A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06707246
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to compare the efficacy secukimumab versus tofacitinib in patients with moderate to severe hidradenitis suppurativa (HS)in adults. It will also learn about the safety of secukimumab and tofacitinib. The main questions it aims to answer are: * Which treatment is more effective in patients with moderate to severe HS? * What medical problems do participants have when taking secukimumab versus tofacitinib? Researchers will compare secukimumab versus tofacitinib to see which treatment works better to treat moderate to severe HS. Participants will: * Half of participants will take secukimumab every week in the first month and every four weeks thereafter till 1 year * Another half of participants will take tofacitinib a tablet daily for 1 year * Visit the clinic once every 2 weeks for checkups and tests in the first month, and every 4 weeks thereafter * Keep a diary of their symptoms and the number of times they use a rescue inhaler

Key Dates

Start date
Dec 15, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab treatment group
    Participants will take secukinumab 300mg every week in the first month and every four weeks thereafter till 1 year
  • Experimental: Tofacitinib treatment group
    Participants will take tofacitinib 11mg daily for 1 year

Primary Outcome Measure

Clinical response of HiSCR at week 12 week [ Time Frame: Week 12 ]

Central Contacts

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