Comparing secukinumab and tofacitinib for treating hidradenitis suppurativa in Chinese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the efficacy and safety of two treatments, secukinumab and tofacitinib, in adults with moderate to severe hidradenitis suppurativa. Participants will be randomly assigned to receive either secukinumab injections or tofacitinib tablets for one year, with regular clinic visits for monitoring. The study will evaluate which treatment is more effective and assess any medical problems associated with each medication. Participants will also maintain a diary to track their symptoms and medication use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Allergy to drugs or excipients;
* patients who had previously used cubitumumab or tofacitinib;
* 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;
* Severe infection or systemic infection requiring intravenous anti-infection therapy or hospitalization due to infection within 4 weeks before baseline;
* 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;
* history of drug abuse, attempted suicide or mental illness;
* those who participated in other clinical trials in the past 3 months;
* pregnant, breastfeeding, or planning to become pregnant during the trial;
* other conditions that the investigators thought should not be included.

Where it's running

• Jiaqi Chen
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jiaqi Chen, Ph.D., M.D.
• Email: fatina@zju.edu.cn
• Phone: +86 15088687593

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.