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

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

Overview

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.

Interventions

• Drug SAR444336
  Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
• Drug Placebo
  Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous

Primary outcome measures

• Proportion of participants with sustained steroid-free clinical remission [Time frame: up to week 24]

Secondary outcome measures (4)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Germany · 5 centers

• Investigational Site Number : 2760001 — Frankfurt
• Investigational Site Number : 2760005 — Ludwigshafen
• Investigational Site Number : 2760002 — Potsdam
• Investigational Site Number : 2760003 — Tübingen
• Investigational Site Number : 2760004 — Ulm

Italy · 4 centers

• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 38 — Milan
• Azienda Ospedale Università Padova, Investigational Site Number : 380001 — Padua
• Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003 — Rome
• A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroentero — Turin

France · 3 centers

• Investigational Site Number : 2500001 — Créteil
• Investigational Site Number : 2500002 — Montfermeil
• Investigational Site Number : 2500003 — Pessac

Poland · 3 centers

• Investigational Site Number : 6160004 — Bydgoszcz
• Investigational Site Number : 6160003 — Warsaw
• Investigational Site Number : 6160002 — Warsaw

Sweden · 3 centers

• Investigational Site Number : 7520001 — Linköping
• Investigational Site Number : 7520002 — Stockholm
• Investigational Site Number : 7520003 — Stockholm

Belgium · 2 centers

• Investigational Site Number : 0560002 — Ghent
• Investigational Site Number : 0560001 — Leuven

Denmark · 2 centers

• Investigational Site Number : 2080003 — Aarhus
• Investigational Site Number : 2080002 — Hvidovre

Hungary · 2 centers

• Investigational Site Number : 3480002 — Budapest
• Investigational Site Number : 3480003 — Székesfehérvár

United Kingdom · 2 centers

• Investigational Site Number : 8260002 — Cambridge
• Investigational Site Number : 8260001 — Oxford

Identifiers

NCT: NCT07156175 · ACT18053 · 2024-519495-83 · U1111-1314-5201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗