Sanofi terminates phase 2 trial of SAR441566 in Crohn's disease

Sanofi has terminated a phase 2 study of its oral drug SAR441566 in adults with moderate to severe Crohn's disease, according to a ClinicalTrials.gov record last updated on 2026-10-13. The registry lists the overall status as terminated, with the reason given as a business decision.¹

The trial, registered as NCT06637631 and known by the acronym SPECIFI-CD, was designed as a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating SAR441566 in adults with moderate to severe Crohn's disease.¹

According to the record, the study started on 2024-12-10, with primary completion listed as 2026-07-30 and study completion as 2026-10-02.¹ It was first posted on 2024-10-15.

The design called for an anticipated duration of up to 59 weeks, including a 4-week screening period, a 52-week Main Study treatment period split into 12 weeks of induction and 40 weeks of maintenance, and a 2-week follow-up for those not continuing into a long-term safety study.¹ An additional open-label period of up to 40 weeks was to be offered to eligible participants, with combined double-blind maintenance and open-label time capped at 40 weeks.¹

The trial enrolled 105 participants across arms testing three doses of SAR441566 against placebo, administered as oral tablets.¹

The primary outcome was the proportion of participants achieving endoscopic response at week 12, defined as a 50% or greater reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease.¹ Secondary outcomes included clinical remission by CDAI, PRO-2 remission, and pharmacokinetic and safety measures through week 52.

The study had been conducted at 141 sites across 24 countries, including the United States, Argentina, Brazil, China, India, Japan and South Korea.¹ Sanofi is listed as the lead sponsor.