Hidradenitis Suppurativa (HS)NCT07109765
Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa (HS), run by Peking Union Medical College at 1 site in China.
Trial summary
This single-center, prospective, observational study aimed to evaluate the efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis suppurativa (HS). The study was conducted from June 1, 2025, to June 1, 2026, and all participants were treated at the Department of Dermatology, Peking Union… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All participants were treated at the Department of Dermatology, Peking Union Medical College Hospital
Who may be able to join
- age ≥18 years
- diagnosis of moderate-to-severe HS with Hurley stage II or III
- Disease duration of ≥6 months, presence of at least one draining tunnel or two inflammatory nodules
- inadequate response to prior treatments, such as antibiotics, isotretinoin, or TNF inhibitors
Who cannot join
- active infections (e.g., viral hepatitis, active tuberculosis)
- use of other biologics or systemic immunosuppressants within the past three months
- severe organ dysfunction (e.g., hepatic or renal failure)
- any other conditions that might affect study results
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
No. 1 Shuai Fu Yuan, Dongcheng District, Beijing
Beijing, Beijing Municipality, 100730
Xiao Ma, 86-18511599355, maxiao9935@163.com
About this study
Official title: Real-World Evaluation of Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa
This single-center, prospective, observational study aimed to evaluate the efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis suppurativa (HS). The study was conducted from June 1, 2025, to June 1, 2026, and all participants were treated at the Department of Dermatology, Peking Union Medical College Hospital. The study was approved by the Clinical and Research Ethics Committee of the Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (Ethics Approval No. I-24PJ1844). All procedures involving human participants adhered to the Declaration of Helsinki. Written informed consent form was signed and obtained from the participant.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Secukinumab
- Keywords
- Hidradenitis Suppurativa, Secukinumab, ultrasound
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
secukinumab 300 mg weekly for five weeks, followed by 300 mg monthly subcutaneous injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
a ≥50% reduction in the combined count of inflammatory nodules and abscesses from baseline, without an increase in the number of abscesses or draining tunnels
Measured: From enrollment to the end of treatment at Week 12
Secondary outcomes (1)
Dermatology Life Quality Index
Measured: From enrollment to the end of treatment at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Ma, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109765
- Sponsor's protocol ID
- No. I-24PJ1844
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation of Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07109765
- Acronym / sponsor ID
- No. I-24PJ1844
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis Suppurativa, Secukinumab, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Aug 2025 (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.
This single-center, prospective, observational study aimed to evaluate the efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis suppurativa (HS). The study was conducted from June 1, 2025, to June 1, 2026, and all participants were treated at the Department of Dermatology, Peking Union Medical College Hospital. The study was approved by the Clinical and Research Ethics Committee of the Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (Ethics Approval No. I-24PJ1844). All procedures involving human participants adhered to the Declaration of Helsinki. Written informed consent form was signed and obtained from the participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All participants were treated at the Department of Dermatology, Peking Union Medical College Hospital
Key inclusion criteria (4 listed)
- age ≥18 years
- diagnosis of moderate-to-severe HS with Hurley stage II or III
- Disease duration of ≥6 months, presence of at least one draining tunnel or two inflammatory nodules
- inadequate response to prior treatments, such as antibiotics, isotretinoin, or TNF inhibitors
Key exclusion criteria (4 listed)
- active infections (e.g., viral hepatitis, active tuberculosis)
- use of other biologics or systemic immunosuppressants within the past three months
- severe organ dysfunction (e.g., hepatic or renal failure)
- any other conditions that might affect study results
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 |
|---|---|---|
| Secukinumabsecukinumab 300 mg weekly for five weeks, followed by 300 mg monthly subcutaneous injection | Drug | – |
Primary outcome
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time frame: From enrollment to the end of treatment at Week 12
a ≥50% reduction in the combined count of inflammatory nodules and abscesses from baseline, without an increase in the number of abscesses or draining tunnels
1 secondary outcome
Dermatology Life Quality Index
Time frame: From enrollment to the end of treatment at week 12
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 7 Aug 2025.
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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?
An observational study of Hidradenitis Suppurativa (HS), run by Peking Union Medical College 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 4 inclusion and 4 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 7 Aug 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) (time frame: From enrollment to the end of treatment at 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 7 Aug 2025.