A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients
Key facts
- Where
- Hangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06707246, who can take part
Where in China
- Jiaqi ChenHangzhou, ChinaContact: Jiaqi Chen, Ph.D., M.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT06707246
- Record updated
- 27 November 2024
- Original description
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:Read full original descriptionShow less
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
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
Inclusion: Patients voluntarily participated in the study and signed informed consent; male and female subjects aged ≥18 years old (when signing the informed consent); Moderate to severe hidradenitis suppurativa: Hurley stage II or III; Patients voluntarily participated in the study and signed informed consent; male and female subjects aged ≥18 years old (when signing the informed consent); Moderate to severe hidradenitis suppurativa: Hurley stage II or III; Participants had stable disease at screening and baseline, with lesions located in ≥2 anatomical areas (≥1 at Hurley stage II/III), a total of ≥3 abscesses and inflammatory nodules (AN), and C-reactive protein levels > 3.0 mg/L; Participants had to have an intolerance, contraindication, or inadequate response to ≥3 months of oral antibiotic treatment for HS or relapse after discontinuation of treatment; Informed consents were signed according to the spirit of the Declaration of Helsinki; agree to receive regular treatment, follow-up, and relevant laboratory examinations in accordance with the clinical research protocol.
Exclusion: patients who had previously used cubitumumab or tofacitinib; Severe infection or systemic infection requiring intravenous anti-infection therapy or hospitalization due to infection within 4 weeks before baseline; Allergy to drugs or excipients; At the time of screening, the medical history, symptoms and examination results of the subjects suggested that the patients had active tuberculosis, active hepatitis B (HBV DNA> lower limit), hepatitis C, syphilis (TPPA+ but excluding active syphilis negative) or AIDS; any active malignant tumor or history of malignant tumor within 5 years, except cured skin squamous cell carcinoma or basal cell carcinoma or cervical cancer in situ; history of drug abuse, attempted suicide or mental illness; other conditions that the investigators thought should not be included; Severe, progressive or uncontrolled liver disease, defined as AST or ALT elevation > 3 times, or total bilirubin ULN elevation >2 times, which can be rescreened after treatment; Baseline drainage tube count > 20, diagnosis of inflammatory diseases other than HS, and history of chronic or recurrent infection or malignant tumor; those who participated in other clinical trials in the past 3 months; pregnant, breastfeeding, or planning to become pregnant during the trial.