Actively Recruiting
A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-11-27
60
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
F
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participated in the study and signed informed consent.
- Male and female subjects aged 18 years or older.
- Moderate to severe hidradenitis suppurativa: Hurley stage II or III.
- Stable disease at screening and baseline with lesions in two or more anatomical areas (at least one at Hurley stage II or III).
- At least three abscesses and inflammatory nodules in total.
- C-reactive protein levels greater than 3.0 mg/L.
- Intolerance, contraindication, or inadequate response to at least three months of oral antibiotic treatment for HS or relapse after stopping treatment.
- Agreement to receive regular treatment, follow-up, and laboratory examinations according to the study protocol.
- Informed consent signed according to the Declaration of Helsinki.
You will not qualify if you...
- Allergy to study drugs or their ingredients.
- Previous use of secukinumab or tofacitinib.
- Active tuberculosis, active hepatitis B or C, syphilis (excluding treated cases), or AIDS at screening.
- Any active cancer or history of cancer within the past 5 years, except certain treated skin or cervical cancers.
- Severe or systemic infections requiring intravenous treatment or hospitalization in the 4 weeks before baseline.
- Severe, progressive, or uncontrolled liver disease with specific lab abnormalities.
- More than 20 drainage tubes at baseline, inflammatory diseases other than HS, chronic or recurrent infections, or cancer history.
- History of drug abuse, suicide attempts, or mental illness.
- Participation in other clinical trials within the past 3 months.
- Pregnant, breastfeeding, or planning pregnancy during the trial.
- Other conditions deemed unsuitable by investigators.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiaqi Chen
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
J
Jiaqi Chen, Ph.D., M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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