A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 577
- 试验地点
- 718
- 主要终点
- Percentage of Participants with Clinical Remission at Week 48
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
- •Moderately to severely active UC as assessed by the modified Mayo score
- •Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
- •If female and of childbearing potential, must meet the contraception and reproduction requirements
排除标准
- •Has severe extensive colitis as defined in the protocol
- •Extent of inflammatory disease limited to the rectum
- •Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
- •Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
- •Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
研究组 & 干预措施
Group 1: Placebo
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
干预措施: Placebo (Drug)
Group 3: Golimumab
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
干预措施: Golimumab (Biological)
Group 2: Guselkumab
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
干预措施: Guselkumab (Biological)
Group 4: JNJ-78934804 (High-dose)
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
干预措施: JNJ-78934804 (Biological)
Group 5: JNJ-78934804 (Mid-dose)
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
干预措施: JNJ-78934804 (Biological)
Group 6: JNJ-78934804 (Low-dose)
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
干预措施: JNJ-78934804 (Biological)
结局指标
主要结局
Percentage of Participants with Clinical Remission at Week 48
时间窗: Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
次要结局
- Percentage of Participants with Endoscopic Improvement at Week 48(Week 48)
- Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48(Week 48)
- Percentage of Participants with Symptomatic Remission at Week 48(Week 48)
- Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48(Week 48)
- Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48(Week 48)
- Percentage of Participants with Adverse Events (AEs)(Up to Week 48)
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 48)
- Laboratory Parameters Over Time(Up to Week 48)
- Vital Signs Parameters Over Time(Up to Week 48)
- Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score(Up to Week 48)
- Serum Concentrations of Guselkumab Over Time(Up to Week 48)
- Serum Concentrations of Golimumab Over Time(Up to Week 48)
- Percentage of Participants with Antibodies to Guselkumab(Up to Week 48)
- Titers of Antibodies to Guselkumab(Up to Week 48)
- Percentage of Participants with Antibodies to Golimumab(Up to Week 48)
- Titers of Antibodies to Golimumab(Up to Week 48)
- Percentage of Participants with Neutralizing Antibodies to Guselkumab(Up to Week 48)
- Percentage of Participants with Neutralizing Antibodies to Golimumab(Up to Week 48)