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

November 24, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Contact:
          • Xiaoyong Man, Ph.D., M.D.
          • Phone Number: +86 13200516219
          • Email: manxy@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical response of HiSCR at week 12 week
Time Frame: Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of adverse events (AE) and serious adverse events (SAE)
Time Frame: through study completion, usually 1 year
Frequency and severity of AE and SAE throughout the study
through study completion, usually 1 year
Clinical response of HiSCR at week 52 week
Time Frame: 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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