EUCTR2018-002062-39-IT进行中（未招募）1 期
A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa - SUNRISE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 471
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study must meet all of the following criteria:
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female patients >= 18 years of age.
- •3. Diagnosis of HS >= 1 year prior to baseline.
- •4. Patients with moderate to severe HS defined as:
- •- A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules
- •- Inflammatory lesions should affect at least 2 distinct anatomic areas
- •5. Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 447
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Patients meeting any of the following criteria are not eligible for inclusion in this study.
- •1. Total fistulae count >= 20 at baseline.
- •2. Any other active skin disease or condition that may interfere with assessment of HS.
- •3.Active ongoing inflammatory diseases other than HS that require treatment with prohibited
- •medications (see Table 6-2).
- •4. Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic,
- •pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the
- •opinion of the investigator significantly immunocompromises the patient and/or places the
- •patient at unacceptable risk for receiving an immunomodulatory therapy.
- •5. Current severe progressive or uncontrolled diseases which renders the patient unsuitable for
- •the trial or puts the patient at increased risk, including any medical or psychiatric condition
- •which, in the Investigator’s opinion, would preclude the participant from adhering to the
- •protocol or completing the study per protocol.
- •6. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have
- •to be adhered to (see Table 6-2).
- •7. For patients enrolling in the non-antibiotic strata: use of systemic antibiotics for the
- •treatment of HS within 28 days before baseline.
- •For patients enrolling in the antibiotic strata: patients enter the study under concomitant
- •treatment with systemic antibiotics (as per protocol) on a stable dose (defined as a dose or
- •dose regimen that has not changed in the previous 28 days before baseline and is considered
- •unlikely to change at least for the first 16 weeks during the study).
- •8. History of hypersensitivity to any of the study drug constituents.
- •9. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting
- •IL-17 A/F or the IL-17 receptor.
- •10. History of chronic or recurrent systemic infections or active systemic infections during the
- •last two weeks (exception: common cold) prior to randomization.
- •11. Evidence of tuberculosis infection as defined by a positive QuantiFERON® TB-Gold test
- •(QFT) at screening. Patients with a positive or indeterminate QFT test may participate in
- •the study if a full tuberculosis work-up (according to local practice/guidelines) completed
- •within 12 weeks prior to randomization, establishes conclusively that the patient has no
- •evidence of active or latent tuberculosis.
- •12. Medical history record of infection with human immunodeficiency virus (HIV), hepatitis B
- •or C prior to randomization, except for hepatitis C successfully treated and cured.
- •13. History of lymphoproliferative disease or any known malignancy or history of malignancy
- •of any organ system treated or untreated within the past 5 years, regardless of whether there
- •is evidence of local recurrence or metastases (except for skin Bowen’s disease, or basal cell
- •carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the
- •past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that
- •have been removed).
- •14. History or evidence of ongoing alcohol or drug abuse, which in the opinion of the
- •investigator will prevent the patient from adhering to the protocol and completing the study.
- •15. Pregnant or lactating women.
- •16. Women of childbearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using methods of contraception during the entire study
- •or longer if required by locally approved prescribing info
研究者
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