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
2 other identifiers
interventional
90
8 countries
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2026
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
January 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2028
March 6, 2026
March 1, 2026
2.1 years
November 17, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75)
HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline.
At Week 16
Secondary Outcomes (2)
Percentage of Participants who Achieve 50% Reduction in HiSCR50
At Week 16
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
From start of study drug up to Week 56
Study Arms (3)
Double-blinded: Zasocitinib (Dose A)
EXPERIMENTALParticipants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period.
Double-blinded: Placebo
PLACEBO COMPARATORParticipants will receive placebo from Day 1 to Week 16 during the double-blind period.
Open-label: Zasocitinib (Dose A)
EXPERIMENTALParticipants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period.
Interventions
Zasocitinib.
Eligibility Criteria
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 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.
- 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:
- 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.
- 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).
- +52 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (49)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
First OC Dermatology Research
Fountain Valley, California, 92708, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Advanced Clinical Research Institute
Tampa, Florida, 33607, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University
Detroit, Michigan, 48201, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
StracSkin, PLLC
Greenland, New Hampshire, 03840, United States
Northwell Health Physician Partners
Lake Success, New York, 11020, United States
Mount Sinai Doctors
New York, New York, 10028, United States
Apex Clinical Research Center, LLC.
Mayfield Heights, Ohio, 44124, United States
ODRC Enterprises, LLC dba Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Texas Dermatology Research Center
Dallas, Texas, 75246, United States
Skin & Cancer Foundation - The Skin Hospital
Darlinghurst, New South Wales, 2010, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Skin Health Institute Inc.
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
Melbourne, Victoria, 3002, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Beacon Dermatology
Calgary, Alberta, T3E 0B2, Canada
Brunswick Dermatology Center
Fredericton, New Brunswick, E3B 1G9, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
Ryan Clinical Research Inc.
Newmarket, Ontario, L3Y 2R2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
DIEX RECHERCHE Quebec
Québec, Quebec, G1V 4T3, Canada
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Southern Medical Universtiy - Dermatology Hospital (SMUDH) (Guangdong Provincial Dermatology Hospital)
Guangzhou, Guangdong, 510091, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, 430022, China
Huashan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, 20040, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 31003, China
CHU NICE
Nice, Alpes Maritimes, 6200, France
APHM
Marseille, Bouches Du Rhone, 13005, France
Cabinet medical du Docteur RUER
Martigues, PACA, 13.5, France
Hopital Edouard Herriot
Lyon, Rhone, 69003, France
Centre Hospitalier Le Mans
Le Mans, Sarthe, 72037, France
CHU de Rouen
Rouen, 76031, France
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455, Germany
Katholisches Klinikum Bochum gGmB
Bochum, Northrhine Westfalia, 44791, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Hautklinik und Poliklinik - Clinical Research Center (CRC)
Mainz, Rhineland-Palatine, 55131, Germany
Charite Dermatology
Berlin, 10117, Germany
ErasmusMC
Rotterdam, South Holland, 3015GD, Netherlands
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak SpAAka Partnerska
Wroclaw, DolnoAlAskie, 50-566, Poland
Klinika Ambroziak Dermatologia
Warsaw, Masovia, 02-953, Poland
PaAstwowy Instytut Medyczny MSWiA
Warsaw, Mazowsze, 02-507, Poland
Klinika Dermatologii, Uniwersytecki Szpital Kliniczny
Rzeszów, Podkarpackie, Poland, 35-055, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z o.o.
Malbork, Pomeranian, 82-200, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 24, 2025
Study Start
January 26, 2026
Primary Completion (Estimated)
February 22, 2028
Study Completion (Estimated)
February 22, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.