Clinical Trials List
2026-06-15 - 2030-04-16
Phase III
Not yet recruiting4
A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
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Trial Applicant
Johnson & Johnson
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/08
Investigators and Locations
Co-Principal Investigator
- Puo-Hsien Le 無
- 許振銘 無
- Chia-Jung Kuo 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
預充填式注射劑
Active Ingredient
JNJ-78934804 (Guselkumab/Golimumab Combination)
Dosage Form
230
Dosage
JNJ-78934804(Guselkumab /Golimumab; 160 mg/ 80mg; 1.6ml)
Endpoints
臨床緩解定義為克隆氏症活性指數 (CDAI) 分數低於 (＜) 150。CDAI 分數範圍為 0 至約 600。分數越高表示疾病活性越高。
[時間範圍：第 48 週]
2.共同主要：第 48 週達到內視鏡緩解的參與者百分比
內視鏡緩解定義為簡易克隆氏症內視鏡分數 (SES-CD) 分數小於或等於 (≤) 4，且較基準期的值降低至少 2 分，且任何個別項目的子分數均不大於 (＞) 1。
SES-CD 是以 4 個內視鏡項目（潰瘍的存在／大小、潰瘍覆蓋的黏膜表面比例、受任何病灶影響的黏膜表面比例，以及縮窄／狹窄的存在／類型）在 5 個迴腸結腸節段中的評估為依據。SES-CD 分數範圍為 0 至 56。分數越高表示疾病越嚴重。
[時間範圍：第 48 週]
Inclution Criteria
Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
Exclusion Criteria
Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
Presence of draining (that is, functioning) stoma or ostomy
Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
Currently has or is suspected of having an abscess
The Estimated Number of Participants
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Taiwan
7 participants
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Global
460 participants
