TRANSLATING CLINICAL TRIAL EXPERTISE

From Dermatology to Gastrointestinal Disorders

Summary

The need for therapeutic innovation across specialties is made evident by the increasing prevalence of immune-mediated inflammatory diseases (IMIDs). Through common immunopathology, primarily the dysregulation of cytokines like TNF-α, IL-12/23, IL-17, and JAK/STAT pathways, dermatology and gastroenterology are closely related. Ustekinumab and risankizumab, two medications first licensed for psoriasis, have effectively made the switch to gastrointestinal illnesses (GI) like Crohn’s disease (CD) and ulcerative colitis (UC) (Feagan et al., 2016; Sandborn et al., 2022; D’Haens et al., (2022).

Because of this overlap, Contract Research Organizations (CROs) with a strong background conducting trials in dermatology have a unique opportunity to expand expertise into the GI space. Symbio, a specialized CRO with over 500 completed dermatology trials, is recognized as the leader in that therapeutic area. Our proven operational excellence in managing complex immune-mediated trials, which includes handling biologics, adopting strategic recruitment plans, navigating regulatory landscapes, and leveraging real-world data, positions us to deliver the same high level of performance to GI clients, whether they are entering the space or seeking to optimize ongoing programs.

This article explores:

The scientific rationale for dermatology-GI synergy
Shared immune pathways and therapeutic convergence
Operational advantages of leveraging dermatology expertise in GI studies
Key challenges in GI trials and our tailored solutions
Strategic steps taken to establish robust GI capabilities

By bridging derm and GI expertise, Symbio empowers sponsors to accelerate timelines, enhance patient retention, and ensure high-quality data delivery in an increasingly competitive therapeutic landscape.

Introduction: The Inflammatory Connection

Among the fastest-growing therapeutic markets are IMIDs specifically psoriasis, hidradenitis suppurativa (HS), CD, and UC. By 2032, the global inflammatory bowel disease (IBD) market is expected to grow to $23 billion (GlobalData, 2024), driven by new small molecules that target the JAK and IL-23 pathways as well as biologics (Fortune Business Insights 2024).

This rapid market expansion reflects not only growing patient populations and therapeutic demand but also an evolving understanding of shared inflammatory mechanisms across IMIDs. As research advances, clinical and molecular overlaps among conditions such as CD, UC, and psoriasis have become increasingly evident, guiding both drug development and regulatory strategies. These parallels are reshaping clinical trial design and accelerating cross-indication drug approvals.

There is a clear clinical convergence:

CD and psoriasis both have increased IL-23 and IL-17 signaling.
Biologics cross-indication approvals: Ustekinumab, initially for psoriasis, received FDA approval for CD in 2016 and UC in 2019 (FDA, 2019) (Table 1).
Pipeline shift: Psoriasis trials serve as early efficacy indicators for GI programs (ECCO 2025 highlights).

This overlap underscores why CROs with dermatology expertise have a competitive edge in entering GI space. Complex biologic processing, patient enrollment in chronic IMIDs, and biomarker workflows are examples of established strengths that can be directly translated.

Understanding IBD Pathogenesis as an example

Gastrointestinal diseases range from functional disorders to chronic inflammatory conditions. One of the most clinically significant example is IBD, which includes CD and UC. Unlike transient GI disturbances, IBD is characterized by persistent, relapsing inflammation of the intestinal mucosa, often leading to complications such as strictures, fistulas, and increased colorectal cancer risk.

The pathogenesis of IBD remains incompletely understood but involves a multifactorial interplay of genetics, environmental triggers, gut microbiome dysbiosis, and immune dysregulation. More than 200 susceptibility loci: including NOD2, ATG16L1, and IL23R highlight the role of genes regulating innate immunity and cytokine signaling. However, environmental and epigenetic factors, such as repeated antibiotic exposure, urbanization, Western diets, and smoking (a key risk factor for CD), are critical in shaping disease onset.

These factors disrupt the gut microbiome and weaken epithelial barrier integrity, allowing microbial translocation into the intestinal wall. This triggers an abnormal activation of innate immune cells (neutrophils, macrophages, dendritic cells, innate lymphoid cells), leading to excessive production of pro-inflammatory cytokines and activation of signaling cascades:

TNF-α amplifies inflammation, epithelial apoptosis, and immune cell recruitment.
IL-12/IL-23 pathways drive Th1 and Th17 cell differentiation via STAT4 and STAT3 signaling.
IL-17, IL-22 perpetuate barrier dysfunction and neutrophil influx, while IFN-γ enhances antigen presentation and macrophage activity.

The result is a self-perpetuating inflammatory loop as shown in Figure 1 involving innate and adaptive immunity, culminating in chronic mucosal inflammation and tissue damage (Stallmach et al., 2023).

Figure 1: The immune pathogenesis of inflammatory bowel disease. Figure adopted from (Stallmach et al., 2023).

Cross-Indication Expansion of Immunomodulators

The therapeutic overlap between dermatology and gastroenterology is evident in the growing number of drugs that have transitioned from treating psoriasis and psoriatic arthritis to addressing IBD. Biologics targeting IL-12/23 (e.g., ustekinumab) and selective IL-23 inhibitors (e.g., risankizumab, guselkumab, mirikizumab) dominate this trend, reflecting the pivotal role of Th1 and Th17 pathways in both conditions (FDA (2016), (2019) (2022, 2023)). Additionally, JAK inhibitors (tofacitinib, upadacitinib) have emerged as oral options for UC and CD, while anti-TNF agents remain foundational therapies (Sandborn, et al. (2017).). Pipeline innovation is extending beyond cytokine blockade, with novel targets like TL1A (afimkibart) and LANCL2 (omilancor) under investigation, signaling a shift toward next-generation precision treatments (Table 1).

Table 1: Emerging derm-origin therapies in GI, including three novel mechanisms (TL1A, LANCL2, TYK2). This list is comprehensive as of mid-2025, reflecting current late-stage and approved candidates.

Drug (Brand)	Dermatology Use	GI Indication	Mechanism / Target	Approval / Trial Status
Ustekinumab (Stelara®)	Psoriasis, PsA	CD (2016), UC (2019)	IL-12/23 p40 mAb	Approved for both CD & UC
Risankizumab (Skyrizi®)	Psoriasis, PsA	CD (2022), UC (2024)	IL-23 p19 mAb	Approved for CD & UC
Guselkumab (Tremfya®)	Psoriasis, PsA	UC & CD (2025)	IL-23 p19 mAb	UC approved; CD approved in March 2025
Mirikizumab (Omvoh®)	Psoriasis (pending)	UC (approved), CD (BLA submitted)	IL-23 p19 mAb	UC approved; CD under review
Tofacitinib (Xeljanz®)	PsA, Atopic Dermatitis	UC (2018)	JAK inhibitor	Approved for UC
Upadacitinib (Rinvoq®)	PsA, Atopic Dermatitis	UC & CD	JAK1 inhibitor	Approved for UC & CD
Infliximab, Adalimumab, Certolizumab	Psoriasis, PsA	CD, UC	TNF-α inhibitors	Widely approved in GI
Afimkibart (RO7790121)	Atopic Dermatitis	UC (Phase III), CD (Phase II)	Anti–TL1A mAb	Phase III UC, Phase II CD
Omilancor (BT‑11)	Psoriasis (experimental)	CD & UC (preclinical/early)	LANCL2 activator	In IBD clinical trials

Expertise Transfer: Why Our Derm Experience Matters

Given the shared mechanisms and treatment approaches in dermatology and gastroenterology, it’s no surprise that clinical trial execution in both areas also follows closely aligned strategies. Symbio’s extensive experience in dermatology trials, specifically in rare disease and debilitating disease trials, provides a valuable framework for designing and executing complex gastroenterology studies. These therapeutic areas often face overlapping challenges, particularly in the context of IMIDs which demand chronic disease management, long-term patient engagement, and increasingly patient-centric trial designs. Key shared challenges and Symbio developed strategies include:

Patient Recruitment and Retention: Leveraging digital platforms, patient advocacy networks, and disease registries, especially those focused on IMIDs, can accelerate enrollment timelines by 20–30%. Tailored outreach strategies that resonate with diverse patient populations further enhance recruitment and retention across both therapeutic areas.
Complex Sample Handling: Experience with dermatological biopsies and biomarker analysis informs our handling of complex GI samples such as
Regulatory Expertise: Proficiency in biologic Investigational New Drug (IND) and Investigational Medicinal Product (IMP) submissions ensures compliance with evolving global regulatory requirements, including those from the FDA, EMA and PMDA. This cross-functional expertise is critical in early-phase to late-stage trials involving advanced therapeutics.
Decentralized and Hybrid Trial Models: Given the long duration and burden of participation in GI studies, particularly for chronic conditions, decentralized approaches such as at-home sampling, telemedicine visits, and digital symptom tracking have proven effective in improving patient experience and trial continuity. Many of these models were initially validated in dermatology trials and are now successfully adapted for GI protocols.
Disease Fluctuation and Endpoint Variability: Both dermatology and gastroenterology trials must account for disease variability over time. This requires flexible visit schedules, adaptive trial designs, and the integration of real-world data (RWD) to capture meaningful clinical outcomes.
Patient-Reported Outcomes (PROs) and Quality of Life Metrics: In both areas, PROs are critical to evaluating treatment benefit beyond clinical signs. Tools tailored to each condition, whether assessing skin symptoms or GI-related discomfort, are increasingly central to trial endpoints and regulatory submissions

Long-Term Partner: Why Partner with Symbio

At Symbio, we are more than just a specialized CRO, we are your trusted strategic partner. Our commitment goes beyond simply executing trials; we work collaboratively with our clients to build long-term partnerships by tailoring our approach to align with your goals and expectations. Over the past 20 years, we’ve been fortunate to maintain exceptionally low staff turnover, ensuring consistency and continuity, the same dedicated team that launches your trial is there to celebrate its successful completion. This is a rare advantage in today’s CRO industry.

Thanks to our deep expertise in dermatology, we’ve had the privilege of supporting repeat clients across other therapeutic areas. This trust has naturally fueled our strategic expansion into gastroenterology, where we’ve built specialized capabilities to meet the distinct demands of GI trials

Strategic Expansion into Gastroenterology

To ensure readiness and excellence in GI trials, we’ve made targeted investments in the following key areas:

Site Partnerships: Established collaborations with IBD centers and site networks and independent research organizations across the globe
Patient Advocacy Groups: Established partnerships with key groups such as Crohn’s and Colitis foundations, ECCO (IBD) and Apfed (eosinophilic esophagitis) across U.S. and Europe.
GI Expertise: Partnered with experienced gastroenterology Key Opinion Leaders and onboarded full-time staff with extensive backgrounds in GI clinical trials.
Advanced Imaging Vendors: Built partnerships for centralized reading of endoscopic endpoints.
Specialized Training: Our teams are trained in scoring systems such as Mayo and to ensure consistent and accurate data interpretation.

We understand what it takes to successfully execute complex GI studies. Our approach is grounded in proactive risk identification and the implementation of strategic, risk-based solutions, including mitigation planning and built-in contingencies.

Challenges in GI Trials – and How We Solve Them

Recruitment Barriers: Overcome through pre-screening algorithms, close engagement with patient advocacy organizations (e.g., EFCCA), and partnerships with high-performing sites known for rapid startup timelines
Long Trial Durations: Our patient retention strategies consistently achieve >85% completion rates in chronic IMID trials.
Complex Endpoints: Seamless integration of imaging data is ensured through established collaborations with specialized imaging vendors
Regulatory Complexity: Regional and global compliance is managed by our dedicated QA team experienced in navigating regional and global regulatory requirements

Conclusion

The era of therapeutic convergence demands CRO partners that understand the nuances of IMID trials. Symbio offers proven dermatology-driven expertise, now amplified for GI. With strong operational foundations, scientific rigor, and global infrastructure, we are the ideal partner for gastroenterology development programs.

References

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Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. (2022). Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn’s Disease: The IM-UNITI Trial. Clinical Gastroenterology and Hepatology. 2022 Mar;20(3):578–590.e4.
Fortune Business Insights. (2024). Inflammatory bowel disease treatment market size, share & COVID-19 impact analysis, by drug type (TNF inhibitors, aminosalicylates, and others), by disease indication (ulcerative colitis and Crohn’s disease), by route of administration (injectable and oral), by distribution channel (hospital pharmacy, retail pharmacy, and online pharmacy), and regional forecast, 2024–2032.
D’Haens, G., Panaccione, R., Baert, F., Bossuyt, P., Colombel, J. F., Danese, S., Sandborn, W. J. (2022). Risankizumab as induction therapy for Crohn’s disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. The Lancet, 399(10340), 2015–2030.
Stallmach, A., Atreya, R., Grunert, P. C., Stallhofer, J., de Laffolie, J., & Schmidt, C. (2023). Treatment strategies in inflammatory bowel diseases. Deutsches Ärzteblatt International, 120, 768–778.
Sandborn, W. J., Su, C., Sands, B. E., D’Haens, G. R., Vermeire, S., Schreiber, S., & Panés, J. (2017). Tofacitinib as induction and maintenance therapy for ulcerative colitis. The New England Journal of Medicine, 376(18), 1723–1736
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