EUCTR2015-003600-23-GB进行中（未招募）1 期
Treatment of Pustular Psoriasis with the IL-1 receptor antagonist anakinra: a randomised, placebo controlled trial and associated mechanistic studies
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
- •Inclusion criteria for the for the double-blind treatment stage, placebo controlled study.
- •i. Adults (18 years and over) with diagnosis of Palmo-Plantar Pustulosis (PPP) made by a trained dermatologist with disease of sufficient impact and severity to require systemic therapy
- •ii. Disease duration of >6 months, not responding to an adequate trial of topical therapy including very potent corticosteroids
- •iii. Evidence of active pustulation on palms and /or soles to ensure sufficient baseline disease activity to detect efficacy
- •iv. At least moderate disease on the PPP Investigator’s Global Assessment (PPP-IGA)
- •v. Women of child bearing potential who are on adequate contraception (see Appendix A , contraception guidelines), who are not pregnant or not breast feeding
- •vi. Who have given written, informed consent to participate
- •Inclusion Criteria for the Open Label Extension
- •i. Participation in the double-blind placebo controlled study.
- •ii. Completion past Visit 4 (Week 8) of the double-blind placebo controlled study.
- •iii. Women of child bearing potential who are on adequate contraception (see Appendix A), contraception guidelines), who are not pregnant or not breast feeding
- •iv. Who have given written, informed consent to participate
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •Double-blind stage
- •i. Previous treatment with anakinra or other IL-1 antagonists
- •ii. A history of recurrent bacterial, fungal or viral infections which, in the opinion of the principal investigator, present a risk to the patient
- •iii. Evidence of active infection or latent TB or who are HIV, Hepatitis B or C sero-positive
- •iv. A history of malignancy of any organ system (other than treated, localised non melanoma skin cancer), treated or untreated, within the past 5 years
- •v. Use of therapies with potential or known efficacy in psoriasis during or within the following specified timeframe before treatment initiation (week 0, visit 2):
- •a. very potent topical corticosteroids within 2 weeks b. topical treatment that is likely to impact signs and symptoms of psoriasis (e.g. corticosteroids, vitamin D analogues, calcineurin inhibitors, retinoids, keratolytics, tar, urea) within 2 weeks c. methotrexate, ciclosporin, acitretin, alitretinoin within 4 weeks d. phototherapy or PUVA within 4 weeks e. etanercept or adalimumab within 4 weeks f. infliximab or ustekinumab or secukinumab within 3 months g. other TNF antagonists within 3 months h. other immunosuppressive or immunomodulatory therapy within 30 days or 5 half lives prior to treatment initiation, whichever is longer
- •i. any other investigational drugs within 30 days(or 3 months for investigational monoclonal antibodies)or 5 half-lives prior to treatment initiation, whichever is longer
- •vi. With moderate renal impairment[CrCl<50ml/min]
- •vii. With neutropenia(<1.5x109/L)
- •viii. With thrombocytopenia(<150x109/L)
- •ix. With known moderate hepatic disease &/or raised hepatic transaminases (ALT/AST) >2xULN at baseline. Patients who fail this criterion may still be considered following review by a hepatologist&confirmed expert opinion that study entry is clinically appropriate.
- •x. Live vaccinations within 3 months prior to the start of study medication, during the trial, & up to 3 months following the last dose
- •xi. Women who are pregnant, breastfeeding or of child bearing age not on adequate contraception or men planning conception
- •xii. Poorly controlled diabetes mellitus, cardiovascular disease, asthma, concomitant therapy that may interact with anakinra(eg phenytoin or warfarin)or any condition where, in the opinion of the investigator, anakinra would present risk to the patient.
- •xiii. Unable to given written, informed consent.
- •xiv. Unable to comply with the study visit schedule
- •xv.Diagnosis(or historic diagnosis)of either childhood or adult onset Still’s disease.
- •Open Label Extension
- •i. A history of recurrent bacterial, fungal or viral infections which, in the opinion of the principal investigator, present a risk to the patient
- •ii.Evidence of active infection or latent TB or who are HIV, Hepatitis B or C sero-positive(only required for patients who are beyond Visit 5 the double-blind treatment stage, placebo controlled study).
- •iii.A history of malignancy of any organ system(other than treated, localised non-melanoma skin cancer),treated or untreated, within the past 5 years
- •iv.Use of therapies with potential or known efficacy in psoriasis during or within the following specified timeframe before treatment initiation (Visit OLE 1):
- •a. methotrexate, ciclosporin, acitretin, alitretinoin within 4 weeks b. phototherapy or PUVA within 4 weeks c. etanercept or adalimumab within 4 weeks d. infliximab or ustekinumab or secukinumab within 3 months e. other TNF antagonists within 3 months f. other immunosuppres
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