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

Official title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease

Overview

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.

Interventions

• Drug SAR442970
  Route of Administration: Subcutaneous
• Drug Placebo
  Route of Administration: Subcutaneous

Primary outcome measures

• Percentage of participants who achieve endoscopic response at Week 16 [Time frame: From Baseline to Week 16]

Secondary outcome measures (12)

• Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16 [Time frame: At Week 16]
• Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16 [Time frame: At Week 16]
• Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16 [Time frame: At Week 16]
• Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16 [Time frame: At Week 16]
• Percentage of participants who achieve CDAI clinical response at Week 16 [Time frame: At Week 16]
• Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score [Time frame: From Baseline to Week 16]
• Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score [Time frame: From Baseline to Week 16]
• On-treatment serum concentrations of SAR442970 at predefined timepoints [Time frame: Up to End of Study (approximately 164 weeks)]
• 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)]
• Number and percentage of participants with any TEAEs during open-label treatment period [Time frame: Up to Week 52]
• Incidence of Anti-drug Antibodies (ADAs) over time [Time frame: Up to End of Study (approximately 164 weeks)]
• Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 52 [Time frame: At Week 52]

Eligibility criteria

Inclusion criteria

• Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
• Confirmed diagnosis of moderate-to-severe CD
• History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
• On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion criteria

• Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome
• Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
• Participants with following ongoing known complications of CD:

• Any manifestation that might require bowel surgery while enrolled in the study
• Participant with ostomy or ileoanal pouch
• Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
• Participant with surgical bowel resection within the past three months prior to screening, or a history of >3 bowel resections
• History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study

The above information is not intended to contain all considerations relevant to a patient'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

United States · 20 centers

• Investigational Site Number: 8400024 — Tucson
• Investigational Site Number: 8400005 — Escondido
• Investigational Site Number: 8400001 — Lancaster
• Investigational Site Number: 8400017 — Kissimmee
• Investigational Site Number: 8400015 — Lighthouse PT
• Investigational Site Number 8400028 — Miami
• Investigational Site Number: 8400012 — Miami
• Investigational Site Number: 8400007 — Orlando
• … and 12 more centers

China · 8 centers

• Investigative Site: 1560003 — Changsha
• Investigational Site Number: 1560008 — Changsha
• Investigative Site: 1560005 — Changzhou
• Investigational Site Number: 1560001 — Guangzhou
• Investigational Site Number: 1560006 — Hangzhou
• Investigative Site: 1560004 — Nanchang
• Investigative Site: 1560002 — Shanghai
• Investigational Site Number: 1560007 — Shenyang

Japan · 8 centers

• Investigational Site Number: 3920007 — Kashiwa
• Investigational Site Number: 3920005 — Ōita
• Investigational Site Number: 3920006 — Hamamatsu
• Investigational Site Number: 3920004 — Bunkyō City
• Investigational Site Number: 3920003 — Hamamatsu
• Investigational Site Number: 3920009 — Hirosaki
• Investigational Site Number: 3920001 — Morioka
• Investigational Site Number: 3920002 — Nishinomiya

Poland · 7 centers

• Investigational Site Number: 6160002 — Wroclaw
• Investigational Site Number: 6160001 — Krakow
• Investigational Site Number: 6160005 — Lublin
• Investigational Site Number: 6160006 — Sopot
• Investigational Site Number: 6160008 — Warsaw
• Investigational Site Number: 6160003 — Warsaw
• Investigational Site Number: 6160004 — Wroclaw

United Kingdom · 5 centers

• Investigational Site Number: 8260007 — Bury
• Investigational Site Number: 8260004 — Cambridge
• Investigational Site Number: 8260005 — London
• Investigational Site Number: 8260002 — London
• Investigational Site Number: 8260001 — London

Germany · 4 centers

• Investigational Site Number: 2760002 — Minden
• Investigational Site Number: 2760003 — Jena
• Investigational Site Number: 2760004 — Kiel
• Investigational Site Number: 2760001 — Ulm

Australia · 3 centers

• Investigational Site Number: 0360002 — Brisbane
• Investigational Site Number: 0360004 — Kurralta Park
• Investigational Site Number: 0360001 — Footscray

Czechia · 3 centers

• Investigational Site Number: 2030002 — Brno
• Investigational Site Number: 2030003 — Hradec Králové
• Investigational Site Number: 2030005 — Slaný

France · 3 centers

• Investigational Site Number: 2500001 — Montpellier
• Investigational Site Number: 2500003 — Nice
• Investigational Site Number: 2500002 — Toulouse

Spain · 3 centers

• Investigational Site Number: 7240002 — Madrid
• Investigational Site Number: 7240001 — Madrid
• Investigational Site Number: 7240003 — Seville

Belgium · 1 center

• Investigational Site Number: 0560001 — Leuven

South Africa · 1 center

• Investigational Site Number: 7100003 — Johannesburg

Identifiers

NCT: NCT06958536 · DRI18450 · U1111-1306-7510 · 2024-517016-30-00 · DRI18450

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗