Crohn's disease MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: TRK-170
Product Code: TRK-170
Pharmaceutical Form: Film-coated tablet
CAS Number: 894404-71-8
Current Sponsor code: TRK-170
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Toray Industries Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient has to meet all of the following criteria to be eligible to enter the study: 1) Male and female patients aged 18 to 50 years 2) Patient has a diagnosis of CD at least 4 months prior but not more than 10 years before screening. The diagnosis should have been confirmed by endoscopic findings including histological examination 3) Patient has had disease activity with lesions in the colon within the past 12 months before dosing, as confirmed by ileocolonoscopy 4) Patient with moderately active CD at time of screening defined as a CDAI score of between 220 and 450 5) Patient has stable disease activity (stable for = 2 weeks prior to screening) and not foreseen to require treatment with high dose steroids or other short term, potent treatments (e.g. TNF-a inhibitors) during the study period 6) Patient has an increased CRP level (> upper limit of normal) at screening, as a sign of active disease, as judged by the investigator 7) Patient with a body weight of greater than 50 kg but less than 120 kg 8) Patient willing and able to participate in the study and provide signed informed consent 9) Patient agrees to use adequate contraceptive measures, in other words, Female patient who has not been post-menopausal for more than 3 months or female patients of childbearing potential must use adequate contraception (i.e. a method with less than 1% failure rate [e.g. diaphragm or condom used in combination with spermicidal cream, sterilization, an intrauterine device, or a vasectomised partner]) during and for at least 3 months after the last dose of IP. Females using hormonal contraception methods must also use an additional contraception method (as described above) during and for at least 3 months after the last dose of IP or Male patient who agrees to use condoms in combination with spermicidal cream during the study and for three months after the last dose of the IP, or patient who has a female partner using adequate contraception as described above Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 609 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient meeting any of the following criteria will not be permitted to enter the study: 1) Increased risk of hypersensitivity or allergy to the IP or placebo product as judged by the investigator 2) Patient has had a clinically significant illness within 4 weeks prior to screening, at the Investigator’s discretion, or history of any severe liver disease with cirrhosis, active hepatitis or chronic hepatitis 3) Patient with clinically significant deviations in laboratory values as determined by the Investigator, high level(s), e.g., 2X upper limit of normal of ALT, AST, ALP, GGT or total bilirubin at screening indicative of hepatic impairment. Laboratory values >3X upper limit of normal will be a strict criteria for exclusion 4) Patient who had a serious infection within 3 months, opportunistic infection within one month, or current signs or symptoms of severe, progressive or uncontrolled disease 5) Severe renal impairment defined as a predicted creatinine clearance of 30 mL/min or less, based on the Cockroft-Gault equation 6) Patient has a history of cancer or lymphoproliferative disease within the last 5 years 7) History of substance or alcohol abuse within the past one year prior to screening 8) Positive viral test result for hepatitis B or C or human HIV 1 or 2 or positive pre-study testing for major drugs of abuse or excessive alcohol consumption 9) Chest X-ray positive or suspected positive for active tuberculosis 10) Female patient currently pregnant or breast-feeding or intending to become pregnant during the study or within three months after the last dose of the IP 11) Female patient of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrollment 12) Patient currently has gastrointestinal disease other than CD (e.g., ulcerative colitis, short bowel syndrome, malabsorption, intestinal obstruction). This includes patients with an ostomy, ileal pouch, a previous ileo-rectal anastomosis, a history of procto-colectomy but not subtotal colectomy, draining fistula or abscess or are receiving enteral nutrition via a feeding tube or parenteral nutrition 13) Treatment with immunosuppressants or anti-cancer drugs (e.g., azathioprine, 6-MP, 6-thioguanin, methotrexate, mycophenolate mofetil, sirolimus (rapamycin), tacrolimus, thalidomide, cyclophosphamide, or cyclosporine) within the last 3 months prior to screening 14) Treatment with intravenous or rectal steroids for CD, antibiotics (e.g., metronidazole or ciprofloxacin) or continued repeated use of nonsteroidal anti-inflammatory agents (NSAIDs) within 2 weeks prior to screening 15) Treatment with Tysabri® or inhibitors of TNF-a within 8 weeks prior to screening 16) Treatment with a 5-ASA formulation (oral mesalazine) above 2.5 g/day within 1 week prior to screening 17) Patient who changed the dose of oral corticosteroids within 2 weeks prior to screening or ongoing treatment with prednisolone exceeding 25 mg/day or corresponding doses of other corticosteroids 18) Patient who stopped using oral corticosteroids within 4 weeks prior to screening 19) Patient has previous treatment failure or had an inadequate response or intolerance to biologic drugs for CD (e.g., Tysabri® or inhibitors of TNF-a) 20) Patient who had a previous GI surgical procedure (except appendectomy and ileocecal resection) within 8 weeks of screening or foreseen to need GI surgery during the study 21) Patient has contributed blood (e.g., blood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective: Part A To evaluate the effect of TRK-170 on mucosal healing as measured by Crohn's Disease Endoscopic Index of Severity (CDEIS) score based on ileocolonoscopy and use this evaluation to decide which dose(s) of TRK- 170 should be used in Part B Part B To evaluate the efficacy of TRK-170 in patients with active CD as measured by CDAI score;Secondary Objective: The secondary objectives are: Part A - to evaluate the efficacy of TRK-170 in patients with active CD as measured by CDAI score Part A and Part B - to evaluate the safety and tolerability of TRK-170 in patients with active CD - to evaluate the PK characteristics of TRK-170 in patients with active CD - to evaluate the effect of TRK-170 on faecal calprotectin excretion - to evaluate the effect of TRK-170 on C-reactive protein (CRP) in plasma - to evaluate the effect of TRK-170 on the Inflammatory Bowel Disease Questionnaire (IBDQ) score - to evaluate the PK-pharmacodynamic (PD) relationship of TRK-170 for variables that may be affected by the treatment, i.e., CDEIS (Part A only), CDAI and IBDQ scores, faecal calprotectin and plasma CRP levels;Primary end point(s): Part A Change in CDEIS score from baseline to end of treatment (week 8) Part B The proportion of patients in remission as defined by a CDAI score of <150 at end of treatment (week 8);Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated at Day 56 (+/-3 days)Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A - The proportion of patients in remission as defined by a CDAI score of <150 at end of treatment (week 8) Part A and Part B - Proportion of responders as defined by a reduction in CDAI score by at least 70 at week 8 compared to baseline - Safety and tolerability of TRK-170 in patients with active CD as assessed by adverse events (AEs), vital signs and laboratory parameters - PK characteristics of TRK-170 - Changes in faecal calprotectin concentration from baseline to week 8 - Changes in plasma CRP levels from baseline to week 8 - Changes in IBDQ score from baseline to week 8;Timepoint(s) of evaluation of this end point: All secondary endpoints will be evaluated at Day 56 (+/-3 days)Week 8 | — |
Countries
Belgium, Bulgaria, Czech Republic, Hungary, Latvia, Netherlands, Norway, Poland, Sweden
Contacts
Public ContactProject leader - Anders Nilsson
TFS
Outcome results
None listed