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Clinical Trials List

Protocol NumberCNTO1959CRD3001

NCT Number(ClinicalTrials.gov Identfier)NCT03466411

Active

2018-06-01 - 2027-06-30

Phase II/III

Recruiting4

ICD-10K50

Crohn's disease [regional enteritis]

ICD-9555.0

Regional enteritis, small intestine

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Trial Applicant

PAREXEL INTERNATIONAL CO., LTD.
Sponsor

PAREXEL
Trial scale

Multi-Regional Multi-Center
Update

2026/10/13

Investigators and Locations

Principal Investigator

National Taiwan University Hospital

Co-Principal Investigator

翁昭旼 Digestive System Department
謝銘鈞 Digestive System Department
YEN-HSUAN NI Division of Pediatrics
SHU-CHEN WEI Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Hwei-Ming Wang Division of General Surgery

China Medical University Hospital

Co-Principal Investigator

陳奕彰 Division of General Surgery
陳宏彰 Division of General Surgery
張伸吉 Division of General Surgery
Tao-Wei Ke Division of General Surgery
蔡元耀 Division of General Surgery
謝明皓 Division of General Surgery
Tzu-Liang Chen Division of General Surgery
黃郁純 Division of General Surgery

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 顏旭亨 Digestive System Department

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

徐友春 Digestive System Department
張譽耀 Division of Colorectal Surgery

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Tang Chiu

Linkou Chang Gung Medical Foundation

Taiwan National PI

邱正堂

Co-Principal Investigator

許振銘 Digestive System Department
林偉彬 Digestive System Department
Chia-Jung Kuo Digestive System Department
Cheng-Yu Lin Digestive System Department
Puo-Hsien Le Digestive System Department
Ming-Yao Su Digestive System Department
Puo-Hsien Le Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Moderately to Severely Active Crohn′s Disease

Objectives

Primary Objectives  To evaluate the clinical efficacy of guselkumab in participants with Crohn’s disease  To evaluate the safety of guselkumab  Secondary Objectives  To evaluate the dose-response of guselkumab to inform dose selection for the Phase 3 portion of this protocol  To evaluate the efficacy of guselkumab on endoscopic improvement  To evaluate the pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of guselkumab therapy, including changes in C-reactive protein (CRP) and fecal calprotectin  Other Objectives  To evaluate the impact of guselkumab on health-related quality of life (HRQOL) and health economics outcome measures  To evaluate the efficacy of guselkumab on histologic improvement

Test Drug

guselkumab、ustekinumba

Active Ingredient

guselkumab
ustekinumab
ustekinumba

Dosage Form

single-dose prefilled syringe
Solution in a single-dose vial
single-dose prefilled syringe

Dosage

100mg
130mg
90mg

Endpoints

Efficacy evaluations will include the following:
Crohn’s Disease Activity Index (CDAI)
PRO-2 (the unweighted CDAI components of the total number of liquid or very soft stools
and the abdominal pain score)
 Endoscopic assessments based on the presence and absence of mucosal ulcerations and the
Simple Endoscopic Score for Crohn’s Disease (SES-CD)
 Histologic assessments based on the Global Histology Activity Score
 Inflammatory PD markers including CRP and fecal calprotectin
 Fistula assessment
 HRQOL outcome measures including Inflammatory Bowel Disease Questionnaire, PatientReported Outcomes Measurement Information System (PROMIS)-29, PROMIS Fatigue
Short Form 7a, and 5-level EuroQol five dimensions instrument
 Health economics outcome measures including the Work Productivity and Activity
Impairment Questionnaire in Crohn’s disease
 Exploratory patient-reported symptom measures including Bristol Stool Form Scale,
Abdominal Pain – Numerical Rating Scale, Patient’s Global Impression of Severity of
Crohn’s Disease, and Patient’s Global Impression of Change of Severity of Crohn’s Disease

Inclution Criteria

Inclusion Criteria:
Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
Have screening laboratory test results within the protocol specified parameters
A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria

Exclusion Criteria:
Current diagnosis of ulcerative colitis or indeterminate colitis
Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
Unstable doses of concomitant Crohn's disease therapy
Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
Any medical contraindications preventing study participation

The Estimated Number of Participants

Taiwan

13 participants
Global

1340 participants