CTIS2022-501362-22-00进行中（未招募）1 期
22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis - 22104
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 312
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol., No known history of active tuberculosis (TB)., Subject has a negative TB test at screening, as defined by1: o Negative QuantiFERON test OR o Subjects with a positive QuantiFERON test are allowed if all of the following is satisfied: * No symptoms of TB as determined by the investigator. * Documented history of adequate prophylaxis initiation prior to receiving study drug per local guidelines. * No known exposure to a case of active TB after most recent prophylaxis. * No evidence of active TB on chest radiograph within 3 months prior to first dose of study drug. o Subjects with an indeterminate QuantiFERON test are permitted to retest once. If the retest result is indeterminate, subject may be randomized if all of the following is satisfied: * No symptoms of TB as determined by the investigator. * Documented history of adequate prophylaxis initiation prior to receiving study drug per local guidelines. * No known exposure to a case of active TB. If subject has previously received TB prophylaxis, no known exposure to active TB after most recent prophylaxis. * No evidence of active TB on chest radiograph within 3 months prior to first dose of study drug. * Deemed to be low risk per risk determination questionnaire and medical monitor review 1 T-SPOT TB test may be used to establish eligibility if agreed upon with the medical monitor., Male and female subjects: Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male subjects: Male subjects are eligible to participate if they agree to the following during the study drug period and for at least 8 weeks after the last dose of study drug: • Refrain from donating semen, plus either: o Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR o Must agree to use contraception/barrier as detailed below: § Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. b. Female subjects: A female subject is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: • Is a woman of nonchildbearing potential as defined in Section 10.4 (Contraceptive and Barrier Guidance). OR • Is a WOCBP and uses a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 during the study drug period and for at least 8 weeks after the last dose of study drug. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study drug. A WOCBP must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to the first dose of study drug, see Section 8.3.5., Subject must be =18 (or the legal age of consent in the jurisdiction in which the study is taking place) and =75 years of age, at the time of signing the informed consent., Clinical diagnosis of PsA with
排除标准
- •Any history or current confirmed diagnosis of IBD OR Any of the following symptoms (of unknown etiology) or any signs or symptoms within the last year that in the opinion of the Investigator may be suggestive of IBD, with fecal calprotectin > 500 µg/g; OR if fecal calprotectin > 150 to 500 µg/g without confirmed approval from a GI consult that an IBD diagnosis is clinically unlikely (see Section 8.2.11) when the following clinical signs and symptoms are present: a. prolonged or recurrent diarrhea b. prolonged or recurrent abdominal pain c. blood in stool, Known history of human immunodeficiency virus (HIV) or positive HIV test at screening., Positive hepatitis B surface antigen (HBsAg) or detected sensitivity on the hepatitis B virus (HBV) DNA polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBcAb)/hepatitis B surface antibody (HBsAb) positive subjects OR positive hepatitis C virus antibody test at screening., Laboratory abnormalities at screening: a. hemoglobin <9 g/dL b. platelet count <100 000/mm3 c. white blood cell count <3 000 cells/mm3 d. aspartate aminotransferase and/or alanine aminotransferase =2.5 times the upper limit of normal e. estimated glomerular filtration rate <60 mL/min/1.73 m2 at screening f. any other laboratory abnormality that in the opinion of the investigator, will pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Note: Laboratory value(s) out of range due to sampling error or that might be within range after medically appropriate supplementation may be repeated up to 2 times within the screening window before the subject is considered a screen failure., Previous exposure to izokibep or any other IL-17 inhibitor and IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab)., Prior exposure to biologics that had a potential or known association with progressive multifocal leukoencephalopathy (ie, natalizumab [Tysabri], rituximab [Rituxan], or efalizumab [Raptiva])., Exposure to the following within 24 weeks prior to first dose of study drug: a. intramuscular (IM) or oral gold b. cytotoxic agents such as cyclophosphamide, D-penicillamine., Exposure to the following within 12 weeks prior to first dose of study drug: a. TNFi (except etanercept within 4 weeks) b. other experimental or commercially available biologic or biosimilar therapies (within 12 weeks or 5 half-lives, whichever is longer) c. cyclosporine, azathioprine, tacrolimus d. IV gamma-globulin or Prosorba column therapy., Exposure to the following within 4 weeks prior to first dose of study drug: a. janus kinase (JAK) inhibitor (eg, tofacitinib, upadacitinib) b. any other conventional systemic DMARD not covered above (other than methotrexate and hydroxychloroquine unless maintaining on a stable dose through the study as allowed in inclusion criteria) c. IA hyaluronic acid injections d. IA, IM, or IV corticosteroids including adrenocorticotropic hormone e. other psoriasis treatments not listed above (eg, any other biological therapies, mycophenolate mofetil, retinoids, fumarates, or phototherapy [eg, PUVA, UVA, UVB, high potency topical corticosteroids])., Exposure to leflunomide within 8 weeks prior to first dose of study drug (unless maintaining on a stable dose through the study as allowed in inclusion criteria)., Exposure to sulfasalazine and apremilast within 1 week prior to first dose of study drug (unless maintaining a stable dose through the s
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