Last Update: Aug 18, 2026 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 ClinicalTrials.gov Identifier: [NCT07489573](https://clinicaltrials.gov/ct2/show/NCT07489573) Novartis Reference Number:CAIN457M2401 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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). 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). Condition Hidradenitis Suppurativa (HS) Phase Phase4 Overall Status Recruiting Number of Participants36 Start Date Jun 01, 2026 Completion Date Nov 05, 2029 Gender All Age(s) 18 Years - (Adult, Older Adult) ## Interventions Drug ### Secukinumab secukinumab 300 mg s.c. administered Q2W or Q4W ## Eligibility Criteria Inclusion 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) Exclusion Criteria: \* 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. China #### Novartis Investigative Site Recruiting Beijing,100730,China #### Novartis Investigative Site Recruiting Hangzhou,Zhejiang,310006,China #### Novartis Investigative Site Recruiting Ningbo,Zhejiang,315016,China #### Novartis Investigative Site Recruiting Wenzhou,Zhejiang,325000,China #### Novartis Investigative Site Recruiting Beijing,100191,China #### Novartis Investigative Site Recruiting Shanghai,200040,China #### Novartis Investigative Site Recruiting Tianjin,300052,China #### Novartis Investigative Site Recruiting Guangzhou,Guangdong,510091,China #### Novartis Investigative Site Recruiting Shijiazhuang,Hebei,050000,China #### Novartis Investigative Site Recruiting Chengdu,Sichuan,610041,China ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ + 1-888-669-6682]() Email: