ISRCTN13127147进行中（未招募）4 期
Treatment of Pustular Psoriasis with the IL-1 receptor antagonist anakinra: a randomised, placebo controlled trial and associated mechanistic studies
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
2018 protocol in https://pubmed.ncbi.nlm.nih.gov/30157880/ (added 05/08/2020) 2020 statistical analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/32041649 (added 12/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 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
- •2. Disease duration of >6 months, not responding to an adequate trial of topical therapy including very potent corticosteroids
- •3. Evidence of active pustulation on palms and /or soles to ensure sufficient baseline disease activity to detect efficacy
- •4. At least moderate disease on the PPP Investigator’s Global Assessment (PPP-IGA)
- •5. Women of child bearing potential who are on adequate contraception, who are not pregnant or breast feeding
- •6. Who have given written, informed consent to participate
排除标准
- •1. Previous treatment with anakinra or other IL-1 antagonists
- •2. A history of recurrent bacterial, fungal or viral infections
- •3. Evidence of active infection or latent TB or who are HIV, Hepatitis B or C sero-positive
- •4. A history of malignancy of any organ system (other than treated, localised non melanoma skin cancer), treated or untreated, within the past 5 years
- •5. Use of therapies with potential or known efficacy in psoriasis during or within the following specified timeframe before treatment initiation (week 0, visit 2):
- •5.1. very potent topical corticosteroids within 2 weeks
- •5.2. 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
- •5.3. methotrexate, ciclosporin, acitretin, alitretinoin within 4 weeks
- •5.4. phototherapy or PUVA within 3 months
- •5.5. etanercept or adalimumab within 4 weeks
- •5.6. infliximab or ustekinumab or secukinumab within 3 months
- •5.7. other TNF antagonists within 3 months
- •5.8. other immunosuppressive or immunomodulatory therapy within 30 days or 5 half lives prior to treatment initiation, whichever is longer
- •5.9. 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
- •6. With moderate renal impairment [CrCl <50ml/min ]
- •7. With neutropenia (<1.5x109/L)
- •8. With known moderate hepatic disease and/or raised hepatic transaminases (ALT/AST) > 2 x ULN at baseline. Patients who fail this screening criterion may still be considered following review by a hepatologist and confirmed expert opinion that study entry is clinically appropriate.
- •9. Live vaccinations within 3 months prior to the start of study medication, during the trial, and up to 3 months following the last dose
- •10. Women who are pregnant, breast feeding or of child bearing age not on adequate contraception or men planning conception
- •11. Poorly controlled diabetes mellitus, cardiovascular disease , asthma, concomitant therapy that may interact with anakinra (for example phenytoin or warfarin) or any condition where, in the opinion of the investigator, anakinra would present risk to the patient
- •12. Latex allergy (inner needle cover of pre-filled syringe contains natural rubber)
- •13. Unable to given written, informed consent.
- •14. Unable to comply with the study visit schedule
研究者
相似试验
进行中（未招募）
1 期
Comparing Anakinra versus placebo in the treatment of pustular psoriasisEUCTR2015-003600-23-GBGuy's and St Thomas NHS Foundation Trust64
进行中（未招募）
3 期
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977PsoriasisNCT04862286AbbVie132
已完成
2 期
A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type PsoriasisPsoriasisNCT01901705China Medical University Hospital24
终止
不适用
An Explorative Psoriasis Biomarker StudyPsoriasis VulgarisNCT04394936Centre for Human Drug Research, Netherlands37
已完成
2 期
Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With PsoriasisPsoriasisNCT00715975Azidus Brasil140