None listed
Conditions
Interventions
Drug : • Medicinal Product
- Product name: Kynteles Inj.
- Pharmaceutical form: Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder
- Manufacturer: Takeda
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject who are 19–80 years of age 2) Subject who has moderately to severely active CD (CDAI score 220–450) during the screening period 3) Subject who has ileocolonoscopy with SES-CD ? 6 for ileocolonic CD or ? 4 including ulcer score from ? 1 segment for ileal CD or colonic CD during the screening period 4) Subject who has failed, lost response to, or been intolerant to two or more classes of conventional therapy: corticosteroids and immunomodulators [e.g., azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX)] 5) Subject who did not receive corticosteroids or received stable dose of corticosteroids (dose has been stable for 4 weeks immediately prior to enrollment if corticosteroids have been initiated, or for 2 weeks immediately prior to enrollment if corticosteroids are being tapered) 6) Subject who has no prior or current treatment of the following agents: infliximab, adalimumab, ustekinumab, janus kinase (JAK) inhibitor, vedolizumab, or respective biosimilars 7) (If subject has an experience to be enrolled in the clinical trial) Subject was treated by placebo and did not receive any study drug for inflammatory bowel disease (IBD) treatment (e.g., small molecules or biologics)
Exclusion criteria
Exclusion criteria: 1) Subject who has been diagnosed as ulcerative colitis (UC) or indeterminate colitis 2) Subject who has prior or current treatment of the following agents: biologics, JAK inhibitor, respective biosimilars, or any study drug in clinical trials 3) Subject who had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, etrolizumab, or ontamalimab 4) Subject who has symptomatic intestinal stricture, internal fistula, abdominal abscess, stoma or any other manifestation that might be anticipated to require intestinal surgery 5) Subject who has a history of intestinal surgery related with CD 6) Subject who had hospitalizations related to CD complications in 12 months prior to enrolment 7) Subject has contraindication to colonoscopy 8) Pregnant or lactating females 9) Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods 10) Subject who has current active tuberculosis (TB) infection, TB infection history without documentation of cure after standard anti-TB treatment, or latent TB infection without treatment or less than 4 weeks treatment of latent TB infection before enrollment 11) Subject who has severe active infections such as sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML) 12) Subject who has following condition: History or presence of chronic hepatitis B or C infection, colonic dysplasia or cancer 13) Subject who had experience of treatment with a drug or a medical device due to participation in another clinical trial within 3 months from the date of consent 14) Subject who has conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinical remission (CDAI < 150);Proportion of subjects with endoscopic response (SES-CD reduction ? 50%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinical response (CDAI decrease ?100);Proportion of subjects with clinical response (CDAI decrease ? 70);Proportion of subjects with clinical remission (CDAI < 150);Proportion of subjects with steroid-free clinical remission (CDAI < 150 without corticosteroid treatment within two weeks) ;Proportion of subjects with endoscopic remission (SES-CD ?2);Proportion of subjects with combined clinical and endoscopic remission;Changes in serum drug concentration from baseline;Change in CRP mg/dL (Normal limit will be <0.5 or 0.6 mg/dL) from baseline;Change in fecal calprotectin µg/g (Normal limit: <150 µg/g) from baseline;Proportion of subjects with decrease of ?50% in individual scores of AP and LSF;Daily changes in PRO scores in the first 14 days;Weekly changes in PRO2 score from baseline;Proportion of subjects with clinical response of PRO2 (decrease of ?50% composite scores of AP and LSF);Proportion of subjects with clinical remission of PRO2 (AP ? 1 and LSF ? 3);Proportion of subjects with combined endoscopic and clinical remission of PRO2;Proportion of subjects with radiologic remission for each segment (simplified MaRIA score <1 across all bowel segments in those subjects with baseline score of ?1);Difference in median score and median change from baseline of global simplified MaRIA between subjects with endoscopic remission (SES- CD ?2) and those without, as well as between subjects with endoscopic response (SES-CD reduction ?50%) and those without;Changing pattern in the compositions of fecal microbiome from baseline to week ;Changing patterns in the composition of fecal and serum metabolites from baseline ;Change in the IBDQ score from baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Hwan Choi
Chung-Ang Univerisity Hospital
Outcome results
None listed