EUCTR2014-005102-38-CZ进行中（未招募）1 期
BI 655066 / ABBV-066 (risankizumab) versus placebo In a Multicenter randomized double-blind study in patients with Moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with randomized withdrawal and re-treatment (IMMhance) - IMMhance
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 563
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
入选标准
- •1.Male or female patients. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result ina low failure rate of less than 1 percent per year when used consistently and correctly.
- •2.Age 18 = years at screening
- •3.Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
- •4.Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization);
- •Have an involved body surface area (BSA) = 10% and
- •Have a Psoriasis Area and Severity Index (PASI) = 12 and
- •Have a static Physician Global Assessment (sPGA) score of = 3.
- •5.Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
- •6.Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with GCP and local legislation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 425
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1. Patients with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a
- •new onset of psoriasis or an exacerbation of psoriasis from beta
- •blockers, calcium channel blockers, or lithium); active ongoing
- •inflammatory diseases other than psoriasis that might confound trial evaluations according to the investigators judgment
- •2. Previous exposure to BI 655066
- •3. Currently enrolled in another investigational study or less than 30
- •days (from screening) since completing another investigational study.
- •4. Use of any restricted medication as noted in Table 4.2.2.1:1 or any
- •drug considered likely to interfere with the safe conduct of the study
- •5. Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation,).
- •6. Known chronic or relevant acute infections, such as HIV (Human Immunodeficiency Virus), \ viral hepatitis, or tuberculosis.
- •QuantiFERON® TB test or PPD skin test will be performed during
- •screening. Patients with a positive test result may participate in the
- •study if further work up (according to local practice/guidelines)
- •establishes conclusively that the patient has no evidence of active
- •tuberculosis. If presence of latent tuberculosis is estabilished, patients
- •who are at low risk of reactivation, defined by local guidelines and
- •investigator judgement, do not need to be treted with prophylactic anti-tuberculosis prior to or during the trial.
- •7. Any documented active or suspected malignancy or history of
- •malignancy within 5 years prior to screening, except appropriately
- •treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- •8. Evidence of a current or previous disease (including chronic alcohol
- •or drug abuse), medical condition other than psoriasis, surgical
- •procedure (i.e., organ transplant), medical examination finding
- •(including vital signs and ECG), or laboratory value at the screening visit
- •outside the reference range that in the opinion of the Investigator, is
- •clinically significant and would make the study participant unable to
- •adhere to the protocol or to complete the trial, compromise the safety of
- •the patient, or compromise the quality of the data.
- •9. History of allergy/hypersensitivity to a systemically administered
- •biologic agent or its excipients
- •10. Women who are pregnant, nursing, or who plan to become
- •pregnant while in the trial
- •11. Previous enrolment in this trial
研究者
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