Takeda Pharmaceutical has successfully met or exceeded nearly all of its enrollment goals for underrepresented populations in its Phase 3 clinical trial of zasocitinib for psoriasis, completing recruitment six months ahead of schedule. This achievement marks a significant advancement in addressing the historical lack of diversity in dermatological clinical research.
According to LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, the company more than doubled its enrollment target for Hispanic participants and nearly doubled its goal for Black/African American representation. While the trial fell short of its target for Native American participants, enrollment still exceeded representation in the U.S. population.
Breaking New Ground in Psoriasis Research
Psoriasis affects over 7.5 million Americans and approximately 60 million people worldwide. It is a chronic inflammatory disease that has historically been studied in clinical trials predominantly featuring white males, creating significant knowledge gaps in treatment responses across diverse populations.
Zasocitinib represents a potential breakthrough as an oral treatment option, offering a significant advantage over injectable biologics currently dominating the market. This could particularly benefit patients who prefer non-injectable therapies or have barriers to accessing injectable treatments.
The PAVE Framework: A Systematic Approach to Diversity
Takeda's success stems from its implementation of the PAVE framework, which has been integrated into all its trials since June 2022. The framework consists of:
- Partnering with community stakeholders
- Addressing operational barriers
- Verifying goals based on real-world data
- Enhancing the diversity of investigative sites
"For instance, we send out site feasibility questionnaires, which include a question about a site's reported demographics. We also ask about their level of community engagement," Robinson explained.
The company's planning process begins at the protocol synopsis phase, utilizing multiple data sources including literature reviews, real-world evidence, site-reported data, and claims data to establish accurate enrollment goals and determine optimal trial locations.
Community Engagement: Beyond Traditional Approaches
Takeda has expanded beyond conventional health fairs to engage with diverse communities. The company has partnered with organizations like Alpha Phi Alpha Fraternity, the oldest intercollegiate historically African American fraternity, to reach underrepresented populations.
In one notable example, a principal investigator recognized the need to first educate a primarily Latino community about clinical research basics before discussing the specific trial. With Takeda's support, he delivered a presentation in Spanish at a local church, demonstrating the importance of culturally sensitive approaches.
"We are trying to encourage sites to be part of our community engagement efforts, which isn't something we've traditionally asked them about," Robinson noted. "But now, it is part of that early planning when we're focused on diversity in trials."
Addressing Educational Gaps in Dermatology
A significant challenge in dermatological research is the lack of diverse skin representation in medical education. To address this, Takeda incorporated images of diverse skin tones in protocol materials and conducted specialized training sessions led by key opinion leaders in diagnosing skin conditions across different ethnicities.
"Images of skin of color are often missing from medical textbooks, which creates a gap in diagnosis and understanding," Robinson emphasized. The training covered important nuances, such as how psoriasis may appear gray rather than red on darker skin tones.
The company also created a "patient experience workshop" to explore cultural nuances and address potential barriers to clinical trial participation, encouraging sites to consider the unique experiences of diverse patients.
Advocacy Partnerships Amplify Impact
Takeda has leveraged partnerships with patient advocacy groups to extend its reach. The company produced a podcast with the National Psoriasis Foundation explaining its PAVE program and is engaging with other global advocacy organizations to share best practices.
"We wanted to assure patients that we're really taking responsibility for setting this up for success," Robinson said. "We are also meeting with other advocacy groups globally to discuss best practices both of us have realized."
Ongoing Commitment to Inclusivity
Despite these successes, Robinson acknowledges there is more work to be done. For example, while the trial did not establish specific enrollment goals for gender, the company recognizes the need to improve female representation in future studies.
Takeda expects to share the specific data from this trial by the end of 2025. The company's achievements in this Phase 3 psoriasis trial demonstrate that with proper planning, community engagement, and cultural sensitivity, pharmaceutical companies can successfully conduct more inclusive clinical research that better represents the diverse populations affected by disease.
This approach not only improves the scientific validity of clinical trials but also helps address healthcare disparities by ensuring that treatment efficacy and safety are understood across different demographic groups.
