Trial comparing treatments for Hidradenitis Suppurativa
Official title A Randomized 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
What this study is testing
What is Secukinumab 300 MG; Tofacitinib 11mg?
Secukinumab 300 MG; Tofacitinib 11mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients voluntarily participated in the study and signed informed consent.
- male and female people 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 people aged ≥18 years old (when signing the informed consent);
You likely can't join if
- 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 people suggested that the patients had active tuberculosis...
- any active malignant tumor or history of malignant tumor within 5 years, except cured skin squamous cell carcinoma or basal cell carcinoma or...
- Severe infection or systemic infection requiring intravenous anti-infection therapy or hospitalization due to infection within 4 weeks before...
- Severe, progressive or uncontrolled liver disease, defined as AST or ALT elevation \> 3 times, or total bilirubin ULN elevation \>2 times, which can...
See the full eligibility criteria
- Patients voluntarily participated in the study and signed informed consent.
- male and female people 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 people 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 \>...
- 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.
- 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 people suggested that the patients had active tuberculosis, active hepatitis B (HBV DNA\> lower limit), hepatitis C, syphilis (TPPA+...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.