Supporting a Global Phase III Urticaria Trial with Clinion EDC, RTSM, and ePRO
Overview
A biotech sponsor partnered with Clinion to support a global Phase III dermatology study in adults with chronic idiopathic urticaria who remained symptomatic despite antihistamine treatment. The study compared efficacy, safety, tolerability, and immunogenicity across multiple treatment groups, requiring controlled randomization, blinded workflows, repeated symptom assessment, and structured safety data capture.
The study relied heavily on patient-reported symptom data, including itch severity, urticaria activity, hives scores, and quality-of-life measures. The sponsor needed a digital setup that could support both site-entered clinical data and patient-reported outcome capture across treatment and follow-up timepoints.
Clinion deployed EDC, RTSM, and ePRO together as one connected environment for the trial. This combination helped the study team manage the trial’s two-stage randomization design, capture continuous patient-reported symptom data, and maintain consistent, blinded data capture across a multi-country site network, from first patient enrollment through study completion.
Study Snapshot
Industry
Biotech
Client
Biotech sponsor
Study Type
Interventional
Therapeutic Area
Dermatology
Study Phase
Phase III
Study Design
Randomized, multicenter, double-blind, four-arm, parallel-group, active-controlled
Randomization
Double blind
Region
Global
Site Count
6 sites
Submission
FDA-regulated drug product, per registry record
Study Duration
Approximately 16 months, per registry record
Challenges
Managing Two-Stage Randomization and Continuous Symptom Reporting Across a Global Trial
The study required coordinated control across randomization, daily patient symptom reporting, and blinded clinical data capture across six sites in three countries. The challenge was keeping these workflows consistent and traceable throughout the main treatment, transition, and follow-up periods.
01
Managing a Two-Stage, Multi-Arm Randomization Design
Patients were randomized across four arms at baseline, with those on the active-comparator arms randomized again at Week 12 to continue or transition to the investigational therapy, per the registry record. This created a need for an RTSM setup built for sequential randomization without breaking the blind.
02
Sustaining Daily and Weekly Patient-Reported Symptom Data
The study depended on daily itch severity diaries and weekly urticaria activity scores across treatment and follow-up. Capturing this patient-reported data consistently across three countries required a reliable ePRO workflow that avoided paper diaries, missed entries, and manual transcription effort.
03
Maintaining Blinded Data Consistency Across a Multi-Country Site Network
The study’s double-blind design had to be maintained across six sites in the United States, India, and Jordan. The sponsor needed a centralized data environment that could support protocol-aligned data capture, consistent site workflows, and blinded review across all participating locations.
Solutions
A Unified Clinion Platform for Randomized Trial Execution and Patient-Reported Data Capture
Clinion deployed an integrated solution combining EDC, RTSM, and ePRO to support the Phase III urticaria study. The combination helped the study team manage sequential randomization, continuous symptom reporting, and blinded data capture from a single connected platform.
Outcomes
Core Results
Clinion’s connected EDC, RTSM, and ePRO environment helped the study team manage randomization, symptom reporting, and blinded data capture across a multi-country Phase III trial.
Randomization Control
RTSM supported blinded allocation across multiple treatment arms and dose groups.
ePRO Data Consistency
ePRO helped capture repeated symptom diary and outcome data in a structured digital format.
Global Study Coordination
Integrated workflows helped connect randomization, ePRO, and clinical data review across countries.
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Compliance
Fully Compliant with Global Standards
