The Enrollment Challenge in Hidradenitis Suppurativa Clinical Trials

A Perspective for Sponsors and CROs Planning HS Programs

There has rarely been a more promising time to develop a therapy for hidradenitis suppurativa. After decades with few options, HS has become one of the most active areas of inflammatory dermatology research, with a growing pipeline of biologics and small molecules moving through Phase 2 and Phase 3.

But sponsors who have run an HS program know a hard truth the pipeline excitement can obscure: HS trials rarely struggle because of the science. They struggle at the site, specifically, at enrollment. Recruiting and retaining the right HS patients, and assessing them consistently, is one of the most demanding execution problems in dermatology. The programs that succeed are the ones that solve it deliberately, before the first site is activated.

Why HS Enrollment Is So Hard

Several features of the disease combine to make recruitment unusually difficult:

A largely undiagnosed pool. Patients with HS experience an average diagnostic delay of seven to ten years before receiving an accurate diagnosis. As a result, a substantial share of the eligible population remains hidden within healthcare systems under other diagnoses.

Stigma and disengagement. HS is painful and intimate in its anatomy. Many patients have stepped back from care after years of being dismissed, which makes them hard to reach and slow to trust a research setting.

Narrow, dynamic eligibility. Inclusion typically hinges on lesion counts, Hurley stage, and disease activity within a defined window and HS flares unpredictably.

Assessor-dependent endpoints. HiSCR, IHS4, and lesion counting all depend on consistent, trained assessment. Inconsistent counting inflates screen-fail rates and adds noise to the primary endpoint.

A hard-to-retain population. HS commonly travels with obesity, smoking, and metabolic and psychiatric comorbidities, and these trials run long. Without a deliberate retention strategy, placebo-arm dropout alone can threaten a study’s power.

What That Means for Site Selection

For an HS program, the value of a site network isn’t abstract. It comes down to four questions:

• Can the network reach patients others can’t, including treatment-naive populations who haven’t already cycled through years of therapy?
• Can it assess them consistently, with investigators and coordinators who know HS endpoints cold?
• Can it keep them enrolled through a long, demanding protocol?
• Can it do all of this without burying the sponsor in fragmented contracts and unpredictable site budgets?

How Precefi Is Built for This

Precefi is a site management organization specialized in dermatology, which means HS isn’t an outlier in our portfolio. It’s the kind of condition our model is designed around: high unmet need, difficult recruitment, and execution that rewards specialization.

Many of our dermatology sites have participated in multiple HS clinical trials and maintain active HS patient populations within their routine clinical practices. That means access to patients who are already diagnosed, engaged in care, and familiar with the disease.

A U.S. and Latin American network. Our investigator network spans the United States and Latin America giving sponsors access to patient populations, including treatment-naive patients that can meaningfully accelerate enrollment when U.S. and European recruitment slows.

Operational simplicity. Across the entire network, Precefi operates on a single contract and a single price structure, reducing startup complexity and helping sponsors move from site selection to activation more efficiently.

Why Now

The pipeline’s momentum is a double-edged sword. As more sponsors compete for the same experienced sites and the same hard-to-find patients, capable networks fill their capacity. Sponsors who engage a specialized network early — while planning the program, not after enrollment stalls — protect their timelines.

Let’s Talk

As competition for experienced HS sites continues to grow, sponsors who align with specialized networks early are often best positioned to protect enrollment timelines and study quality. Interested in discussing an upcoming HS study? Contact Precefi to learn more about our dermatology-focused site network.

References
Saunte DM, Boer J, Stratigos A, et al. Diagnostic delay in hidradenitis suppurativa is a global problem. British Journal of Dermatology. 2015;173(6):1546-1549.