EUCTR2016-002492-95-NL进行中（未招募）1 期
A randomized, subject and investigator blinded, placebo controlled, multi-center study in parallel groups to assess the efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •-Male and female subjects aged 18 to 45 years of age included, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening.
- •-Body weight between 50 and 120 kg, inclusive at screening.
- •- Patients with papulo-pustular acne vulgaris with between 25 and 100 facial inflammatory lesions (papules, pustules and nodules), and presence of non-inflammatory lesions (open and closed comedones) in the face at screening and baseline, who have failed systemic therapy for inflammatory acne.
- •-No more than 5 facial inflammatory nodules at screening and baseline.
- •-Investigator's Global assessment (IGA) score of at least moderate (3) acne severity on the face at screening and baseline.
- •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 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of investigational drugs at the time of screening, or within 4 weeks or 5 half-lives of baseline, whichever is longer; or longer if required by local regulations.
- •2.Use of any topical anti-acne prescription treatment within 2 weeks and any over the counter (OTC) anti-acne treatment within 1 week of baseline (use of medicated (anti-acne) creams, medicated cleansers or medicated soaps is prohibited for the duration of the study for Treatment Period 1).
- •3.Use of any oral/systemic treatment for acne, including oral antibiotics, dapsone, oral zinc within 4 weeks prior to baseline.
- •4.Use of systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators (such as cyclosporine, methotrexate, azathioprine, etc.) within 4 weeks before baseline
- •5.Use of any systemic hormonal treatment (in particular anti-androgens, such as spironolactone, finasteride and cyproterone acetate) within 1 month before baseline. Oral contraceptives can be continued if stable for the last 3 months before baseline and if stable in dose and dosing regimen and type (brand) and if the patient plans to continue throughout the study period.
- •6.Previous treatment with biologics (such as anti-TNFa agents or anti-IL-1) within 3 months prior to baseline; Anti-IL-12/23 blocking agents (such as briakinumab and ustekinumab or p19 antibodies) within 6 months prior to baseline.
- •7.Any previous treatment with IL-17 or IL17R blocking agents, including, but not limited to secukinumab, ixekizumab, bimekizumab or brodalumab.
- •8.Use of oral retinoids (in particular isotretinoin) within the last 6 months prior to baseline.
- •9.Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
- •10.Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before baseline.
- •11.Any other forms of acne
- •12.Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
- •13.History of hypersensitivity or allergy to the investigational compound/compound class being used in this study.
- •14.Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
- •15.History of severe systemic Candida infections or evidence of Candidiasis in the 2 weeks prior to baseline.
- •16.Evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of tuberculosis may enter the trial after adequate treatment has been started according to local regulations.
- •17.Patients with known active Crohn’s disease
- •18.History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
- •19.A positive Hepatitis B surface antigen or Hepatitis C test result at screening
- •20.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •21.WOCBP, defined as all women physiologi
研究者
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