EUCTR2020-000489-40-GB进行中（未招募）1 期
A Multi-Centre, Randomised, Open-Label, Phase IIb Study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin Associated Periodic Syndromes
Inflazome (Australia) Pty Ltd.0 个研究点目标入组 14 人开始时间: 2020年4月3日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
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
- •1.Participants must be willing and able to provide written informed consent as described in Section 10.1, Appendix 1 (includes compliance with the requirements and restrictions listed in the ICF and in this protocol) after the nature of the study has been explained and prior to the commencement of any study procedures.
- •2.Male or female adult participants with a confirmed diagnosis of CAPS aged between 18 to 75 years (inclusive at the time of signing the informed consent).
- •A confirmed diagnosis of CAPS comprises the following:
- •a.Documented verification of a genetic mutation in NLRP3; and
- •b.Participant has previously experienced at least 2 typical clinical symptoms of CAPS (may include urticarial skin rash, myalgia, arthralgia, recurrent fever, fatigue/malaise, headache, conjunctivitis, and any other autoinflammatory symptom usual for a given participant); and
- •c.Participant previously had elevated levels of CRP or SAA (> 2 × ULN).
- •3.Positive response to IZD174 in ex vivo whole blood lipopolysaccharide (LPS)+Nigericin induced IL-1ß release (IC50 < 50 µM).
- •4.Participants must be willing to discontinue current anti-IL-1 inhibitor treatment prior to dosing if applicable.
- •5.Participants must demonstrate flaring of CAPS following discontinuation of anti-IL-1 inhibitor treatment or if newly diagnosed. Flaring is defined as IGA score specific at the time of consultation > 5 with an elevation of CRP (> 2 × ULN).
- •6.Participants must have a body mass index (BMI) between =18.0 and =38.0 kg/m2 at Screening.
- •7.Female participants of reproductive age must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception as detailed in Section 10.4, Appendix 4 from Screening until 1 month after the last treatment day. Double contraception is defined as a condom and one other form of the following:
- •-A vaginal ring or an intrauterine device (IUD).
- •-Documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner).
- •Women not of childbearing potential must be post menopausal for = 12 months. Post menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels = 40 IU/mL at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
- •True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception].
- •Participant complete abstinence for the duration of the study and for 1 month after the last study treatment is acceptable.
- •Female participants who are in same sex relationships are not required to use contraception.
- •Male participants must be abstinent, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the participant and his partner must be using an acceptable, highly effective double contraceptive method as detailed in Section 10.4, Appendix 4 from Screening until Follow up Visit.
- •Participants with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred
排除标准
- •1.Use of any investigational drug or investigational device or investigational medical device or participation in a clinical study within 4 weeks prior to Screening or 5 half lives of the product (whichever is longer).
- •2.Live vaccinations within 3 months prior to Screening, for the duration of the study and for up to 3 months following the last dose of study drug.
- •3.Positive QuantiFERON test at the Screening Visit or within 2 months prior to Screening. Participants who have a positive QuantiFERON test with documentation of Bacillus of Calmette and Guerin vaccination, who are at low environmental risk for tuberculosis infection or reactivation and have a negative chest X-ray can be included.
- •4.Any severe, progressive, or uncontrolled medical condition at Baseline that in the judgment of the Investigator prevents the participant from participating in the study.
- •5.Prior or ongoing medical history, physical findings, or laboratory abnormality at Screening that, in the Investigator’s (or delegate’s) opinion, may affect full participation or compliance with the protocol, or could adversely affect the safety of the participant.
- •6.Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will complete the study per protocol.
- •7.Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- •8.Plasma donation within 7 days prior to the first study drug administration.
- •9.Active systemic infections (other than common cold) within 2 weeks prior to Baseline.
- •10.History of severe allergic or anaphylactic reactions.
- •11.History of (or) is currently immunocompromised.
- •12.Abnormal laboratory tests at Screening that are considered by the Investigator to be clinically significant.
- •13.Alkaline phosphatase (ALP), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 × ULN at Screening. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate.
- •14.Positive test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibody at Screening.
- •15.Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, benzodiazepines, opiates and cocaine.
- •16.Participants with a history of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration).
- •17.Use of any prescription drugs, over-the-counter (OTC) medication, herbal remedies, supplements or vitamins 1 week prior to dosing. 1 2 therapeutic doses per week of simple analgesia (aspirin, paracetamol, and other nonsteroidal anti-inflammatory drug [NSAID]) may be permitted at the discretion of the Investigator.
- •18.Inability or unwillingness to undergo repeated visits and venepunctures (e.g., due to poor tolerability or lack of access to veins).
- •19.Participant is unwilling to refrain from strenuous exercise from 2 days prior to Baseline until the Follow-up Visit.
- •20.Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
研究者
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