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

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Препарат Secukinumab
  secukinumab 300 mg s.c. administered Q2W or Q4W

Первичные конечные точки

• Percentage of participants achieving HiSCR50 at Week 16 [Срок оценки: Week 16]

Вторичные конечные точки (8)

• Percentage change from baseline in AN Count at Week 16 [Срок оценки: Week 16]
• Percentage of participants experiencing an HS Flare through Week 16 [Срок оценки: Up to Week 16]
• Percentage of participants achieving NRS30 Skin Pain Response at Week 16 [Срок оценки: Week 16]
• Percentage of participants achieving HiSCR50 through Week 52 [Срок оценки: Up to Week 52]
• Percentage of participants experiencing HS Flares through Week 52 [Срок оценки: Up to Week 52]
• Percentage of participants achieving NRS30 Skin Pain Response through Week 52 [Срок оценки: Up to Week 52]
• Change from baseline in AN Count through Week 52 [Срок оценки: Up to Week 52]
• Number of participants with Adverse Events through Week 52 [Срок оценки: Up to Week 52]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Novartis Investigative Site — Ханчжоу
• Novartis Investigative Site — Ningbo
• Novartis Investigative Site — Wenzhou
• Novartis Investigative Site — Пекин
• Novartis Investigative Site — Пекин
• Novartis Investigative Site — Шанхай
• Novartis Investigative Site — Тяньцзинь

Идентификаторы

NCT: NCT07489573 · CAIN457M2401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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