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Studies

Interventional Recruiting Phase 2

NCT07244263 on ClinicalTrials.gov

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa

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

  • Sponsor: Takeda (Group)
  • Enrollment: 90 (Estimated)
  • Study start: 2026-01-26 (Actual)
  • Primary completion: 2028-02-22 (Estimated)
  • Study completion: 2028-02-22 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Hidradenitis Suppurativa

Intervention / Treatment

  • Drug: Zasocitinib (Dose A)
  • Other: Placebo

Primary Outcome Measures

  • Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75) (At Week 16)
    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.

Countries

Australia, Canada, China, France, Germany, Netherlands, Poland, United States

Locations and Investigators

  • Mayo Clinic, Scottsdale, United States (Not yet recruiting)
    • Site Contact
    • Stella Chen (Principal Investigator)
  • Johnson Dermatology, Fort Smith, United States (Recruiting)
    • Site Contact
    • Sandra Johnson (Principal Investigator)
  • First OC Dermatology Research, Fountain Valley, United States (Recruiting)
    • Site Contact
    • Vivian Laquer (Principal Investigator)
  • Direct Helpers Research Center, Hialeah, United States (Not yet recruiting)
    • Site Contact
    • Frank Don (Principal Investigator)
  • Advanced Clinical Research Institute, Tampa, United States (Recruiting)
    • Site Contact
    • Francis Caban (Principal Investigator)
  • Beth Israel Deaconess Medical Center, Boston, United States (Not yet recruiting)
    • Site Contact
    • Alexa Kimball (Principal Investigator)
  • Wayne State University, Detroit, United States (Not yet recruiting)
    • Site Contact
    • Steven Daveluy (Principal Investigator)
  • Hamzavi Dermatology, Fort Gratiot, United States (Recruiting)
    • Site Contact
    • Fasahat Hamzavi (Principal Investigator)
  • StracSkin, PLLC, Greenland, United States (Recruiting)
    • Site Contact
    • Abel Jarell (Principal Investigator)
  • Northwell Health Physician Partners, Lake Success, United States (Not yet recruiting)
    • Site Contact
    • Amit Garg (Principal Investigator)
  • Mount Sinai Doctors, New York, United States (Not yet recruiting)
    • Site Contact
    • Saakshi Khattri (Principal Investigator)
  • Apex Clinical Research Center, LLC., Mayfield Heights, United States (Not yet recruiting)
    • Site Contact
    • Jorge Garcia-Zuazaga (Principal Investigator)
  • ODRC Enterprises, LLC dba Oregon Dermatology and Research Center, Portland, United States (Not yet recruiting)
    • Site Contact
    • Phoebe Rich (Principal Investigator)
  • Arlington Research Center, Inc., Arlington, United States (Not yet recruiting)
    • Site Contact
    • Angela Moore (Principal Investigator)
  • Texas Dermatology Research Center, Dallas, United States (Not yet recruiting)
    • Site Contact
    • So Yeon Paek (Principal Investigator)
  • Skin & Cancer Foundation - The Skin Hospital, Darlinghurst, Australia (Not yet recruiting)
    • Site Contact
    • John Frew (Principal Investigator)
  • Westmead Hospital, Westmead, Australia (Not yet recruiting)
    • Site Contact
    • Pablo Fernandez Penas (Principal Investigator)
  • Skin Health Institute Inc., Carlton, Australia (Not yet recruiting)
    • Site Contact
    • Peter Foley (Principal Investigator)
  • Sinclair Dermatology, Melbourne, Australia (Not yet recruiting)
    • Site Contact
    • Rodney Sinclair (Principal Investigator)
  • Alfred Hospital, Melbourne, Australia (Not yet recruiting)
    • Site Contact
    • Johannes Kern (Principal Investigator)
  • Beacon Dermatology, Calgary, Canada (Not yet recruiting)
    • Site Contact
    • Susan Poelman (Principal Investigator)
  • Brunswick Dermatology Center, Fredericton, Canada (Not yet recruiting)
    • Site Contact
    • Irina Turchin (Principal Investigator)
  • CCA Medical Research, Ajax, Canada (Not yet recruiting)
    • Site Contact
    • David Adam (Principal Investigator)
  • SimcoDerm Medical and Surgical Dermatology Centre, Barrie, Canada (Recruiting)
    • Site Contact
    • Maryam Shayesteh Alam (Principal Investigator)
  • Ryan Clinical Research Inc., Newmarket, Canada (Withdrawn)
  • SKiN Centre for Dermatology, Peterborough, Canada (Not yet recruiting)
  • Innovaderm Research Inc., Montreal, Canada (Not yet recruiting)
    • Site Contact
    • Etienne Saint-Cyr Proulx (Principal Investigator)
  • DIEX RECHERCHE Quebec, Québec, Canada (Withdrawn)
  • Peking University First Hospital, Beijing, China (Not yet recruiting)
    • Site Contact
    • Li Hang (Principal Investigator)
  • Southern Medical Universtiy - Dermatology Hospital (SMUDH) (Guangdong Provincial Dermatology Hospital), Guangzhou, China (Not yet recruiting)
    • Site Contact
    • Bin Yang (Principal Investigator)
  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST), Wuhan, China (Not yet recruiting)
    • Site Contact
    • Tao Juan (Principal Investigator)
  • Huashan Hospital, Fudan University, Shanghai, Shanghai, China (Not yet recruiting)
    • Site Contact
    • Jinhua Xu (Principal Investigator)
  • The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China (Not yet recruiting)
    • Site Contact
    • Hong Fang (Principal Investigator)
  • CHU NICE, Nice, France (Not yet recruiting)
  • APHM, Marseille, France (Withdrawn)
  • Cabinet medical du Docteur RUER, Martigues, France (Withdrawn)
  • Hopital Edouard Herriot, Lyon, France (Not yet recruiting)
    • Site Contact
    • Axel Villani (Principal Investigator)
  • Centre Hospitalier Le Mans, Le Mans, France (Not yet recruiting)
    • Site Contact
    • Nathalie Beneton (Principal Investigator)
  • CHU de Rouen, Rouen, France (Not yet recruiting)
    • Site Contact
    • Anne Benedicte Duval Modeste (Principal Investigator)
  • Fachklinik Bad Bentheim, Bad Bentheim, Germany (Not yet recruiting)
    • Site Contact
    • Athanasios Tsianakas (Principal Investigator)
  • Katholisches Klinikum Bochum gGmB, Bochum, Germany (Not yet recruiting)
    • Site Contact
    • Falk Bechara (Principal Investigator)
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Hautklinik und Poliklinik - Clinical Research Center (CRC), Mainz, Germany (Not yet recruiting)
    • Site Contact
    • Caroline Mann (Principal Investigator)
  • Charite Dermatology, Berlin, Germany (Not yet recruiting)
    • Site Contact
    • Sonja Molin (Principal Investigator)
  • ErasmusMC, Rotterdam, Netherlands (Not yet recruiting)
    • Site Contact
    • Hessel van der Zee (Principal Investigator)
  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak SpAAka Partnerska, Wroclaw, Poland (Not yet recruiting)
    • Site Contact
    • Jacek Szepietowski (Principal Investigator)
  • Klinika Ambroziak Dermatologia, Warsaw, Poland (Not yet recruiting)
    • Site Contact
    • Justyna Skibinska (Principal Investigator)
  • PaAstwowy Instytut Medyczny MSWiA, Warsaw, Poland (Not yet recruiting)
    • Site Contact
    • Irena Walecka-Herniczek (Principal Investigator)
  • Klinika Dermatologii, Uniwersytecki Szpital Kliniczny, Rzeszów, Poland (Not yet recruiting)
    • Site Contact
    • Adam Reich (Principal Investigator)
  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z o.o., Malbork, Poland (Not yet recruiting)
    • Site Contact
    • Anna Sobieszek-Kundro (Principal Investigator)

Study Officials

  • Study Director (Study Director) — Takeda