P2681 - Proactive Patient Engagement to Optimize the VICTRIVA Trial Protocol for Dual Targeted Therapy With Vedolizumab and Upadacitinib in Patients With Crohn’s Disease
Shashi Adsul, MD, MBA1, Pooja Oberai, MD1, Stephen Jones, MBBS, BSc2 1Takeda, Cambridge, MA; 2Takeda, UK, England, United Kingdom
Introduction: Dual targeted therapy (DTT) can potentially improve remission rates in patients with Crohn’s disease (CD) as targeting ≥1 pathogenic pathway may provide an additive or synergistic effect. The VICTRIVA study aims to evaluate the efficacy and safety of DTT (vedolizumab [VDZ] plus upadacitinib [UPA]) compared with VDZ alone for the treatment of patients with moderately-to-severely active CD. Taking a patient-centric approach early in the development of clinical trials and understanding from the patient’s perspective the barriers to clinical trial participation is critical. We discuss the proactive patient engagement approach used during the development of the protocol and study materials.
Methods: VICTRIVA (NCT06227910) is a global phase 3b, double-blind, randomized, controlled, 52-week trial in biologic naïve and biologic-experienced adult patients with CD. During protocol development, 75-minute, double-blind interviews of patients with CD were conducted to gain qualitative insights about patients’ perception, hesitation, motivation, and other factors influencing their willingness to participate in the study, with particular emphasis on optimizing the study design. The interview participants (pts) were members of Inspire, a global online patient community forum.
Results: A total of 6 pts were interviewed (US, n=4; UK, n=2; age: 21-59 years; 50% active CD, 50% remission). Pts reacted positively to the trial design, especially the optional substudies. Study endpoints were viewed positively. Pts appreciated the list of permitted medications for existing conditions and CD rescue. Patient-reported outcomes (PROs) were considered valuable and the mobile phone application and schedule for completing PROs was perceived positively. CD-specific quality of life measurements were well perceived. Pts were willing to complete all clinical procedures; however, colonoscopies could pose a barrier for some patients due to the perceived invasiveness and required preparation. Recommendations included: emphasizing the substudies were to offer patients an alternative to dropping out, discussing the safety of VDZ and UPA individually to ease patient concerns about DTT, and clarifying the trial terminology.
Discussion: All pts were willing to consider participating in the trial, especially those with active CD. Proactively engaging patients to gain insights on barriers to enrolment identified opportunities to improve the study design and optimize patient recruitment.
Disclosures:
Shashi Adsul: Takeda – Employee, Stock Options.
Pooja Oberai: Takeda – Employee, Stock Options.
Stephen Jones: Takeda – Consultant.
Shashi Adsul, MD, MBA1, Pooja Oberai, MD1, Stephen Jones, MBBS, BSc2. P2681 - Proactive Patient Engagement to Optimize the VICTRIVA Trial Protocol for Dual Targeted Therapy With Vedolizumab and Upadacitinib in Patients With Crohn’s Disease, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
