EUCTR2021-001448-90-DE进行中（未招募）1 期
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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. Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301, and
- •1) completed at least the Week 1 visit of the ANB019-301 study without the use of
- •rescue/prohibited medication for GPP and needed rescue medication starting at Week 1 or
- •later during the ANB019-301 study, or 2) completed the Week 4 visit of the ANB019-301
- •study, and did not need or use rescue/prohibited medication for GPP during his or her entire
- •participation in the ANB019-301 study.
- •NOTE: Subjects who did not need rescue/prohibited medication for GPP during their
- •participation in the ANB019-301 study will not be eligible for this study if they did not
- •complete the Week 4 visit of the ANB019-301 study.
- •2. Subject must be a candidate for prolonged GPP treatment according to the Investigator’s
- •3. Subject has no clinically significant medical condition or physical/laboratory/ECG/vital
- •signs abnormality that would, in the opinion of the Investigator, put the subject at undue risk
- •or interfere with interpretation of study results.
- •4. Contraceptive use by men and women should be consistent with local regulations regarding
- •the methods of contraception for those participating in clinical studies.
- •Contraception and pregnancy:
- •a) A male subject who is sexually active with a female of childbearing potential and has
- •not had a vasectomy must agree to use contraception as detailed in Appendix 1 of this
- •protocol during the treatment period and for at least 220 days (which includes the
- •duration of relevant exposure plus the duration of sperm cycle) after the last study
- •treatment administration and refrain from donating sperm during this period.
- •b) Female subjects:
- •i) A woman of childbearing potential (WOCBP) is eligible to participate if she has a
- •negative urine pregnancy test at Day 1is not breastfeeding, and if
- •heterosexually active agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after receiving the study
- •treatment, and refrains from donating oocytes for assisted reproduction during this
- •period. The female subject’s selected form of contraception must be effective by the
- •time the female subject enters into the study at Day 1 (eg, hormonal contraception
- •should be initiated at least 28 days before Day 1).
- •ii) A woman not of childbearing potential as defined in Appendix 1, must have a
- •follicle-stimulating hormone (FSH) test confirming nonchildbearing potential.
- •Follicle-stimulating hormone testing is not required as part of the present study if
- •already performed in the preceding study (data is available on file) and confirmed
- •nonchildbearing potential.
- •NOTE: If a female participant’s childbearing potential changes after start of the
- •study (eg, a woman who is not heterosexually active becomes heterosexually
- •active, a premenarchal woman experiences menarche), she must begin practicing a
- •highly effective method of birth control, as described above.
- •5. Subject is willing to participate and is capable of giving written informed consent, which
- •must be personally signed and dated by the subject and obtained prior to any study-related
- •activities.
- •6. Subject must be willing to comply with all study procedures and must be available for the
- •duration of the study.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this a
排除标准
- •1. The following drugs or procedures are prohibited between the last visit of the ANB019-301
- •study and the Day 1 visit of the ANB019-302 study (if scheduled on separate days):
- •a) Imsidolimab, or other anti-IL-36R antibody.
- •b) Any topical with active ingredients that could have an effect on GPP (including, but not
- •limited to: corticosteroids, retinoids, vitamin A or D analog preparations, tacrolimus,
- •calcineurin inhibitor, topical H1 and H2 antihistamines, tar preparations, topical
- •antimicrobials, other medicated topical agents).
- •c) Any conventional systemic treatments that could have an effect on GPP (including, but
- •not limited to, corticosteroids [eg, oral, IV, intramuscular], retinoids [eg, acitretin,
- •alitretinoin], methotrexate, cyclosporin, fumaric acid esters, or any other
- •immunosuppressant or immunomodulation drugs).
- •NOTE: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear
- •drops containing corticosteroids are also allowed.
- •d) Any ultraviolet B (UV-B) phototherapy (including tanning beds), excimer laser, or
- •psoralen and ultraviolet A (PUVA) treatment.
- •e) Any nonbiologic investigational drug.
- •f) Marketed or investigational biological agent.
- •g) Live and live-attenuated vaccines.
- •NOTE: Nonlive and nonlive-attenuated vaccines for COVID-19 (eg, ribonucleic acid
- •(RNA)-based vaccines, protein-based vaccines, and nonreplicating viral vector-based
- •vaccines) are allowed during the study.
- •2. Subject has any factor limiting the ability to cooperate and to comply with the study
- •protocol, as determined by the Investigator.
- •3. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant
- •during the study period.
- •4. Subject has any other physical, mental, or medical conditions, which, in the opinion of the
- •Investigator, make study participation inadvisable or could confound study assessments.
- •5. Subject is not able to tolerate IV and/or SC drug administration.
研究者
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