Comparing secukinumab and tofacitinib for treating hidradenitis suppurativa in Chinese patients

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

This study is testing whether secukinumab or tofacitinib works better for treating moderate to severe hidradenitis suppurativa in Chinese adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: cubitumumab, tofacitinib, secukimumab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06707246 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe hidradenitis suppurativa at Hurley stage II or III.

Not a fit: Patients with mild hidradenitis suppurativa or those who have not previously tried oral antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from moderate to severe hidradenitis suppurativa.

How similar studies have performed: Other studies have shown promising results with secukinumab and tofacitinib for similar conditions, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• Jiaqi Chen — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jiaqi Chen, Ph.D., M.D.

Conditions Hidradenitis Suppurativa; secukinumab; tofacitinib