A Study of Ustekinumab (STELARA) in Chinese Participants... | NCT05029921

ID	Type	Description	Link
CNTO1275CRD4030	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ustekinumab	Experimental	Participants will receive a single dose of ustekinumab intravenously (IV) (weight-based dose approximating 6 milligrams per kilogram [mg/kg]) at Week 0. Participants with body weight less than or equal to (<=) 55 kg will receive ustekinumab IV of 260 mg, greater than (>) 55 kg and <=85 kg will receive ustekinumab IV of 390 mg, and >85 kg will receive ustekinumab IV of 520 mg at Week 0 in induction phase followed by ustekinumab 90 mg subcutaneously (SC) in maintenance phase from Week 8 to Week 52. For participants who achieve clinical response with ustekinumab induction dosing at Week 8, will continue to receive 90 mg ustekinumab SC every 12 weeks with final dose at Week 44. If these participants meet the criteria for loss of response from Week 16 to Week 40, dose can be adjusted to 90 mg every 8 weeks (q8w). Participants who are non-responders to ustekinumab at Week 8, and achieve clinical response at Week 16, will continue to receive ustekinumab 90 mg SC q8w from Week 16 to Week 48.	Drug: Ustekinumab

Name	Type	Description	Arm Group Labels	Other Names
Ustekinumab	Drug	Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.	Ustekinumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)	Clinical remission is defined as a crohn's disease activity index (CDAI) score of less than (<) 150 (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain [AP]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis.	Week 8
Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)	Endoscopic response is defined as at least 50 percent (%) improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or SES-CD score less than or equal to (<=) 2. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, percentage of mucosal surface covered by ulcers, the percentage of affected surface, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 56 [the most severe endoscopic activity]).	Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Clinical Remission at Week 52 (Major Secondary Endpoint)	Percentage of participants with clinical remission at Week 52 will be reported.	Week 52
Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 8 (Major Secondary Endpoint: Co-endpoint)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed in the past by radiography, histology, and/or endoscopy
Have moderately to severely active CD, defined as a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450, and either: a. Mean daily stool frequency (SF) count >3, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily abdominal pain (AP) score >1, based on the unweighted CDAI component of AP
Have endoscopic evidence of active ileocolonic CD as assessed by central endoscopy reading at the screening endoscopy, defined as a screening simple endoscopic score for crohn's disease (SES-CD) score >=6 (or >=4 for participants with isolated ileal disease), based on the presence of ulceration in at least 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. a minimum score of 1 for the component of "size of ulcers"; and b. a minimum score of 1 for the component of "ulcerated surface"
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at baseline
Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
Has previously demonstrated lack of initial response (that is, primary nonresponders), responded initially but then lost response with continued therapy (that is, secondary nonresponders) to Vedolizumab
Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers
History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly or monoclonal gammopathy of undetermined significance
Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing		100191	China
The Military General Hospital of Beijing PLA

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins