A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT04397263|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohns Disease||Drug: Guselkumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||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|
|Actual Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||September 30, 2024|
Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.
Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Other Name: CNTO1959
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.
- Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score [ Time Frame: 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. .
- Change from Baseline in Patient-Reported Outcome (PRO)-2 Score [ Time Frame: 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.
- Change from Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) Score [ Time Frame: 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.
- Serum Concentation of Guselkumab [ Time Frame: Up to Week 48 ]Serum concentration of Guselkumab will be reported.
- Number of Participants with Anti-Guselkumab Antibodies [ Time Frame: Up to Week 48 ]Number of participants with anti-Guselkumab antibodies will be reported.
- Change from Baseline in C-reactive protein (CRP) [ Time Frame: Baseline and Week 4, 8, 12, 16, 20, 24, 32, 40 and 48 ]Change from baseline in C-reactive protein (CRP) will be reported.
- Change from Baseline in Fecal Calprotectin (FC) Levels [ Time Frame: Baseline and Week 4, 8, 12, 24 and 48 ]Change from baseline in Fecal Calprotectin (FC) Levels will be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397263
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|