A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

Conditions

• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zasocitinib (Dose A) — DRUG
  Zasocitinib.
• Placebo — OTHER
  Placebo.

Study Details

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.

Key Dates

Start date

Jan 26, 2026

Status verified

Mar 2026

Primary completion

Feb 22, 2028

Completion

Feb 22, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blinded: Zasocitinib (Dose A)
  Participants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period.
• Placebo Comparator: Double-blinded: Placebo
  Participants will receive placebo from Day 1 to Week 16 during the double-blind period.
• Experimental: Open-label: Zasocitinib (Dose A)
  Participants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period.

Primary Outcome Measure

Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75) [ Time Frame: At Week 16 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (15)

Find similar trials in Scottsdale, AZ

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