Actively Recruiting
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Led by Takeda · Updated on 2026-03-06
90
Participants Needed
49
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow all trial procedures, including use of digital tools
- Provided written informed consent
- Diagnosed with hidradenitis suppurativa for at least 6 months with stable symptoms for 2 months
- HS lesions in at least 2 separate body areas, one at Hurley Stage II or III
- At least 5 inflammatory lesions (abscesses and nodules)
- History of inadequate response or intolerance to oral antibiotics for HS
- Age 18 years or older at consent
- Use of effective contraception if able to become pregnant or assigned male at birth
- In EU/EEA, benefit-risk assessment allowing participation under new JAK inhibitor safety guidelines
You will not qualify if you...
- More than 20 draining tunnels at screening or Day 1
- Other active skin diseases interfering with HS assessment
- Diagnosed with sarcoidosis, lupus, active inflammatory bowel disease, psoriasis, psoriatic arthritis, or rheumatoid arthritis
- History or signs of active or latent tuberculosis without proper treatment
- Active herpes virus infection or serious herpetic infection history
- Positive tests for hepatitis C or B without proper management
- Positive HIV serology
- Recent infections or history of serious infections requiring hospitalization or IV treatment
- History of chronic bacterial or fungal infections
- History of opportunistic infections
- Clinically significant unstable medical conditions or vital sign abnormalities
- Immunodeficiency or unstable autoimmune diseases
- Recent major surgery or planned surgery during the trial
- Uncontrolled hypertension or severe heart failure
- Recent cardiovascular events without investigator approval
- Significant psychiatric illness or suicide risk
- Abnormal lab values or inability to tolerate blood draws
- Known allergies to zasocitinib or its components
- Pregnancy or lactation
- Recent substance abuse
- Recent blood donation over 500 mL or plan to donate during trial
- Employment or dependent relation to trial site staff
- Inability to consent under German radiation protection laws
- History of malignancy within 5 years except certain treated skin or cervical cancers
- History or current tobacco or substance use disorder without favorable assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Actively Recruiting
3
First OC Dermatology Research
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Direct Helpers Research Center
Hialeah, Florida, United States, 33012
Not Yet Recruiting
5
Advanced Clinical Research Institute
Tampa, Florida, United States, 33607
Actively Recruiting
6
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
7
Wayne State University
Detroit, Michigan, United States, 48201
Not Yet Recruiting
8
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Actively Recruiting
9
StracSkin, PLLC
Greenland, New Hampshire, United States, 03840
Actively Recruiting
10
Northwell Health Physician Partners
Lake Success, New York, United States, 11020
Not Yet Recruiting
11
Mount Sinai Doctors
New York, New York, United States, 10028
Not Yet Recruiting
12
Apex Clinical Research Center, LLC.
Mayfield Heights, Ohio, United States, 44124
Not Yet Recruiting
13
ODRC Enterprises, LLC dba Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Not Yet Recruiting
14
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
Not Yet Recruiting
15
Texas Dermatology Research Center
Dallas, Texas, United States, 75246
Not Yet Recruiting
16
Skin & Cancer Foundation - The Skin Hospital
Darlinghurst, New South Wales, Australia, 2010
Not Yet Recruiting
17
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
18
Skin Health Institute Inc.
Carlton, Victoria, Australia, 3053
Not Yet Recruiting
19
Sinclair Dermatology
Melbourne, Victoria, Australia, 3002
Not Yet Recruiting
20
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
21
Beacon Dermatology
Calgary, Alberta, Canada, T3E 0B2
Not Yet Recruiting
22
Brunswick Dermatology Center
Fredericton, New Brunswick, Canada, E3B 1G9
Not Yet Recruiting
23
CCA Medical Research
Ajax, Ontario, Canada, L1S 7K8
Not Yet Recruiting
24
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
25
Ryan Clinical Research Inc.
Newmarket, Ontario, Canada, L3Y 2R2
Withdrawn
26
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
Not Yet Recruiting
27
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2X 2V1
Not Yet Recruiting
28
DIEX RECHERCHE Quebec
Québec, Quebec, Canada, G1V 4T3
Withdrawn
29
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
30
Southern Medical Universtiy - Dermatology Hospital (SMUDH) (Guangdong Provincial Dermatology Hospital)
Guangzhou, Guangdong, China, 510091
Not Yet Recruiting
31
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, China, 430022
Not Yet Recruiting
32
Huashan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, China, 20040
Not Yet Recruiting
33
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China, 31003
Not Yet Recruiting
34
CHU NICE
Nice, Alpes Maritimes, France, 6200
Not Yet Recruiting
35
APHM
Marseille, Bouches Du Rhone, France, 13005
Withdrawn
36
Cabinet medical du Docteur RUER
Martigues, PACA, France, 13.5
Withdrawn
37
Hopital Edouard Herriot
Lyon, Rhone, France, 69003
Not Yet Recruiting
38
Centre Hospitalier Le Mans
Le Mans, Sarthe, France, 72037
Not Yet Recruiting
39
CHU de Rouen
Rouen, France, 76031
Not Yet Recruiting
40
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany, 48455
Not Yet Recruiting
41
Katholisches Klinikum Bochum gGmB
Bochum, Northrhine Westfalia, Germany, 44791
Not Yet Recruiting
42
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Hautklinik und Poliklinik - Clinical Research Center (CRC)
Mainz, Rhineland-Palatine, Germany, 55131
Not Yet Recruiting
43
Charite Dermatology
Berlin, Germany, 10117
Not Yet Recruiting
44
ErasmusMC
Rotterdam, South Holland, Netherlands, 3015GD
Not Yet Recruiting
45
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak SpAAka Partnerska
Wroclaw, DolnoAlAskie, Poland, 50-566
Not Yet Recruiting
46
Klinika Ambroziak Dermatologia
Warsaw, Masovia, Poland, 02-953
Not Yet Recruiting
47
PaAstwowy Instytut Medyczny MSWiA
Warsaw, Mazowsze, Poland, 02-507
Not Yet Recruiting
48
Klinika Dermatologii, Uniwersytecki Szpital Kliniczny
Rzeszów, Podkarpackie, Poland, Poland, 35-055
Not Yet Recruiting
49
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z o.o.
Malbork, Pomeranian, Poland, 82-200
Not Yet Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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