A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

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• Crohn Disease 1,880

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 99 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Study arms

• Experimental
  SAR442970 Dose Regimen A

  Participants will receive SAR442970 dose regimen A

  Drug: SAR442970

• Experimental
  SAR442970 Dose Regimen B

  Participants will receive SAR442970 dose regimen B

  Drug: SAR442970

• Placebo comparator
  Placebo

  Participants will receive placebo

  Drug: Placebo

Interventions

• DrugSAR442970

  Route of Administration: Subcutaneous

• DrugPlacebo

  Route of Administration: Subcutaneous

Primary outcomes

1. Percentage of participants who achieve endoscopic response at 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.

   Time frame: From Baseline to Week 16

Secondary outcomes

1. Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16

   CDAI clinical remission is defined as CDAI score \<150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.

   Time frame: At Week 16

2. Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16

   PRO-2 clinical remission is defined as using the average daily Stool Frequency (SF) ≤3 and not worse than baseline and average daily AP ≤1 and not worse than baseline.

   Time frame: At Week 16

3. Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16

   Endoscopic remission is defined as SES-CD ≤4 and at least 2 point reduction versus baseline and no subscore \>1 in any individual variable based on central reading.

   Time frame: At Week 16

4. Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16

   CDAI clinical remission is defined as CDAI score \<150, endoscopic response is defined as a decrease in 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.

   Time frame: At Week 16

5. Percentage of participants who achieve CDAI clinical response at Week 16

   CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.

   Time frame: At Week 16

6. Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score

   The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item instrument assessing health-related quality of life in IBD patients across four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Each question evaluates experiences over the previous two weeks on a 7-point Likert scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224, with higher scores indicating better quality of life. Both domain-specific and overall scores can be calculated.

   Time frame: From Baseline to Week 16

7. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score

   The FACIT-F questionnaire assesses fatigue associated with anemia through 13 fatigue-related questions. Each item is scored on a 5-point Likert scale (0="not at all" to 4="very much"), with total scores ranging from 0 to 52. High scores represent less fatigue. For Crohn's Disease patients, a 7-10 point improvement on the FACIT-F total score may represent meaningful improvements.

   Time frame: From Baseline to Week 16

8. On-treatment serum concentrations of SAR442970 at predefined timepoints

   Time frame: Up to End of Study (approximately 164 weeks)

9. Number and percentage of participants with any Treatment Emergent Adverse Events (TEAEs) during induction, maintenance and Long-term Extension (LTE) treatment period

   Time frame: Up to End of Study (approximately 164 weeks)

10. Number and percentage of participants with any TEAEs during open-label treatment period

    Time frame: Up to Week 52

11. Incidence of Anti-drug Antibodies (ADAs) over time

    Time frame: Up to End of Study (approximately 164 weeks)

12. Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 52

    Endoscopic remission is defined as SES-CD ≤4 and at least 2 point reduction versus baseline and no subscore \>1 in any individual variable based on central reading.

    Time frame: At Week 52

13. Percentage of participants achieving CDAI clinical remission at Week 52

    CDAI clinical remission is defined as CDAI \<150.

    Time frame: At Week 52

14. Percentage of participants achieving CDAI clinical remission at both Week 16 and at Week 52

    CDAI clinical remission is defined as CDAI \<150.

    Time frame: At Week 52

15. Percentage of participants who achieve endoscopic response at Week 52

    Endoscopic response is defined as decrease in 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.

    Time frame: At Week 52

16. Percentage of participants who achieve endoscopic response at both Week 16 and Week 52

    Endoscopic response is defined as decrease in 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.

    Time frame: At Week 52

17. Percentage of participants who achieve CDAI clinical response at Week 52

    CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.

    Time frame: At Week 52

18. Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 52

    CDAI clinical remission is defined as CDAI score \<150, endoscopic response is defined as a decrease in 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.

    Time frame: At Week 52

Related links

• DRI18450 Plain Language Results Summary ↗

Individual participant data

Plan to share: 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.