2025-523259-72-00招募中3 期
A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 313
- 试验地点
- 107
- 主要终点
- Occurrence of treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe HS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained before any assessment is performed.
- •Ability to communicate effectively with the Investigator, to understand and willing to comply with the requirements of the study
- •Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
- •Participant does not meet any treatment discontinuation criteria of the core study at Week 68
排除标准
- •Ongoing or planned use of prohibited HS or non-HS treatments
- •Participants not expected to benefit from participation in the extension study, or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
- •Current severe progressive or uncontrolled disease which in the judgment of the Investigator renders the participant unsuitable for the study
- •Pregnant or lactating women or female participants who are planning to become pregnant during the study or within 4 weeks following the final dose of study treatment
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 7 days after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
研究组 & 干预措施
Placebo to Remibrutinib (LOU064) XX mg film-coated tablet, Placebo to Remibrutinib (LOU064) XX mg film-coated tablet
Placebo
干预措施: Placebo to Remibrutinib (LOU064) XX mg film-coated tablet (Drug)
LOU064, LOU064
Test
干预措施: LOU064 (Drug)
结局指标
主要结局
Occurrence of treatment-emergent Adverse Events (TEAEs)
Occurrence of treatment-emergent Adverse Events (TEAEs)
次要结局
- • Achievement of AN50/75/90. • Percentage change from baseline in IHS4 • Achievement of HiSCR50/75/90. • Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the main studies).
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (107)
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