2025-521590-13-00招募中3 期
A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 112
- 主要终点
- Deep remission at Week 52
研究概览
简要总结
To evaluate the efficacy of guselkumab at Week 52 compared to risankizumab
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has CD or fistulizing CD of at least 12 weeks’ duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy.
- •Have moderately to severely active CD, defined as baseline CDAI score ≥220 but ≤
- •Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening SES-CD ≥4 (for participants with isolated ileal disease) or ≥6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. aminimum score of 1 for the component of “size of ulcers” AND b. a minimum score of 1 for the component of “ulcerated surface”.
- •Demonstrated an inadequate response, loss of response, or intolerance to: At least one ADT AND Limited to 1 or 2 of the following ADT classes that target: a. TNFα (eg, infliximab, adalimumab, certolizumab or biosimilars) b. Integrin (eg, vedolizumab or biosimilars) c. IL-12/23 (eg, ustekinumab or biosimilars) d. JAK (eg, upadacitinib) Note: Participants with an inadequate response, loss of response, or intolerance to ≥3 ADT classes as listed above (in Biologics or oral ADTs section) are excluded from the study. Biologics and advanced oral therapies used to qualify a participant as having had an inadequate response, loss of response, or intolerance must be approved for the treatment of CD in the country/territory of use. Inadequate response is defined as the presence of signs and symptoms of persistently active disease despite a history of completing a dosing regimen based on local labeling. Loss of response is defined as the recurrence of signs and symptoms of active disease during treatment following prior clinical benefit. Intolerance is defined as occurrence of a clinically significant AE on a therapeutic agent that is unresponsive to dose reduction or required discontinuation, and in the judgment of the investigator, precludes use of the therapeutic agent to treat CD.
- •In the opinion of the investigator, participant’s disease is appropriate to treat with the maintenance dosing regimens utilized in the study: guselkumab 200 mg SC q4w or risankizumab 360 mg SC q8w.
排除标准
- •Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgerywithin the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab.
- •Stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 16 weeks before the first dose of study intervention unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Note: Treatment and repeat testing can occur in the current screening period.
- •Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for 12 weeks before the first dose of study intervention or cervical carcinoma in situ that has been treated with no evidence of recurrence for ≥12 weeks before the first dose of study intervention). Note: Premalignant conditions (eg, gastric or esophageal metaplasia) should be discussed with the sponsor for eligibility determination.
- •Known history of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, multiple myeloma or monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease.
- •Meet ANY of the following TB screening criteria: a. Have a history of active TB or show signs or symptoms suggestive of active TB upon medical history and/or physical examination at screening. b. Have a history of untreated latent TB prior to screening. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. c. Have had recent close contact with a person with active TB. An exception is made if such participants are referred to a physician specializing in TB to determine if treatment is warranted or not. This evaluation must be adequately documented and, if treatment is recommended, the participant must be receiving appropriate treatment prior to the first administration of study intervention. d. Have a positive IGRA test result within 5 weeks prior to the first administration of study intervention. An exception is made for participants who: - have a history of adequately treated latent TB described above. - have a newly identified positive IGRA test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated prior to the first administration of study intervention. - have a false-positive IGRA test as determined by the following: o A suspected false-positive initial IGRA test must be repeated. If repeat testing is NOT positive, the participant must be referred to a physician specializing in TB to determine if the initial test can be considered a false-positive. This evaluation must be adequately documented prior to the first administration of study intervention. If repeat testing is positive, however, it will be considered a true-positive and the participant is only eligible if active TB has been ruled out and appropriate treatment for latent TB has been initiated as described above. e. Have a chest radiograph or chest computed tomography within 12 weeks prior to the first administration of study intervention that shows abnormalities suggestive of active or inactive TB.
研究组 & 干预措施
Skyrizi 600 mg concentrate for solution for infusion, Skyrizi 360 mg solution for injection in cartridge
Comparator
干预措施: Skyrizi 600 mg concentrate for solution for infusion (Drug)
Guselkumab
Test
干预措施: Guselkumab (Drug)
Skyrizi 600 mg concentrate for solution for infusion, Skyrizi 360 mg solution for injection in cartridge
Comparator
干预措施: Skyrizi 360 mg solution for injection in cartridge (Drug)
结局指标
主要结局
Deep remission at Week 52
Deep remission at Week 52
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (112)
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