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SAR442970

Phase 2

Crohn's Disease | Small molecule | Gastrointestinal |Sanofi|Last Updated: Apr 23, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

SAR442970 · 3 trials · 3 indications

Phase 2 3
NCT06975722A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative ColitisUlcerative Colitis
RECRUITING99 Analytics
NCT06958536A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's DiseaseCrohn's Disease
RECRUITING99 Analytics
NCT05849922A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED86 Analytics
PHASE2RECRUITING
A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
PHASE2RECRUITING
A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Crohn's DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)
At Week 16

Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity.

Percentage of participants who achieve endoscopic response at Week 16
From Baseline to Week 16

Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16
Week 16

The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as \>=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. Percentages are rounded off to the tenth decimal place.

Secondary Endpoints

Proportion of participants who achieve endoscopic improvement at Week 16
At Week 16
Proportion of participants who achieve endoscopic improvement at Week 52
At Week 52
Proportion of participants who achieve endoscopic response at Week 16
At Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR442970 Dose Regimen AEXPERIMENTALParticipants will receive SAR442970 dose regimen A
SAR442970 Dose Regimen BEXPERIMENTALParticipants will receive SAR442970 dose regimen B
PlaceboPLACEBO_COMPARATORParticipants will receive SAR442970-matching placebo
SAR442970EXPERIMENTALParticipants received SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).

Interventions

NameTypeDescription
SAR442970DRUGRoute of administration: Subcutaneous
PlaceboDRUGRoute of administration: Subcutaneous
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent * Participants who have had clinical evidence of active UC for ≥3 months b...

Countries:United StatesAustraliaChinaCzechiaFranceGermanyHungaryJapanMoldovaPolandSpainUnited KingdomBelgiumSouth AfricaCanadaChileDenmarkGreeceItalyNetherlandsSweden
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Frequently asked questions about SAR442970

What is SAR442970 used for?

SAR442970 is an investigational small molecule being developed for Hidradenitis Suppurativa, Crohn's Disease, and Ulcerative Colitis. It is currently in Phase 2 clinical trials for these conditions.

Who makes SAR442970?

SAR442970 is being developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting Phase 2 clinical trials for the drug in Hidradenitis Suppurativa, Crohn's Disease, and Ulcerative Colitis.

What phase is SAR442970 in?

SAR442970 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed for Hidradenitis Suppurativa, Crohn's Disease, and Ulcerative Colitis.

What clinical trials is SAR442970 in?

SAR442970 has three Phase 2 trials. NCT05849922, a completed study in Hidradenitis Suppurativa with 86 participants. NCT06958536, a recruiting study in Crohn's Disease with 99 participants. NCT06975722, a recruiting study in Ulcerative Colitis with 99 participants.

Is SAR442970 being tested in ulcerative colitis?

Yes, SAR442970 is being tested in Ulcerative Colitis. The Phase 2 trial NCT06975722 is recruiting adult participants with Ulcerative Colitis across multiple countries, including the United States, Australia, China, and Japan.

Is SAR442970 being tested in Crohn's disease?

Yes, SAR442970 is being tested in Crohn's Disease. The Phase 2 trial NCT06958536 is recruiting adult participants with Crohn's Disease in countries such as the United States, Australia, Belgium, China, and Japan.