Actively Recruiting
A Randomized Clinical 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
52 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
Researchers are evaluating and comparing the effectiveness and safety of two treatments, secukinumab and tofacitinib, in adults with moderate to severe hidradenitis suppurativa (HS). The study aims to find out which treatment works better for this condition and to understand the medical problems participants may experience with each drug. Participants will be adults aged 18 to 75 years with moderate to severe HS, specifically Hurley stage II or III, who have had an inadequate response or intolerance to previous antibiotic treatments. Participants will be randomly assigned to one of two groups. One group will receive secukinumab 300 mg by injection every week for the first month and then every four weeks for up to one year. The other group will take a daily 11 mg tablet of tofacitinib for one year. During the study, participants will visit the clinic every two weeks for the first month and then every four weeks for checkups and tests. Throughout the trial, participants will keep a diary to track their symptoms. Researchers will assess clinical response using the Hidradenitis Suppurativa Clinical Response (HiSCR) at 12 weeks and again at one year. They will also monitor the frequency and severity of any adverse events during the study. Safety and effectiveness will be evaluated over the full one-year treatment period, with regular laboratory tests and follow-up visits to ensure participant well-being.
CONDITIONS
Brief 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 at the time of consent.
- Moderate to severe hidradenitis suppurativa: Hurley stage II or III.
- Stable disease at screening and baseline with lesions in 2 or more anatomical areas (at least 1 at Hurley stage II/III).
- Total of 3 or more abscesses and inflammatory nodules (AN).
- C-reactive protein levels greater than 3.0 mg/L.
- Intolerance, contraindication, or inadequate response to 3 or more months of oral antibiotic treatment for HS or relapse after stopping treatment.
- Agree to receive regular treatment, follow-up, and laboratory examinations according to the research protocol.
You will not qualify if you...
- Allergy to drugs or excipients used in the study.
- Previous use of secukinumab or tofacitinib.
- Active tuberculosis, active hepatitis B, hepatitis C, syphilis (excluding inactive), or AIDS.
- Any active malignant tumor or history of malignant tumor within 5 years, except cured skin squamous cell carcinoma, basal cell carcinoma, or cervical cancer in situ.
- Severe or systemic infection requiring IV treatment or hospitalization within 4 weeks before baseline.
- Severe, progressive, or uncontrolled liver disease (AST or ALT > 3 times normal, or bilirubin > 2 times normal).
- More than 20 baseline drainage tubes, inflammatory diseases other than HS, or history of chronic/recurrent infection or malignant tumor.
- 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 exclusionary by investigators.
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.
Duration - 1 year
Participants receive Secukinumab or Tofacitinib as part of their treatment for moderate to severe hidradenitis suppurativa.
Weekly visits for the first month and then every four weeks for Secukinumab group; daily medication for Tofacitinib group
Trial Site Locations
Total: 1 location
1
Jiaqi Chen
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
J
Jiaqi Chen, Ph.D., M.D.
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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