Hidradenitis SuppurativaNCT06707246
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 study testing Secukinumab 300 MG; Tofacitinib 11mg in people with Hidradenitis Suppurativa, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Secukinumab 300 MG; Tofacitinib 11mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiaqi Chen
Hangzhou, Zhejiang, 310009
Jiaqi Chen, Ph.D., M.D., +86 15088687593, fatina@zju.edu.cn
Xiaoyong Man, Ph.D., M.D., +86 13200516219, manxy@zju.edu.cn
About this study
Official title: 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.
Read more
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
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Secukinumab 300 MG; Tofacitinib 11mg
- Keywords
- Hidradenitis Suppurativa; secukinumab; tofacitinib
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 300 MG; Tofacitinib 11mgDrug
Tofacitinib tablet 11mg per tablet; Secukinumab 150mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab treatment group | Experimental | Participants will take secukinumab 300mg every week in the first month and every four weeks thereafter till 1 year Receives: Drug: Secukinumab 300 MG; Tofacitinib 11mg |
| Tofacitinib treatment group | Experimental | Participants will take tofacitinib 11mg daily for 1 year Receives: Drug: Secukinumab 300 MG; Tofacitinib 11mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (2)
Frequency and severity of adverse events (AE) and serious adverse events (SAE)
Frequency and severity of AE and SAE throughout the study
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Jinhua Central Hospital, Affiliated Hospital of Jiaxing University, Ningbo No. 1 Hospital, The First People's Hospital of Huzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707246
- Sponsor's protocol ID
- 2024-0358
- Status last verified
- Oct 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06707246
- Acronym / sponsor ID
- 2024-0358
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa; secukinumab; tofacitinib
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Jinhua Central Hospital, Affiliated Hospital of Jiaxing University, Ningbo No. 1 Hospital, The First People's Hospital of Huzhou
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secukinumab treatment group | Experimental | Drug: Secukinumab 300 MG; Tofacitinib 11mgParticipants will take secukinumab 300mg every week in the first month and every four weeks thereafter till 1 year |
| Tofacitinib treatment group | Experimental | Drug: Secukinumab 300 MG; Tofacitinib 11mgParticipants will take tofacitinib 11mg daily for 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab 300 MG; Tofacitinib 11mgTofacitinib tablet 11mg per tablet; Secukinumab 150mg/ml | Drug | Secukinumab treatment group, Tofacitinib treatment group |
Primary outcome
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
2 secondary outcomes
Frequency and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: through study completion, usually 1 year
Clinical response of HiSCR at week 52 week
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secukinumab 300 MG; Tofacitinib 11mg in people with Hidradenitis Suppurativa, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaqi Chen, Ph.D., M.D. (+86 15088687593, fatina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response of HiSCR at week 12 week (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.