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Completed

NCT Number: NCT05029921

A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ustekinumab

Drug

Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.

Other names: STELARA

Primary outcomes

  1. Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)

    Time frame: Week 8

    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.

  2. Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)

    Time frame: Week 16

    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]).

Secondary outcomes

  1. Percentage of Participants with Clinical Remission at Week 52 (Major Secondary Endpoint)

    Time frame: Week 52

    Percentage of participants with clinical remission at Week 52 will be reported.

  2. Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 8 (Major Secondary Endpoint: Co-endpoint)

    Time frame: Week 8

    PRO-2 remission is defined as an AP mean daily score at or below 1 (AP<=1) and a stool frequency (SF) mean daily score at or below 3 (SF<=3), and no worsening of AP or SF from baseline.

  3. Percentage of Participants with Endoscopic Remission at Week 16 (Major Secondary Endpoint: Co-endpoint)

    Time frame: Week 16

    Endoscopic remission is defined as SES-CD score of <= 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]).

  4. Percentage of Participants with Endoscopic Response at Week 52

    Time frame: Week 52

    Percentage of participants with endoscopic response at Week 52 will be reported.

  5. Percentage of Participants with Endoscopic Remission at Week 52

    Time frame: Week 52

    Percentage of participants with endoscopic remission at Week 52 will be reported.

  6. Percentage of Participants with Clinical Remission at Week 3

    Time frame: Week 3

    Percentage of participants with clinical remission at Week 3 will be reported.

  7. Percentage of Participants with PRO-2 Remission at Weeks 3 and 52

    Time frame: Weeks 3 and 52

    Percentage of participants with PRO-2 remission at Weeks 3 and 52 will be reported.

  8. Percentage of Participants with Clinical Response at Weeks 3, 8, and 52

    Time frame: Weeks 3, 8, and 52

    Clinical response is defined as a CDAI score decrease greater than or equal to (>=) 100 from baseline. Participants with a baseline CDAI score of >=220 to <=248 points are considered to be in clinical response if a CDAI score of <150 is attained.

  9. Percentage of Participants with Clinical Remission at Week 52 (in Participants Induced into Clinical Remission with Ustekinumab at Week 8)

    Time frame: Week 52

    Percentage of participants with clinical remission at Week 52 (in participants induced into clinical remission with ustekinumab at Week 8) will be reported.

  10. Percentage of Participants with Corticosteroid-free Remission at Week 52

    Time frame: Week 52

    Corticosteroid-free remission is defined as a CDAI score <150 and not taking any corticosteroids for at least 30 days or 90 days prior to Week 52.

  11. Change from Baseline in C-reactive Protein (CRP) Concentration at Week 3, Week 8, and Week 52

    Time frame: Baseline, Week 3, Week 8, and Week 52

    Change from baseline in CRP concentration at Week 3, Week 8, and Week 52 will be reported.

  12. Percentage of Participants with Normalization of CRP at Weeks 3, 8, and 52

    Time frame: Weeks 3, 8, and 52

    Percentage of participants with normalization of CRP at Weeks 3, 8, and 52 with elevated CRP (>3.0 milligrams per liter [mg/L]) at baseline will be reported.

  13. Change from Baseline in Fecal Calprotectin Concentration at Week 8 and Week 52

    Time frame: Baseline, Week 8, and Week 52

    Change from baseline in fecal calprotectin concentration at Week 8 and Week 52 will reported. Fecal Calprotectin will be monitored as an inflammatory biomarker measured by assay.

  14. Percentage of Participants with Normalization of Fecal Calprotectin at Weeks 8 and 52

    Time frame: Weeks 8 and 52

    Percentage of participants with normalization of fecal calprotectin at Weeks 8 and 52 with elevated fecal calprotectin (>250 milligrams per kilograms [mg/kg]) at baseline will be reported.

  15. Percentage of Participants with Fistula Response at Weeks 8 and 52

    Time frame: Weeks 8 and 52

    Fistula response is defined as a >=50% reduction in the number of draining fistulas, among participants with 1 or more fistulas at baseline.

  16. Percentage of Participants with Clinical Remission of Delayed Responders at Week 52

    Time frame: Week 52

    Percentage of participants with clinical remission of delayed responders at Week 52 will be reported. Delayed responders are participants who are not in clinical response to ustekinumab at Week 8 and achieve clinical response at Week 16.

  17. Percentage of Participants with PRO-2 Remission of Delayed Responders at Week 52

    Time frame: Week 52

    Percentage of participants with PRO-2 remission of delayed responders at Week 52 will be reported.

  18. Percentage of Participants with Clinical Response of Delayed Responders at Week 52

    Time frame: Week 52

    Percentage of participants with clinical response of delayed responders at Week 52 will be reported.

  19. Percentage of Participants with Endoscopic Response of Delayed Responders at Week 52

    Time frame: Week 52

    Percentage of participants with endoscopic response of delayed responders at Week 52 will be reported.

  20. Percentage of Participants with Endoscopic Remission of Delayed Responders at Week 52

    Time frame: Week 52

    Percentage of participants with endoscopic remission of delayed responders at Week 52 will be reported.

  21. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 and Week 52

    Time frame: Baseline, Week 8 and Week 52

    IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

  22. Percentage of Participants with IBDQ Response at Weeks 8 and 52

    Time frame: Weeks 8 and 52

    Percentage of participants with IBDQ response (>=16-point improvement from baseline) at Weeks 8 and 52 will be reported.

  23. Percentage of Participants with IBDQ Remission at Weeks 8 and 52

    Time frame: Weeks 8 and 52

    Percentage of participants with IBDQ remission (>170-point) at Weeks 8 and 52 will be reported.

  24. Percentage of Participants Having any Crohn's Disease (CD)-related Emergency Room (ER)/Hospitalizations (Including Surgeries) Through Week 8 and Week 52

    Time frame: Weeks 8 and 52

    Percentage of participants having any CD-related ER/hospitalizations (including surgeries) through Week 8 and Week 52 will be reported.

  25. Percentage of Participants Having any CD-related Surgery and Procedure Through Week 8 and Week 52

    Time frame: Weeks 8 and 52

    Percentage of participants having any CD-related surgery and procedure through Week 8 and Week 52 will be reported.

  26. 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

    Time frame: Baseline, Week 8, and Week 52

    The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.

  27. Percentage of Participants with a 7-point Change from Baseline in Each of 4 Impairments from WPAI-CD at Week 8 and Week 52

    Time frame: Baseline, Week 8, and Week 52

    The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2021
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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