DUVAKITUG for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development"}
• {"criterion_text":"- Confirmed diagnosis of moderately to severely active Crohn’s Disease (CD) for at least 3 months prior to baseline"}
• {"criterion_text":"- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)"}

Exclusion criteria

• {"criterion_text":"- Participants with Ulcerative Colitis (UC) or indeterminate colitis"}
• {"criterion_text":"- Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum"}
• {"criterion_text":"- Prior or current high-grade gastrointestinal (GI) dysplasia"}
• {"criterion_text":"- Participants on treatment with but not on stable doses of conventional therapy prior to baseline"}
• {"criterion_text":"- Participants receiving prohibited medications or therapies"}
• {"criterion_text":"- Participants with previous exposure to anti-TL1A investigational therapy"}

Primary endpoints

• {"endpoint_text":"- Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12","definition_or_measurement_approach":"Clinical remission measured per Crohn’s Disease Activity Index (CDAI) at Week 12"}
• {"endpoint_text":"- Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12","definition_or_measurement_approach":"Endoscopic response measured by Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12"}
• {"endpoint_text":"- Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12","definition_or_measurement_approach":"Clinical remission per the 2-item patient-reported outcome (PRO-2) at Week 12"}
• {"endpoint_text":"- Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12","definition_or_measurement_approach":"Endoscopic response measured by SES-CD at Week 12"}

Secondary endpoints

• {"endpoint_text":"- Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12","definition_or_measurement_approach":"Clinical response measured by CDAI at Week 12"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12","definition_or_measurement_approach":"Combined endpoint: CDAI clinical response and SES-CD endoscopic response at Week 12"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants achieving endoscopic SES- CD remission at Week 12","definition_or_measurement_approach":"Endoscopic remission assessed by SES-CD at Week 12"}
• {"endpoint_text":"- Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12","definition_or_measurement_approach":"Clinical remission per PRO-2 at Week 12 (US/FDA)"}
• {"endpoint_text":"- Sub-study 2: EU/EMA: Proportion of participants achieving clinical remission per CDAI at Week 12","definition_or_measurement_approach":"Clinical remission measured by CDAI at Week 12 (EU/EMA)"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12","definition_or_measurement_approach":"Absence of ulcers on endoscopy at Week 12 in participants with baseline ulcers"}
• {"endpoint_text":"- Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12","definition_or_measurement_approach":"Change from baseline in PROMIS-Fatigue Short Form 7a T-score at Week 12"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants achieving CDAI clinical response at Week 4","definition_or_measurement_approach":"CDAI clinical response measured at Week 4"}
• {"endpoint_text":"- Sub-study 2: US/FDA: Proportion of participants achieving corticosteroid free remission (in the subset of participants with corticosteroids at baseline) per CDAI at Week 12","definition_or_measurement_approach":"CDAI-defined corticosteroid-free remission at Week 12 in participants on corticosteroids at baseline (US/FDA)"}
• {"endpoint_text":"- Sub-study 2: EU/EMA: Proportion of participants achieving corticosteroid free remission per PRO-2 (in the subset of participants with corticosteroids at baseline) at Week 12","definition_or_measurement_approach":"PRO-2-defined corticosteroid-free remission at Week 12 in participants on corticosteroids at baseline (EU/EMA)"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants achieving CDAI clinical remission and endoscopic remission (SES-CD) at Week 12","definition_or_measurement_approach":"CDAI clinical remission plus SES-CD endoscopic remission at Week 12"}
• {"endpoint_text":"- Sub-study 2: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12","definition_or_measurement_approach":"Change from baseline in IBDQ total score at Week 12"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants with no bowel urgency by Numeric Rating Scale (NRS) at Week 12","definition_or_measurement_approach":"Proportion reporting no bowel urgency by NRS at Week 12"}
• {"endpoint_text":"- Sub-study 2: Proportion of participants with CD-related hospitalizations by Week 12","definition_or_measurement_approach":"Proportion with Crohn's disease–related hospitalizations by Week 12"}
• {"endpoint_text":"- Sub-study 2: Number of participants with any Treatment Emergent Adverse Events (TEAEs), treatment-emergent adverse event of special interest (TEAESIs), treatment-emergent serious adverse event (TESAEs), and TEAEs leading to permanent study intervention discontinuation","definition_or_measurement_approach":"Counts of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent discontinuation during treatment"}
• {"endpoint_text":"- Sub-study 2: Serum concentrations of duvakitug","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentrations of duvakitug"}
• {"endpoint_text":"- Sub-study 2: Incidence of treatment-emergent Anti-drug Antibodies (ADA) against duvakitug","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies (ADA) during treatment"}

Methods

• Physician referral letters (country-specific physician referral materials provided)
• Patient-facing materials: leaflets and posters (K2 Recruitment materials: Patient Leaflet, Patient Poster)
• Patient Advocacy Fact Sheet (materials provided to advocacy groups / for patient advocacy outreach)
• Patient referral contact letters (materials for referral/contact)
• Site-based recruitment arrangements (K1 recruitment arrangements documents for multiple countries)

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Psi Cro AG

Responsibilities

Clinical Outcomes Assessment Instrument (eCOA), Central Medical Reading or Imaging Reading, Central laboratory, Translation of Clinical Trial Materials (No sponsor QC)

Name

Psi CRO Greece

Responsibilities

Monitoring, regulatory, study startup

Name

ESMS Global Limited

Responsibilities

Centralized 24-Hour Emergency System: eSMS

Name

Teckro Limited

Responsibilities

Application for sites to get access to study documents/Q&A - protocol application

Name

Fisher Clinical Services UK Limited

Name

MARKEN Germany GmbH

Name

Suvoda LLC

Third parties

• {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Clinical Outcomes Assessment Instrument (eCOA), Central Medical Reading or Imaging Reading, Central laboratory, Translation of Clinical Trial Materials (No sponsor QC)","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"Monitoring, regulatory, study startup","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Application for sites to get access to study documents/Q&A - protocol application","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}