The sponsor contracted ICON to conduct a randomised trial using a traditional site based approach to identify the target dose and investigate the safety, tolerability and efficacy of three doses of an investigative compound administered subcutaneously for the treatment of lupus nephritis. The study was to be conducted across 22 countries with approximately 120 patients and included a 52-week treatment period, an 8-week follow-up period and a minimum of 18 on-site visits. Assessments included a full physical examination, ensuring the patient could self-administer the compound and report on adverse events, checking vital signs, labs/urine, ePRO, pK, ECG and an optional renal biopsy.

ICON provided the sponsor with a proposal for the traditional design they had requested but also proposed an alternative hybrid model that would require adjustments in the protocol operationally and maintain the designated endpoints. This proposed model would potentially reduce patient burden and increase retention for the study.

The hybrid model minimised the number of clinic visits by deploying In-home healthcare visits to reduce the amount of travel required and make it easier for the patient to participate. Instead of 18 on-site visits in the traditional design, the hybrid model included only five, with the rest conducted remotely. The trial design dictated that visits one to three were on-site ensuring there was a full physical examination and that the investigational product was presented and explained in detail to the patient. From visit four to ten In-home visits were facilitated with the patient returning to site for visit 11 and 16 for physician examination and medical oversight and final visit 18 to close out the study via telemedicine. The introduction of In-home visits reduced the need for the patient to leave their home, minimised work absenteeism and reduced time travelling to and at the site by approximately half.

ICON developed a customised digital recruitment strategy and appointed Accellacare, its global clinical site network, to attract and engage the target population. Symphony Clinical Research, ICON’s provider of in-home healthcare solutions, conducted the remote visits. ePROs were programmed to be administered in order per protocol and prior to drug dosing to ensure compliance. Reminders were subsequently set up to be sent to patients for drug dosing, tapering of SOC and questionnaire completion, which were then followed up by a direct to patient services team.

The tailored digital recruitment strategy resulted in rapid patient recruitment and Accellacare succeeded in reducing the trial timelines. Remote visits with home healthcare increased patient satisfaction and retention and the use of ePROs reduced the burden on both patients and sites. Reminders and direct patient contact also increased patient compliance and retention.