Actively Recruiting
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
90
Participants Needed
49
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 16 weeks
Participants receive either zasocitinib or placebo during the double-blind period to assess efficacy and safety.
Visits occur throughout the 16-week treatment period
Duration - 36 weeks
Participants receive open-label zasocitinib from Week 16 to Week 52.
Visits occur during the open-label treatment period
Duration - Up to 4 weeks after treatment ends
Participants are monitored for safety and treatment emergent adverse events up to Week 56.
Follow-up visits for safety monitoring
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
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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