiting
- Recruiting
Investigational Site Number : 3480002
Budapest, 1085
- Completed
Investigational Site Number : 3480003
Székesfehérvár, 8000
United Kingdom2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 8260002
Cambridge, Cambridgeshire, CB2 2QQ
- Recruiting
Investigational Site Number : 8260001
Oxford, Oxfordshire, OX3 9DU
Belgium1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0560001
Leuven, 3000
About this study
Official title: 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
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
- Being tested
- SAR444336, Placebo
- Medical subject headings
- Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR444336Drug
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
PlaceboDrug
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR444336 | Experimental | Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician. Receives: Drug: SAR444336 |
| Placebo | Placebo comparator | Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with sustained steroid-free clinical remission
Clinical remission defined as no relapse during the 24-week period.
Measured: 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)
Measured: up to week 28
Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)
Measured: up to week 28
Plasma concentrations of SAR444336
Measured: through week 24
Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336
Measured: through week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start14 Oct 2025
- Primary completion8 Apr 2027 (estimated)
- Study completion6 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156175
- Sponsor's protocol ID
- ACT18053
- Other IDs
- 2024-519495-83, U1111-1314-5201
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07156175
- Acronym / sponsor ID
- ACT18053
- Conditions
- Microscopic Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 8 Apr 2027 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR444336 | Experimental | Drug: SAR444336Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician. |
| Placebo | Placebo comparator | Drug: PlaceboEach participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR444336Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous | Drug | SAR444336 |
| PlaceboPharmaceutical form:Solution for injection -Route of administration:Subcutaneous | Drug | Placebo |
Primary outcome
Proportion of participants with sustained steroid-free clinical remission
Time frame: up to week 24
Clinical remission defined as no relapse during the 24-week period.
4 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: up to week 28
Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)
Time frame: up to week 28
Plasma concentrations of SAR444336
Time frame: through week 24
Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336
Time frame: through week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- ACT18053 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR444336 in people with Microscopic Colitis, run by Sanofi at 24 sites in 9 countries.
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 6 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Italy, France, Poland, Sweden and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of participants with sustained steroid-free clinical remission (time frame: up to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.