NCT07244263

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hidradenitis Suppurativa (HS) is a skin condition that causes deep, painful bumps on the skin. These bumps usually appear in an area where the skin rubs together. They start as small bumps but may become swollen and red over time. If they fill with pus, these lumps are called abscesses; these can also burst. Over time, the area can get scars and tunnels on or under the skin. Recent studies suggest that the condition may start when hair follicles become damaged and blocked. This impacts the skin and may activate the body's germ-fighting (immune) system. This allows bacteria to grow on the skin which worsens the condition and can cause abscesses. The main aims of this study are to learn how safe zasocitinib is, how well it works and how well adults with HS tolerate it compared with a placebo. The participants will receive the study treatment (either zasocitinib or placebo) for up to 4 months (16 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. After the first 4 months, all participants (also those who initially received placebo) will then receive zasocitinib for up to 8 months (36 weeks). During the study, participants will visit their study clinic 12 times.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Zasocitinib (Dose A)	Zasocitinib.
OTHER	Placebo	Placebo.

Timeline

• Start date: 2026-01-26
• Primary completion: 2028-02-22
• Completion: 2028-02-22
• First posted: 2025-11-24
• Last updated: 2026-03-06

Locations

49 sites across 8 countries: United States, Australia, Canada, China, France, Germany, Netherlands, Poland

Regulatory

• FDA-regulated drug study