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Tests treatment safety and results for Hidradenitis Suppurativa (HS)
Official title Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07489573
What this study is testing
What is Secukinumab?
Secukinumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hidradenitis suppurativa (hs).
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
- This is a post-approval commitment study to evaluate efficacy, and safety of two dosing regimens of secukinumab (AIN457), 300 mg every four weeks (Q4W) and every two weeks (Q2W), in Chinese adult patients with moderate to severe hidradenitis suppurativa (HS).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent must be obtained before any assessment is performed.
- Chinese male and female participants ≥ 18 years of age.
- Confirmed/documented diagnosis of HS ≥ 6 months prior to baseline.
- Participants with moderate to severe HS at baseline defined as:
- A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND
You likely can't join if
- Total fistulae count ≥ 20 at baseline.
- Any other active skin disease or condition that may interfere with assessment of HS at baseline.
- Active inflammatory bowel disease.
- Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious...
- Use or planned use of systemic biological/non-biological immunomodulator, corticosteroid treatment for HS, or participation in any treatment trial
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A, IL-17 A/F or the IL-17 receptor.
See the full eligibility criteria
- Signed informed consent must be obtained before any assessment is performed.
- Chinese male and female participants ≥ 18 years of age.
- Confirmed/documented diagnosis of HS ≥ 6 months prior to baseline.
- Participants with moderate to severe HS at baseline defined as:
- A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND
- Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)
- Total fistulae count ≥ 20 at baseline.
- Any other active skin disease or condition that may interfere with assessment of HS at baseline.
- Active inflammatory bowel disease.
- Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious including tuberculosis and hepatitis, or gastrointestinal conditions)...
- Use or planned use of systemic biological/non-biological immunomodulator, corticosteroid treatment for HS, or participation in any treatment trial
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A, IL-17 A/F or the IL-17 receptor.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
- Tianjin, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China; Wenzhou, Zhejiang, China; Beijing, China; Shanghai, China; Tianjin, 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.