Hidradenitis Suppurativa (HS)Phase 4NCT07489573
Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
A Phase 4 study testing Secukinumab in people with Hidradenitis Suppurativa (HS), run by Novartis Pharmaceuticals at 10 sites in China.
Trial summary
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). 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 10 sitesChina
- Study dates
- 1 Jun 2026to 5 Nov 2029
- Phase
- Phase 4
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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), which in the opinion of the investigator, significantly immunocompromise the participant and/or place the participant at unacceptable risk for receiving an immunomodulatory therapy.
- Use or planned use of systemic biological/non-biological immunomodulator, corticosteroid treatment for HS, or participation in any interventional 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100191
- Recruiting
Novartis Investigative Site
Beijing, 100730
- Recruiting
Novartis Investigative Site
Chengdu, Sichuan, 610041
- Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, 510091
- Recruiting
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
- Recruiting
Novartis Investigative Site
Ningbo, Zhejiang, 315016
- Recruiting
Novartis Investigative Site
Shanghai, 200040
- Recruiting
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
- Recruiting
Novartis Investigative Site
Tianjin, 300052
- Recruiting
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
About this study
Official title: An Open-label, Multicenter Study Assessing Efficacy and Safety of Secukinumab up to One Year in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
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).
Read the detailed description
The study consists of a Screening period (at least 7 days and up to 4 weeks), Treatment Period 1 (16 weeks), Treatment Period 2 (36 weeks), and a post-treatment Follow-up period (10 or 12 weeks depending on dose regimens). Total duration of the study is up to 66 weeks.
Screening period: A screening period of at least 7 days and up to 4 weeks will be used to assess the participant´s eligibility, to complete 7-day Pain NRS and to washout and/or taper prohibited medication(s).
Treatment Period 1: All participants will be administered subcutaneous (s.c.) injections of secukinumab 300 mg once a week for five weeks (induction) at Baseline, Weeks 1, 2, 3 and 4. Thereafter, the frequency of study drug injections will be every 4 weeks for all participants up to Week 16.
Treatment Period 2: Starting from Week 16, participants can continue secukinumab 300 mg Q4W dosing until Week 48 or switch to secukinumab 300 mg Q2W, until Week 50 based on investigator's judgement at Week 16.
Follow-up period: Participants who prematurely discontinue study treatment in Treatment Periods 1 or 2 for any reason will enter the Post-Treatment Follow-Up period and complete the EOS visit (12 weeks after the last administration of study treatment).
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Secukinumab
- Keywords
- Moderate to severe hidradenitis suppurativa (HS), IL-17A, monoclonal antibody, AIN457, secukinumab, HiSCR, pain, efficacy, safety
- Medical subject headings
- Hidradenitis Suppurativa, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
secukinumab 300 mg s.c. administered Q2W or Q4W
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab Q2W | Experimental | Participants receive secukinumab administered every two weeks (Q2W) at the specified dose Receives: Drug: Secukinumab |
| Secukinumab Q4W | Experimental | Participants receive secukinumab administered every four weeks (Q4W) at the specified dose Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving HiSCR50 at Week 16
HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.
Measured: Week 16
Secondary outcomes (8)
Percentage change from baseline in AN Count at Week 16
Percent change from baseline in total Abscess and Inflammatory Nodule (AN) count.
Measured: Week 16
Percentage of participants experiencing an HS Flare through Week 16
Flare is defined as at least a 25% increase in AN count from baseline with a minimum absolute increase of 2 lesions.
Measured: Up to Week 16
Percentage of participants achieving NRS30 Skin Pain Response at Week 16
Among participants with baseline NRS ≥3, NRS30 is defined as ≥30% reduction and ≥2-unit reduction from baseline in Patient's Global Assessment of Skin Pain (worst level).
Measured: Week 16
Percentage of participants achieving HiSCR50 through Week 52
Proportion of participants achieving HiSCR50 (≥50% reduction in AN count with no worsening of abscesses or draining fistulae) with secukinumab 300 mg Q2W or Q4W.
Measured: Up to Week 52
Percentage of participants experiencing HS Flares through Week 52
Flare defined as ≥25% increase from baseline in AN count with a minimum increase of 2 lesions.
Measured: Up to Week 52
Percentage of participants achieving NRS30 Skin Pain Response through Week 52
Proportion of participants achieving NRS30 (≥30% and ≥2-unit reduction in skin pain intensity).
Measured: Up to Week 52
Change from baseline in AN Count through Week 52
Absolute and percentage change in AN count relative to baseline.
Measured: Up to Week 52
Number of participants with Adverse Events through Week 52
Number of participants with safety and tolerability assessments
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jun 2026
- Primary completion25 Sep 2029 (estimated)
- Study completion5 Nov 2029 (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.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489573
- Sponsor's protocol ID
- CAIN457M2401
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com