What is zasocitinib studying for hidradenitis suppurativa?

Zasocitinib is being studied to see how safe and effective it is for treating adults with moderate to severe hidradenitis suppurativa. The trial compares it with a placebo to understand its effects on reducing symptoms. Takeda sponsors this study to help find new treatment options for this condition.

Who may be eligible for this hidradenitis suppurativa clinical trial?

Adults aged 18 years or older diagnosed with hidradenitis suppurativa and having symptoms in at least two body areas may be eligible. Participants should have an inadequate response to prior oral antibiotics and be willing to follow trial procedures. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this hidradenitis suppurativa clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any costs related to getting to the study visits.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07244263

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

Led by Takeda · Updated on 2026-03-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Hidradenitis Suppurativa HS is a skin condition that causes painful bumps, abscesses, scars, and tunnels in areas where the skin rubs together. This condition may start when hair follicles become damaged, triggering the immune system and allowing bacteria to worsen the symptoms. Researchers are evaluating the safety, effectiveness, and tolerance of a drug called zasocitinib in adults with moderate to severe HS compared with a placebo in this Phase 2 clinical trial. Participants will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks in a double-blind period. After this, all participants will receive zasocitinib for an additional 36 weeks in an open-label period. The placebo capsules look like zasocitinib but contain no medicine. Treatment dosing involves a specific dose of zasocitinib labeled as Dose A. During the study, participants will visit the clinic 12 times for assessments. Researchers will monitor the percentage of participants achieving a 75 reduction in HS symptoms at week 16 as the primary outcome. They will also track safety through adverse events and other measures throughout the 56 weeks of treatment. Participants will undergo evaluations including clinical exams, questionnaires, and safety tests to understand treatment effects and tolerability.

CONDITIONS

Brief Title

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant is willing and able to understand and comply with all trial procedures, including use of digital tools
Provided written informed consent before any trial procedures
Diagnosed with hidradenitis suppurativa by a dermatologist with symptoms for at least 6 months and stable signs for 2 months
HS lesions present in at least 2 distinct anatomical areas, with at least one area at Hurley Stage II or III
Has 5 or more inflammatory lesions (abscesses plus nodules) at screening and Day 1
History of inadequate response or intolerance to a previous course of oral antibiotic for HS
Aged 18 years or older at consent; for those 65 or older in EU/EEA, favorable benefit-risk assessment required
Meets birth control requirements if of childbearing potential, including effective contraception use
In EU/EEA, no anticipated risk according to regulatory guidelines regarding JAK inhibitors

You will not qualify if you...

More than 20 draining tunnels at screening or Day 1
Other active skin diseases or conditions interfering with HS assessment
Diagnosed with sarcoidosis, systemic lupus erythematosus, active inflammatory bowel disease, or other inflammatory diseases like psoriasis or rheumatoid arthritis
History or signs of active tuberculosis or latent TB without proper prophylaxis
Active or serious herpes virus infections
Hepatitis C or B infections as specified, or positive HIV serology
Recent or ongoing serious infections, including bacterial, viral, or fungal infections requiring hospitalization or IV treatment
History of opportunistic infections
Clinically significant unstable medical conditions or vital sign abnormalities
History of compromised immunity or new/unstable autoimmune diseases
Major surgery within 60 days before Day 1 or planned during trial
Severe or uncontrolled hypertension
History of severe heart failure or lymphoproliferative disease
Recent serious pulmonary illnesses requiring hospitalization or steroids
Cardiovascular events within 6 months unless benefit-risk assessment supports inclusion
Significant psychiatric illness or recent severe depression or suicidal behavior
Abnormal lab values including blood counts, liver, kidney function, or thyroid hormone levels beyond limits
History of significant drug allergies or allergy to zasocitinib
Pregnancy, lactation, or plans to become pregnant during trial
Substance abuse history within 12 months
Recent blood or plasma donation or planned donation during trial
Trial site employee or dependent relationship with trial staff
Inability to give informed consent as per local regulations
History of malignancy within 5 years except certain treated skin or cervical cancers
History or current substance use or tobacco use disorder unless benefit-risk assessment supports inclusion

Research Team

Takeda Contact

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