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Hidradenitis SuppurativaPhase 2NCT07244263

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

A Phase 2 study testing Zasocitinib (Dose A) in people with Hidradenitis Suppurativa, run by Takeda at 45 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Zasocitinib (Dose A)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
45 sitesin 8 countries
Study dates
26 Jan 2026to 22 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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:
Show all 75Show fewer
  • 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.
  • Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidiomycosis).
  • Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.
  • Noninfectious Disorders Exclusions:
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurologic, nutritional, ophthalmologic, or immunologic), or vital signs/physical/laboratory/electrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:
  • Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency, splenectomy.
  • Participant has a history of new or unstable autoimmune disease (including but not limited to autoimmune thyroid disease, alopecia areata, lupus, Sjogren's, myasthenia gravis, or rheumatoid arthritis).
  • Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.
  • Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
  • Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
  • Participant has a history of lymphoproliferative disease.
  • For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
  • Participant has any of the following cardiovascular disease history:
  • A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, nonacute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening.
  • Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator documents there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll; in the EU/EEA, investigators must document a favorable benefit-risk assessment.
  • Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
  • Participant has any lifetime history of suicide attempts, or active suicidal ideation or suicidal behavior in the past 5 years, or any diagnosis of severe depression or other unstable psychiatric condition in the last 6 months, based on: (1) medical history; or (2) Columbia-Suicide Severity Rating Scale (C-SSRS) documentation by answering "yes" to Question 4 or 5 for suicidal ideation concerning the previous 5 years before participation on the C-SSRS at screening or Day 1; or (3) is clinically deemed to have a suicide risk by the investigator, or in the opinion of the investigator, would pose an unacceptable risk to the participant's safety or impact their ability to comply with trial procedures.
  • Participant has a score of 15 or above at screening or Day 1 on the 8-item Patient Health Questionnaire-8 (PHQ-8).
  • Participant has a history of active substance abuse or a history of substance abuse within 12 months prior to screening.
  • Laboratory/Physical Exclusions:
  • Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if they participated in the trial, in the opinion of the investigator.
  • Participant has inadequate renal, hepatic, or pancreatic function before enrollment based on the following parameters:
  • Total bilirubin (unconjugated and/or conjugated) >1.5 × upper limit of the normal range (ULN) unless the participant has known Gilbert's syndrome that can explain the elevation of bilirubin, or
  • Serum alanine aminotransferase (ALT) or AST >3 × ULN, or
  • Creatinine >1.5 × ULN. Note: The participant may be retested (1 time) to meet eligibility criteria at the discretion of the investigator.
  • Estimated creatinine clearance lesser than (<)45 milliliter per minute (mL/min) based on the Cockcroft-Gault calculation.
  • A history of chronic pancreatitis or recent acute pancreatitis (<60 days/not fully resolved).
  • Participant has any of the following laboratory values at the screening visit:
  • Hemoglobin <9.0 gram per deciliter (g/dL) (<90.0 gram per liter [g/L]).
  • Absolute white blood cell count <3.0 × 10^9/L (<3000/ cubic millimeters [mm^3]).
  • Absolute neutrophil count (ANC) of <1.0 × 10^9/L (<1000/mm^3).
  • Absolute lymphocyte count of <0.5 × 10^9/L (<500/mm^3).
  • Platelet count <100 × 10^9/L (<100,000/mm^3).
  • Thyroid-stimulating hormone (TSH) (>10 milli-international units per liter [mIU/L]) or free T4 or T3 outside the normal reference range. Note: Participants would be allowed to rescreen after treatment.
  • Triglyceride level >=750 milligram per deciliter [mg/dL] (>=8.5 millimole per liter [mmol/L]).
  • Creatine phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (National Cancer Institute) (CTCAE) Grade 1 or lower (or lesser than or equal to [<=]2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.
  • Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.
  • Participant does not tolerate venipuncture or inability to be venipunctured.
  • Allergies and Adverse Drug Reactions Exclusions:
  • Participant has a history of significant drug allergy (such as anaphylaxis).
  • Participant has a known or suspected allergy to zasocitinib or any of its components.
  • Other Exclusions:
  • Participant has a positive pregnancy test result or plans to become pregnant during the trial period, including plans to donate ova (eggs) or sperm, or participant is pregnant or lactating/nursing.
  • Participant has a history of substance abuse within 12 months prior to Day 1.
  • Participants who have given greater than 500 mL of blood or plasma within 30 days prior to screening (during a clinical trial or at a blood bank donation) or plan to donate blood during the course of the trial.
  • Participant is compulsorily detained for treatment of either a psychiatric or physical (for example, infectious disease) illness, or is committed to an institution (for example, prison) by virtue of an order issued either by judicial or administrative authorities.
  • Participant is a trial site employee, an immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with trial site employee who is involved in the conduct of this trial or may consent under duress.
  • In Germany, participant is incapable of giving consent or otherwise meets criteria in Sections 136 or 137 of the Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung Strahlenschutzverordnung.
  • Participants with a history of malignancy within the past 5 years prior to the screening visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been successfully treated and is considered cured; in the EU/EEA, investigators must document a favorable benefit-risk assessment.
  • History or current status of substance use disorder and or tobacco use disorder. For participants with excessive alcohol intake or currently smoking or using chewing tobacco or with a history of long-term smoking (>=20 pack years) or chewing tobacco use, the investigator must document a favorable benefit-risk assessment to justify the participant's inclusion in the trial.
  • Further exclusion criteria apply.

Trial locations and contacts

45 sites in 8 countries.

45 sites in 8 countries

United States15 sites

  • Arlington Research Center, Inc.

    Arlington, Texas, 76011

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Texas Dermatology Research Center

    Dallas, Texas, 75246

  • Wayne State University

    Detroit, Michigan, 48201

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • First OC Dermatology Research

    Fountain Valley, California, 92708

  • StracSkin, PLLC

    Greenland, New Hampshire, 03840

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Northwell Health Physician Partners

    Lake Success, New York, 11020

  • Apex Clinical Research Center, LLC.

    Mayfield Heights, Ohio, 44124

  • Mount Sinai Doctors

    New York, New York, 10028

  • ODRC Enterprises, LLC dba Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607

Other trials in United States

Canada6 sites

  • CCA Medical Research

    Ajax, Ontario, L1S 7K8

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2

  • Brunswick Dermatology Center

    Fredericton, New Brunswick, E3B 1G9

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

Other trials in Canada

Australia5 sites

  • Skin Health Institute Inc.

    Carlton, Victoria, 3053

  • Skin & Cancer Foundation - The Skin Hospital

    Darlinghurst, New South Wales, 2010

  • Sinclair Dermatology

    Melbourne, Victoria, 3002

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

China5 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Southern Medical Universtiy - Dermatology Hospital (SMUDH) (Guangdong Provincial Dermatology Hospital)

    Guangzhou, Guangdong, 510091

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 31003

  • Huashan Hospital, Fudan University, Shanghai

    Shanghai, Shanghai Municipality, 20040

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)

    Wuhan, Hubei, 430022

Other trials in China

Poland5 sites

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z o.o.

    Malbork, Pomeranian, 82-200

  • Klinika Dermatologii, Uniwersytecki Szpital Kliniczny

    Rzeszów, Podkarpackie, Poland, 35-055

  • Klinika Ambroziak Dermatologia

    Warsaw, Masovia, 02-953

  • PaAstwowy Instytut Medyczny MSWiA

    Warsaw, Mazowsze, 02-507

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak SpAAka Partnerska

    Wroclaw, DolnoAlAskie, 50-566

Other trials in Poland

France4 sites

  • Centre Hospitalier Le Mans

    Le Mans, Sarthe, 72037

  • Hopital Edouard Herriot

    Lyon, Rhone, 69003

  • CHU NICE

    Nice, Alpes Maritimes, 6200

  • CHU de Rouen

    Rouen, 76031

Other trials in France

Germany4 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Charite Dermatology

    Berlin, 10117

  • Katholisches Klinikum Bochum gGmB

    Bochum, Northrhine Westfalia, 44791

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Hautklinik und Poliklinik - Clinical Research Center (CRC)

    Mainz, Rhineland-Palatine, 55131

Other trials in Germany

Netherlands1 site

  • ErasmusMC

    Rotterdam, South Holland, 3015GD

Other trials in Netherlands

About this study

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

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.

Read more

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.

Being tested
Zasocitinib (Dose A), Placebo
Keywords
Drug Therapy
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zasocitinib (Dose A)Drug

    Also called TAK-279, NDI-034858

    Zasocitinib.

  • PlaceboOther

    Placebo.

Study groups in NCT07244263
Study groupRoleWhat they receive
Double-blinded: Zasocitinib (Dose A)ExperimentalParticipants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period.
Receives: Drug: Zasocitinib (Dose A)
Double-blinded: PlaceboPlacebo comparatorParticipants will receive placebo from Day 1 to Week 16 during the double-blind period.
Receives: Other: Placebo
Open-label: Zasocitinib (Dose A)ExperimentalParticipants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period.
Receives: Drug: Zasocitinib (Dose A)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 16

Secondary outcomes (2)

  1. Percentage of Participants who Achieve 50% Reduction in HiSCR50

    HiSCR50 is defined as at least a 50% reduction in the total AN count with no increase in abscess or draining tunnel count relative to baseline.

    Measured: At Week 16

  2. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention.

    Measured: From start of study drug up to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start26 Jan 2026
  3. Primary completion5 Feb 2027 (estimated)
  4. Study completion22 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07244263
Sponsor's protocol ID
TAK-279-HS-2001
Other IDs
2025-522831-33-00, 2025
Status last verified
Nov 2026
First submitted
17 Nov 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zasocitinib (Dose A) in people with Hidradenitis Suppurativa, run by Takeda at 45 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 75 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Canada, Australia, China, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75) (time frame: At Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07244263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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