A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients
NCT06707246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-11-27
Summary
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
Conditions
Interventions
- DRUG
-
Secukinumab 300 MG; Tofacitinib 11mg
Tofacitinib tablet 11mg per tablet; Secukinumab 150mg/ml
Sponsors & Collaborators
-
First Affiliated Hospital of Wenzhou Medical University
collaborator OTHER -
Jinhua Central Hospital
collaborator OTHER -
Affiliated Hospital of Jiaxing University
collaborator OTHER -
Ningbo No. 1 Hospital
collaborator OTHER -
The First People's Hospital of Huzhou
collaborator OTHER -
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-15
- Primary Completion
- 2026-10-31
- Completion
- 2027-10-31
Countries
- China
Study Locations
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