Crohn Disease
Conditions
Brief summary
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
Interventions
DRUGGuselkumab (GUS)
Guselkumab will be administered intravenously or by subcutaneous injection.
Sponsors
Xian-Janssen Pharmaceutical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a confirmed diagnosis of Crohn's disease (CD) * Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 * Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks * Initially responded to UST induction therapy and then lose response to UST * During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
Exclusion criteria
* Received UST dose optimization or multiple intravenous therapy in maintenance phase * Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months * Is currently enrolled in an interventional clinical study * Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome * Have a current or be suspected to have an abscess
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission At Week 48 | At Week 48 | Clinical remission is defined as less than (\<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48 | At Weeks 12, 24 and 48 | Clinical response is defined as greater than or equal to (\>=) 100-point reduction from baseline in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
| Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24 | At Weeks 12 and 24 | Clinical remission is defined as \< 150-point reduction in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
| Percentage of Participants Achieving Endoscopic Response | At Weeks 24 and 48 | Endoscopic response is defined as \>= 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis \[single or multiple, and whether the colonoscopy could pass through the narrow lumen\]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease. |
| Percentage of Participants Achieving Endoscopic Remission | At Weeks 24 and 48 | Endoscopic remission is defined as SES-CD less than or equal to (\<=) 2 in any individual component. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis \[single or multiple, and whether the colonoscopy could pass through the narrow lumen\]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease. |
| Baseline Characteristics of Participants With Endoscopic Remission: Age | Baseline | Baseline characteristics of participants (age) with endoscopic remission will be reported. |
| Baseline Characteristics of Participants With Endoscopic Remission: Sex | Baseline | Baseline characteristics of participants (sex) with endoscopic remission will be reported. |
| Baseline Characteristics of Participants With Endoscopic Remission: Height | Baseline | Baseline characteristics of participants (height) with endoscopic remission will be reported. |
| Baseline Characteristics of Participants With Endoscopic Remission: Weight | Baseline | Baseline characteristics of participants (weight) with endoscopic remission will be reported. |
| Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications | Baseline | Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported. |
| Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities | Baseline | Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported. |
| Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures | Baseline | Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported. |
Countries
China
Contacts
CONTACTStudy Contact
STUDY_DIRECTORXi'an Janssen Pharmaceutical Clinical Trial
Xi'an Janssen Pharmaceutical
Outcome results
None listed