A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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 facts

Study ID

NCT07244263

Run by

Takeda

People needed

90

Starts

2026-01-26

Expected to finish

2028-02-22

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant Willingness:
• Participant is willing and able to understand and fully comply with all trial procedures and requirements (including the use of digital tools and applications), in the opinion of the investigator.
• Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.
• Disease Characteristics:
• Participants must have signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to screening, and a diagnosis of HS (confirmed by a dermatologist) at the screening visit with stable HS signs and symptoms for 2 months before screening, as determined by the investigator through interview or medical history.
• Participants should have HS lesions in at least 2 distinct anatomical areas, one of which must be at least Hurley Stage II or III at both screening and Day 1.
• Participants must have a total of greater than or equal to (>=) 5 inflammatory lesions (that is, number of abscesses plus number of inflammatory nodules) at both screening and Day 1.
• Participants must have a history of inadequate response to a previous course of oral antibiotic for treatment of HS or exhibited recurrence, intolerance, or contraindication during that course of oral antibiotic, as assessed by the principal investigator.
• Age and Reproductive Status:
• Participant is aged >=18 years at the time of consent. In the European Union (EU)/European Economic Area (EEA), for participants aged 65 years or older, the investigator must document a favorable benefit-risk assessment to justify the participant's inclusion in the trial.
• Participant meets the following birth control requirement:
• An individual with potential for pregnancy, who is now surgically sterile; OR
• An individual of nonchildbearing potential with laboratory confirmation of postmenopausal status; OR
• If sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial.
• The use of effective contraception will be required for participants assigned male sex at birth.
• In the EU/EEA, for participants who elect to use hormonal contraception as a form of highly effective contraception, the investigator must document a favorable benefit-risk assessment to justify the participant's inclusion in the trial at screening and every 3 months during the trial.
• For participants in the EU/EEA, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission decision as of 10 March 2023 on measures to minimize risk of serious side effects with JAK inhibitors (EMA/142279/2023) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) guideline on Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality as of 26 April 2023.

You may not qualify if…

• Target Disease-Related Exclusions:
• Participant has a draining tunnel count of greater than (>) 20 at screening or Day 1.
• Participant has any other active skin disease or condition (for example, bacterial cellulitis, Candida intertrigo, extensive condyloma) that may, in the opinion of the investigator, interfere with the assessment of HS or participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
• Participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease.
• Participant has a diagnosis of inflammatory conditions other than HS, including but not limited to, psoriasis, psoriatic arthritis, and rheumatoid arthritis.
• Recent/Concurrent Infectious Disease Exclusions:
• Tuberculosis (TB):
• Participants have a history of active TB infection, regardless of treatment status.
• Participants have signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.
• Participants have evidence of latent tuberculosis infection (LTBI) as evidenced by a positive QuantiFERON (QFT) result OR 2 indeterminate QFT results, and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis. Participant remains eligible if there are no signs/symptoms of active TB AND documentation of no history of active TB can be provided AND (1) participant can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines) or (2) participant has a positive QFT result or 2 indeterminate QFT results but has initiated prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. In the EU/EEA, participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (for example, pulmonologist).
• Note: TB prophylaxis regimens should be administered according to local guidelines; however, because of potential interactions with zasocitinib, rifampin should not be used. For isoniazid monotherapy, a minimum of 6 months should be used. TB testing should be conducted using QFT-TB Gold submitted to the central laboratory unless alternate or additional tests are required per local guidelines.
• Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all participants regardless of QFT-TB Gold results unless the participant has had normal chest imaging in the 6 months prior to screening.
• Herpes infections:
• Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1.
• Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
• Nonherpetic viral diseases:
• Participant has presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction [PCR]). In the EU/EEA, if the participant has total anti-HCV antibody positivity at screening but is confirmed to have no detectable HCV RNA by PCR testing, HCV RNA PCR testing will be assessed every 3 months until end of trial (EOT).
• Participant has presence of positive hepatitis B virus surface antigen (HBsAg), or indeterminate HBsAg, presence of HBV DNA (regardless of serology), or positive anti-hepatitis B core antibody (HBcAb) without concurrent positive HBsAb (HBcAb+ and HBsAb-). In the EU/EEA, if the participant has total anti-HBc antibody positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, the participant will repeat HBV DNA PCR testing every 3 months until the EOT; if a participant has anti-HBsAb positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, unless the participant has documented completion of the HBV vaccination series by medical history, the participant will repeat HBV DNA PCR testing every 3 months until the EOT. Note: For other countries in which there are hepatitis B screening guidelines, these can be done per local regulations or country standard of care.
• Participant has positive results for HIV by serology, regardless of viral load.
• Other infectious diseases:
• Participant has a history of active infection or febrile illness within 10 days prior to Day 1, as assessed by the investigator.
• Participant has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1.
• Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous (IV) antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy within 30 days prior to Day 1.
• Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations (except those part of the HS clinical findings)/infections or fungal infections (except ungual onychomycosis).
• Participant has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced at least 60 days prior to Day 1.

Where it is running

• Advanced Clinical Research Institute — Tampa, Florida, United States (enrolling)
• First OC Dermatology Research — Fountain Valley, California, United States (enrolling)
• Johnson Dermatology — Fort Smith, Arkansas, United States (enrolling)
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States (enrolling)
• SimcoDerm Medical and Surgical Dermatology Centre — Barrie, Ontario, Canada (enrolling)
• StracSkin, PLLC — Greenland, New Hampshire, United States (enrolling)
• Apex Clinical Research Center, LLC. — Mayfield Heights, Ohio, United States
• ODRC Enterprises, LLC dba Oregon Dermatology and Research Center — Portland, Oregon, United States
• Arlington Research Center, Inc. — Arlington, Texas, United States
• Texas Dermatology Research Center — Dallas, Texas, United States
• Skin & Cancer Foundation - The Skin Hospital — Darlinghurst, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Skin Health Institute Inc. — Carlton, Victoria, Australia
• Sinclair Dermatology — Melbourne, Victoria, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Beacon Dermatology — Calgary, Alberta, Canada
• Brunswick Dermatology Center — Fredericton, New Brunswick, Canada
• CCA Medical Research — Ajax, Ontario, Canada
• Ryan Clinical Research Inc. — Newmarket, Ontario, Canada
• SKiN Centre for Dermatology — Peterborough, Ontario, Canada
• Innovaderm Research Inc. — Montreal, Quebec, Canada
• DIEX RECHERCHE Quebec — Québec, Quebec, Canada
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Southern Medical Universtiy - Dermatology Hospital (SMUDH) (Guangdong Provincial Dermatology Hospital) — Guangzhou, Guangdong, China
• Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST) — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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