Co-creating a Phase 2 HS clinical trial with patient experts

Hidradenitis suppurativa (HS) is a severe chronic skin condition characterized by inflamed and swollen lumps that are often painful and can break open, creating significant physical and psychological burden. To ensure a planned Phase 2 clinical trial reflected patients’ real-world needs, Almirall engaged HS patient experts early to challenge and strengthen the draft protocol.

Collect meaningful, actionable patient insights on disease burden, trial experience, PROs, recruitment and retention and translate them into a stronger, more patient-centric Phase 2 protocol.

What began as a one-time HS advisory board has grown into Almirall’s permanent HS Patient Council, regularly consulted on important decisions in HS clinical studies. In partnership with Almirall and five patient advocacy groups, admedicum designed and ran the co-creation process—defining objectives and discussion guides, recruiting and briefing patient experts, facilitating the virtual advisory board, and synthesizing insights into clear, actionable recommendations for the Phase 2 synopsis and protocol team. The collaboration strengthened Almirall’s patient-voice strategy, helping ensure trials are designed with patients, not just for patients.

The sponsor of the trial is Almirall S.A. Patient experts participating represented the Danish Hidradenitis Suppurativa Patients’ Association, US-based HS Connect, the Dutch and the Spanish Hidradenitis Patient Association, as well as HS Ireland. Facilitator of the meeting was admedicum GmbH & Co KG (conceptualization, organization and moderation).

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