NCT07244263

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

StatusActive, Not Recruiting

PhasePhase 2

SponsorTakeda

Primary completionFeb 5, 2027 (estimated)

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 3, 2026 Primary completion moved earlier from Feb 22, 2028 to Feb 5, 2027
- Enrollment closed, study ongoing
- Trial sites reduced: 49 → 45 locations
- Enrollment target: estimated 90 to confirmed 91
Notable Oct 30, 2026 Eligibility criteria expanded, about 55 words
- Trial status: Recruiting to Active, Not Recruiting
- Study sites: 49 to 45
- Secondary endpoints: details revised at 1 of 2 entries
Minor Mar 5, 2026 Site details revised at 13 of 49 sitesv5
Notable Feb 2, 2026 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Feb 6, 2026 to Jan 26, 2026
- Site details revised at 49 of 49 sites
v4
Minor Dec 23, 2025 Site contacts updated at 4 of 49 sitesv3
Nov 26, 2025 Study Status, Referencesv2
Nov 17, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75)

Timeframe: At Week 16

Secondary (2)

Percentage of Participants who Achieve 50% Reduction in HiSCR50

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Arms and interventions

Double-blinded: Zasocitinib (Dose A)Experimental

Participants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period.

Double-blinded: PlaceboPlacebo comparator

Participants will receive placebo from Day 1 to Week 16 during the double-blind period.

Open-label: Zasocitinib (Dose A)Experimental

Participants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period.

Drugs: Zasocitinib (Dose A)

Other: Placebo

Sites

45 sites in 8 countries

United States 15, Canada 6, Australia 5, China 5, Poland 5, France 4, Germany 4, Netherlands 1

About this trial

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.

Trial details

Enrollment: 91 participants (actual)
Started: Jan 26, 2026
Study completion: Feb 22, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Hidradenitis Suppurativa
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa
First posted: Nov 24, 2025
Registry updated: Nov 4, 2026
Last verified: Nov 2026

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