A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe 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

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

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Secukinumab 300 MG; Tofacitinib 11mg

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Jiaqi Chen
      • Contact: Jiaqi Chen, Ph.D., M.D.; Phone Number: +86 15088687593; Email: fatina@zju.edu.cn
      • Contact: Xiaoyong Man, Ph.D., M.D.; Phone Number: +86 13200516219; Email: manxy@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secukinumab treatment group; Participants will take secukinumab 300mg every week in the first month and every four weeks thereafter till 1 year	Drug: Secukinumab 300 MG; Tofacitinib 11mg; Tofacitinib tablet 11mg per tablet; Secukinumab 150mg/ml
Experimental: Tofacitinib treatment group; Participants will take tofacitinib 11mg daily for 1 year	Drug: Secukinumab 300 MG; Tofacitinib 11mg; Tofacitinib tablet 11mg per tablet; Secukinumab 150mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response of HiSCR at week 12 week	abscess and inflammatory nodules with at least a 50% reduction in abscess from baseline, and no increase in drain fistula count relative to baseline	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of adverse events (AE) and serious adverse events (SAE)	Frequency and severity of AE and SAE throughout the study	through study completion, usually 1 year
Clinical response of HiSCR at week 52 week	abscess and inflammatory nodules with at least a 50% reduction in abscess from baseline, and no increase in drain fistula count relative to baseline	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First People's Hospital of Huzhou; First Affiliated Hospital of Wenzhou Medical University; Ningbo No. 1 Hospital; Jinhua Central Hospital; Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Hidradenitis Suppurativa; secukinumab; tofacitinib
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis Suppurativa; Hidradenitis; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: 2024-0358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No