Clinical trial NCT05029921: A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-09-01
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical and endoscopic efficacy and safety of ustekinumab in Chinese participants with moderately to severely active Crohn's disease.


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

Primary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)
timeFrame: Week 8
measure: Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 52 (Major Secondary Endpoint)
timeFrame: Week 52
measure: Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 8 (Major Secondary Endpoint: Co-endpoint)
timeFrame: Week 8
measure: Percentage of Participants with Endoscopic Remission at Week 16 (Major Secondary Endpoint: Co-endpoint)
timeFrame: Week 16
measure: Percentage of Participants with Endoscopic Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Endoscopic Remission at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Clinical Remission at Week 3
timeFrame: Week 3
measure: Percentage of Participants with PRO-2 Remission at Weeks 3 and 52
timeFrame: Weeks 3 and 52
measure: Percentage of Participants with Clinical Response at Weeks 3, 8, and 52
timeFrame: Weeks 3, 8, and 52
measure: Percentage of Participants with Clinical Remission at Week 52 (in Participants Induced into Clinical Remission with Ustekinumab at Week 8)
timeFrame: Week 52
measure: Percentage of Participants with Corticosteroid-free Remission at Week 52
timeFrame: Week 52
measure: Change from Baseline in C-reactive Protein (CRP) Concentration at Week 3, Week 8, and Week 52
timeFrame: Baseline, Week 3, Week 8, and Week 52
measure: Percentage of Participants with Normalization of CRP at Weeks 3, 8, and 52
timeFrame: Weeks 3, 8, and 52
measure: Change from Baseline in Fecal Calprotectin Concentration at Week 8 and Week 52
timeFrame: Baseline, Week 8, and Week 52
measure: Percentage of Participants with Normalization of Fecal Calprotectin at Weeks 8 and 52
timeFrame: Weeks 8 and 52
measure: Percentage of Participants with Fistula Response at Weeks 8 and 52
timeFrame: Weeks 8 and 52
measure: Percentage of Participants with Clinical Remission of Delayed Responders at Week 52
timeFrame: Week 52
measure: Percentage of Participants with PRO-2 Remission of Delayed Responders at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Clinical Response of Delayed Responders at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Endoscopic Response of Delayed Responders at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Endoscopic Remission of Delayed Responders at Week 52
timeFrame: Week 52
measure: Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 and Week 52
timeFrame: Baseline, Week 8 and Week 52
measure: Percentage of Participants with IBDQ Response at Weeks 8 and 52
timeFrame: Weeks 8 and 52
measure: Percentage of Participants with IBDQ Remission at Weeks 8 and 52
timeFrame: Weeks 8 and 52
measure: Percentage of Participants Having any Crohn's Disease (CD)-related Emergency Room (ER)/Hospitalizations (Including Surgeries) Through Week 8 and Week 52
timeFrame: Weeks 8 and 52
measure: Percentage of Participants Having any CD-related Surgery and Procedure Through Week 8 and Week 52
timeFrame: Weeks 8 and 52
measure: Change from Baseline in Each of 4 Impairments from Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI-CD) at Week 8 and Week 52
timeFrame: Baseline, Week 8, and Week 52
measure: Percentage of Participants with a 7-point Change from Baseline in Each of 4 Impairments from WPAI-CD at Week 8 and Week 52
timeFrame: Baseline, Week 8, and Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: The Military General Hospital of Beijing PLA
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Changzhou
country: China
facility: Changzhou No 2 Peoples Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Hefei
country: China
facility: Anhui Province Hospital
city: Huzhou
country: China
facility: Huzhou central hospital
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Ningbo
country: China
facility: Ningbo medical center lihuili hospital
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai 10th Peoples Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Suzhou
country: China
facility: The Second Hospital Affiliated To Suzhou University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: