Advancing clinical trials in Chronic Spontaneous Urticaria (CSU) requires an operational model built for speed and patient-centered support, especially when protocols rely on patient-reported outcomes for capturing real-time disease burden. Because CSU causes severe, unpredictable flare-ups, keeping participants engaged is critical to trial success.

DelRicht Research combines rapid site startup with dedicated patient oversight to overcome quality data capture hurdles and keep complex immunology studies moving forward.

Surpassing Enrollment Goals & Accelerating Timelines

The U.S. based Phase 2b study evaluated the efficacy and safety of an investigational therapy in adult patients ≥18 years old with a history of CSU who demonstrated an inadequate response to H1-antihistamines.

The studywide enrollment goal was set at 160 patients across 53 participating sites. DelRicht Research was entrusted with enrolling 21.1 participants across seven network sites:

●  Dr. Christie Matter | Prosper, TX
●  Dr. Christopher Kling | Wildwood, MO
●  Dr. Deirdre Hooper | New Orleans, LA
●  Dr. Ira Thorla | Baton Rouge, LA
●  Dr. Michael Lovelace | Louisville, KY
●  Dr. Olabisi Badmus | Charlotte, NC
●  Dr. Pezhman Shoureshi | Smyrna, TN

DelRicht’s site network delivered immediate momentum by achieving First Site Activation (FSA) and First Patient Randomized studywide, led by Dr. Deirdre Hooper. All seven sites averaged a 5.7-day activation-to-screening timeline. Over the 5.5-month enrollment period, the network enrolled 66 participants, achieving 212.3% of the expected enrollment goal.

Ultimately, sites generated a monthly enrollment rate of 1.7 participants per site per month, more than tripling the studywide site average of 0.5. Rachel Hastings, Managing Partner at DelRicht Research added:

“Complex protocols don’t have to mean delayed timelines. Securing First Patient Randomized and maintaining an activation-to-screening timeline under six days set an early momentum that carried through the entire study. Our team’s ability to combine speed with dedicated patient oversight gives sponsors the confidence that critical endpoint data will be delivered on schedule.”  – Rachel Hastings, Managing Partner at DelRicht Research

Overcoming Key Trial Challenges

Complex immunology protocols present operational hurdles that demand strategic site intervention to safeguard data quality and keep patients engaged:

● Strict eDiary Completion Window: The protocol required patients to complete daily Urticaria Activity Score (UAS) entries within a strict evening window timeslot. This specific timeframe created a combination of patient burden and engagement challenges. For some patients, site support outside standard operating hours were needed.

To address this challenge and ensure execution, DelRicht sites deployed proactive engagement and management strategies:

● Proactive Patient Education: Sites conducted upfront onboarding to educate participants on the clinical importance of the daily UAS evening completion window, setting clear expectations from Day 1.
● High-Touch Support: Dedicated study coordinators, paired with automated ePRO reminders and 24/7 support for troubleshooting technical issues.

What This Means for Sponsors and CROs

DelRicht’s execution in this Phase 2b CSU trial provides actionable takeaways for sponsors navigating complex immunology and dermatology studies:

1. Rapid Activation Protects Study Timelines: Achieving First Site Activation and maintaining a sub-6-day screening setup creates early study momentum that de-risks overall enrollment schedules.

2. Proactive Site Engagement Secures Data Integrity: Strict eDiary entry windows succeed when sites actively support patients off-hours rather than relying solely on automated system alerts.

3. Outperforming Industry Averages is Predictable with the Right Partner: Averaging 1.7 patients per site per month versus the trial average of 0.5 demonstrates the value of an embedded research network with built-in patient pipelines.

Your Partner in Dermatology and Immunology Research

By blending rapid activation, robust recruitment pipelines, and dedicated patient support, DelRicht Research repeatedly demonstrates how high-performing site networks exceed sponsor expectations in complex clinical trials.

To learn more about partnering with DelRicht Research for upcoming clinical programs in dermatology, immunology, or general medicine, visit www.DelRichtResearch.com or reach out to our business development team.