None listed
Conditions
Interventions
Drug : Subjects are randomly allocated to either Arm-1 or Arm-2. Subjects in both arms receive UST biosimilar (SB17: EPYZTEK®) IV in Week 0 (~6 mg/kg: 260mg for body weight =55 kg, 390mg for those >55
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 19 years of age or over 2. Patients confirmed as Crohn's disease based on clinical, laboratory, endoscopic, imaging, and pathologic findings 3. Patients receiving maintenance treatment with Ustekinumab (UST) 90 mg SC (subcutaneous) q 8 weeks 4. Patients who show a secondary loss of response to UST : All of the three criteria below should be satisfied with. 1) Clinical response in W16-20 after UST induction therapy (W0 UST IV ~6 mg/kg + W8 UST SC 90 mg) (CDAI reduction = 70 points or CDAI reduction = 25%) 2) Clinical activity during UST 90 mg SC q 8 weeks maintenance treatment (CDAI = 150) 3) Biochemical activity during UST 90 mg SC q 8 weeks maintenance treatment (CRP = 0.5 mg/dL or fecal calprotectin = 250 mg/kg) 5. SES-CD =3 ( 6. If oral corticosteroids are being used at the baseline, the dose should be: prednisolone = 20 mg/day or equivalent or budesonide = 9 mg/day or beclomethasone dipropionate = 5 mg/day : This dose should be in stable dose for at least two weeks. 7. Women with a childbearing potential, who are going to use appropriate contraception methods during the study period or men who have a female partner of childbearing age (central reading) 8. Subjects who understands the research procedure and voluntarily agrees in writing to the consent form 9. Subjects who can comply with the requirements of the study visit schedule and other research procedures
Exclusion criteria
Exclusion criteria: 1. Patients who have ever received UST IV re-induction treatment or UST SC maintenance treatment at shorter intervals than every 8 weeks (However, -7 days are allowed for UST SC maintenance treatment as shorter intervals) 2. Failure of three or more biologics small molecule drugs: Numbers are defined according to mode of action (e.g., anti-TNF drugs are counted as one). 3. Concomitant biologics or small molecule drugs co-administered with UST 4. One or more laboratory values at baseline: Hemoglobin 1.4 mg/dL, aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal range 5. a) symptomatic intestinal stricture or symptomatic entero-enteric fistula b) untreated intra-abdominal abscess, c) untreated perianal abscess, d) intestinal resection within 6 months or any kind of abdominal surgery within 3 months, e) patients who are expected to receive Crohn's disease-related intestinal surgery during the study period. However, perianal abscess appropriately drained more than 4 weeks before baseline, and intra-abdominal abscesses appropriately drained more than 8 weeks before baseline can be included. 6. Subjects with hepatitis B virus surface antigen (HBsAg) positivity. Even if HBsAg is negative, if IgG anti-HBc is positive, a real time quantitative PCR for HBV DNA should be performed. If HBV DNA >= 10 IU/mL, that subjected is excluded. 7. Subjects positive for antibodies to hepatitis C virus 8. Subjects with a history of or positive HIV infection 9. Patients with an active infection or malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, or cervical carcinoma) or a history of dysplasia of the large or small intestine within the previous 5 years 10. Subjects with a stoma 11. Subjects with short bowel syndrome 12. Subjects with active (draining) enterocutaneous fistula 13. Pregnant or nursing woman 14. Men who have a female partner of childbearing age or Women with a childbearing potential who are not under appropriate contraception and do not plan to do appropriate contraception methods for at least 6 months after the last dosing of SB17 (hormonal contraceptives of oral, injectable or implantable forms, diaphragms, condoms, intrauterine devices, or abstinence are regarded as appropriate contraception). 15. Subjects not appropriate for the study according to the investigator’s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportions of patients who achieve clinical response (Crohn’s Disease Activity Index =70 decrease from baseline);Proportions of patients who achieve endoscopic response: any of the following three criteria - >=50% dcrease of Simple Endoscopic Score-Crohn's disease from baseline, or - Simple Endoscopic Score-Crohn's disease <=3, or - Simple Endoscopic Score-Crohn's disease=0 in cases of baseline Simple Endoscopic Score-Crohn's disease=3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients who achieve clinical response (Crohn’s Disease Activity Index =70 decrease from baseline);Proportions of patients who achieve clinical remission (Crohn’s Disease Activity Index =70 decrease from baseline + No use of systemic corticosteroids for at least 8 weeks));Proportions of patients who achieve corticosteroid-free clinical remission (Crohn’s Disease Activity Index = 0.5 mg/dL, - fecal calprotectin =250 mg/kg;Proportions of patients achieving normalization of C-Reactive Protein and/or fecal calprotectin;Proportions of patients developing Treatment Emergent Adverse Event ;Proportions of patients developing Serious Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Ja Youn
Asan Medical Center
Outcome results
None listed