Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

Phase 4RecruitingNCT07489573

Novartis Pharmaceuticals36 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa (HS)

Interventions

SecukinumabDRUG

secukinumab 300 mg s.c. administered Q2W or Q4W

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Novartis Investigative Site

Guangzhou, Guangdong, China

RECRUITING

Novartis Investigative Site

Shijiazhuang, Hebei, China

RECRUITING

Novartis Investigative Site

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

Percentage change from baseline in AN Count at Week 16

Percent change from baseline in total Abscess and Inflammatory Nodule (AN) count.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Up to Week 52

Percentage of participants achieving NRS30 Skin Pain Response through Week 52

Central Contacts

Novartis Pharmaceuticals

CONTACT

+ 1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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