A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
Numaguchi Hirotaka
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
completed
Oct. 14, 2020
25
Interventional
No Masking, Single arm study, Uncontrolled, Single assignment, No Placebo, No Allocation
treatment purpose
3
- Have Crohn's Disease (CD) or fistulizing CD 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 components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
- 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
- Has complications of CD, 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 time frame as specified in the protocol
- Prior exposure to p40 inhibitors or p19 inhibitors
- Any medical contraindications preventing study participation
18age old over
No limit
Both
Crohn's Disease
investigational material(s)
Generic name etc : Guselkumab
INN of investigational material : Guselkumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
safety
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Up to Week 48
An Adverse Event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.
efficacy
Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score
Baseline to Week 48
The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with score ranges from 0 to approximately 600. A decrease over time indicates improvement in disease activity.
efficacy
Change from Baseline in Patient- Reported Outcome (PRO)-2 Score
Baseline to Week 48
PRO-2 is based on unweighted CDAI components of the total number of liquid or very soft stools and the abdominal pain (AP) score. The PRO-2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
efficacy
Change from Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) Score
Baseline and Week 48
The SES-CD score will be used to evaluate endoscopic improvement based on presence/size of ulcers, mucosal surface covered by ulcers, mucosal surface affected by any other lesions, and presence/type of narrowing/structures) across 5 ileocolonic segments.
pharmacokinetics
Serum Concentation of Guselkumab
Up to Week 48
Serum concentration of Guselkumab will be reported.
pharmacodynamics
Number of Participants with Anti-Guselkumab Antibodies
Up to Week 48
Number of participants with anti- Guselkumab antibodies will be reported.
pharmacodynamics
Change from Baseline in C-reactive protein (CRP)
Baseline and Week 4, 8, 12, 16, 20, 24, 32, 40 and 48
Change from baseline in C-reactive protein (CRP) will be reported.
pharmacodynamics
Change from Baseline in Fecal Calprotectin (FC) Levels
Baseline and Week 4, 8, 12, 24 and 48
Change from baseline in Fecal Calprotectin (FC) Levels will be reported
