Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis - CNTO1959COR1001

Janssen-Cilag0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Janssen-Cilag
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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 64（—）

入选标准

•Each potential subject must satisfy all of the following criteria to be
•enrolled in the study:
•1. Males and females >=18 years of age.
•2. Diagnosis of phenotypic FAP with disease involvement of the colorectum with
•a. Genetic diagnosis: APC germline mutation (with or without family history) or
•b. Clinical diagnosis: FAP phenotype with >100 adenomas in large intestine
•and subject has a family history of FAP.
•c. Clinical diagnosis: FAP phenotype who are status post colectomy for
•polyposis, subject has a family history of FAP, and 2 FAP experts agree to the
•d. Attenuated FAP diagnosis: APC germline mutation required.
•3. Criterion modified per Amendment 3.
•3.1. Post-colectomy or subtotal colectomy with ileocolonic anastomosis, IRA, or
•4. Polyps with a sum of diameters >=10 mm in the rectum or pouch post screening
•5. Screening laboratory test results within the following parameters (if 1 or
•more of the laboratory parameters is out of range, a single retest of
•laboratory values is permitted during the approximately 4-week screening
•a. White blood cells (WBCs) >=3.5 x 103/µL
•b. Absolute neutrophil count (ANC) >=1.5 x 103/µL
•c. Hemoglobin >= 10.0 g/dL
•d. Platelets >=100 x 103/µL.
•e. Total bilirubin <=1.5 times the upper limit of normal (ULN).
•f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2 times
•g. Creatinine clearance (calculated if measured is not available) >=60
•mL/min/1.73m2
•6. A woman must meet one of the following criteria:
•o premenarchal;
•o postmenopausal (>45 years of age with amenorrhea for at least 12 months or
•any age with amenorrhea for at least 6 months and a serum follicle-stimulating
•hormone [FSH] level >40 IU/L);
•o permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral
•salpingectomy);
•o otherwise incapable of pregnancy;
•o have a negative pregnancy test result at screening and baseline.
•7. Before randomization, a female subject of childbearing potential must be
•practicing a highly effective method of contraception and agrees to remain on a
•highly effective method while receiving study drug and until 12 weeks after
•8. Criterion modified per Amendment 4
•8.1 A woman must agree not to breast feed, or to donate eggs (ova, oocytes) or
•freeze for future use, for the purposes of assisted reproduction during the
•study and for a period of 12 weeks after the last administration of study drug.
•9. Criterion modified per Amendment 4
•9.1 A man must agree not to father a child, or to donate sperm or freeze for
•future use, for the purposes of reproduction during the study and for a period
•of 12 weeks after the last administration of study drug.
•10. Are considered eligible according to the following tuberculosis (TB)
•screening criteria:
•a. Have no history of latent or active TB prior to screening.
•b. Have no signs or symptoms suggestive of active TB upon medical history
•and/or physical examination.
•c. Have had no recent close contact with a person with active TB.
另有 4 项未显示

排除标准

•Any potential subject who meets any of the following criteria will be excluded
•from participating in the study.
•1. Prior use of any biologic therapy targeting IL-12/23, IL-17, or IL-23
•receptor antagonists.
•2. Criterion modified per Amendment 4: Use of non-steroidal anti-inflammatory
•drugs other than aspirin exceeding 5 days per month, unless completes a 4-week
•washout period prior to randomization. The use 100 mg of aspirin a day or 700
•mg of aspirin per week is allowed.
•3. Treatment with other FAP-directed drug therapy, unless completes a 4-week
•washout period prior to randomization.
•Criterion modified per Amendment 3.
•4.1 High grade dysplasia or cancer on biopsy at screening in GI tract
•(including stomach,
•duodenum, and colon/rectum/pouch).
•5. Criterion modified per Amendment 4.
•5.2 Duodenal, colorectal, or pouch polyp:
•>2 cm unless excised at the screening evaluation.
•1 to 2 cm with evidence of high-grade dysplasia upon biopsy unless excised.
•6. Tests positive for hepatitis B virus (HBV) infection or is seropositive for
•antibodies to hepatitis C virus (HCV).
•7. Has a history of, or ongoing, chronic or recurrent infectious disease,
•including but not limited to, chronic renal infection, chronic chest infection,
•recurrent urinary tract infection, or open, draining, or infected skin wounds
•8. Has current signs or symptoms of a clinically significant infection.
•Established non-serious infections need not be considered exclusionary at the
•discretion of the investigator.
•9. Has a history of serious infection, including any infection requiring
•hospitalization or IV antibiotics, for 8 weeks before baseline.
•10. Has evidence of a herpes zoster infection within 8 weeks before baseline.
•11. Has a history of latent or active granulomatous infection, including
•histoplasmosis or coccidioidomycosis. Participants with radiographic evidence
•of possible prior histoplasmosis or coccidioidomycosis will be excluded.
•12. Has a chest x-ray within 12 weeks prior to the first administration of
•study intervention that shows an abnormality suggestive of a malignancy or
•current active infection, including TB.
•13. Has or has had a nontuberculous mycobacterial infection or clinically
•significant opportunistic infection (eg, cytomegalovirus colitis,
•pneumocystosis, invasive aspergillosis).
•14. History of human immunodeficiency virus (HIV) antibody positive, or tests
•positive for HIV.
•15. Any serious underlying medical or psychiatric condition, dementia or
•altered mental status or any issue that would impair the ability of the subject
•to receive or tolerate the planned treatment at the investigational site, to
•understand informed consent or that in the opinion of the investigator would
•contraindicate the subject*s participation in the study or confound the results
•of the study.
•16. History of severe, progressive, or uncontrolled renal, genitourinary,
•hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic,
•neurologic, psychiatric, or metabolic disturbances, or signs and symptoms
•17.Criterion modified per Amendment 4.: Received, or is expected to receive,
另有 3 项未显示

研究者

发起方

Janssen-Cilag

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