Sanofi terminates Phase 2 SPECIFI-UC trial of SAR441566 in ulcerative colitis

Sanofi has terminated a Phase 2 trial of its oral drug SAR441566 in adults with moderate-to-severe ulcerative colitis, according to a clinical trial registry record last updated October 21, 2026. The listing gives the overall status as terminated, with the reason recorded as a business decision.¹

The study, known as SPECIFI-UC (NCT06867094, sponsor ID DRI17822), began on March 28, 2025. Primary completion was recorded as August 6, 2026, with overall study completion listed as October 12, 2026.¹ The trial had been first posted on March 10, 2025.

The randomized, double-blind, placebo-controlled design tested three dose regimens of SAR441566 against placebo in tablet form. The primary objective was to assess the efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.¹ The protocol called for a screening period of up to 28 days, with a possible 7 additional calendar days if needed, followed by a 52-week double-blind treatment period combining 12 weeks of induction and 40 weeks of maintenance, plus a 2-week follow-up after treatment ended.¹ An open-label period of up to 40 weeks was also offered to eligible participants not enrolling in a separate long-term safety study.¹

The primary endpoint was the proportion of participants achieving clinical remission at Week 12 by modified Mayo Score, defined as a score of 2 or less with no subscore above 1, including specific thresholds for stool frequency, rectal bleeding, and endoscopic subscore.¹

The trial enrolled 170 participants¹ across 117 sites in 24 countries, including the United States, Argentina, Australia, and several European and Asian nations.¹ The registry record does not provide additional detail on the business rationale behind the termination.