Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Product Name: Ustekinumab
Product Code: CNTO 1275
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ustekinumab
Current Sponsor code: CNTO 1275
Other descriptive name: Hu
Human Anti-IL-12 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of admin
Human Anti-IL-12 Antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90 -
Pharmaceutical form of the placebo: Solution for injection
Route of administration of
Sponsors
Centocor BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy. - Have active disease, defined as a baseline CDAI score of = 220 and = 450. - Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn’s disease and: a. Did not respond initially (ie, primary nonresponders). or b. Responded initially but then lost response with continued therapy (ie, secondary nonresponders). or c. Were intolerant to the medication. - Are men or women who are = 18 years of age at time of consent. - Adhere to the following concomitant medication requirements relative to the first study agent administration at baseline (Week 0). a. 5-ASA compounds. b. Oral corticosteroids (eg, prednisone, budesonide) c. Crohn’s disease-specific antibiotics d. Immunomodulators: -Women of childbearing potential and all men must be using adequate birth control measures - Have the capacity to understand and sign an informed consent form. - Be able to adhere to the study visit schedule and other protocol requirements. - Have screening laboratory test results within the following parameters: - Hemoglobin > 8.5 g/dL - WBCs = 3.5 x 103/µL - Neutrophils = 1.5 x 103/µL - Platelets = 100 x 103/µL - Serum creatinine =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Have complications of Crohn’s disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with ustekinumab. - Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to baseline and are not anticipated to require surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present. - Have had any kind of bowel resection, diversion, or placement of a stoma within months or any other intra-abdominal surgery within 3 months prior to screening. - Have received treatment with total parenteral nutrition (TPN) within 2 weeks of screening. - Have a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. - Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study, or within 20 weeks after receiving the last dose of study agent. - Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to, ustekinumab (CNTO 1275) and ABT-874. - Have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer. - Have used any TNF antagonist = 8 weeks prior to the first administration of study agent or any other biologic = 12 weeks prior to the first administration of study agent or within 5 times the half-life of the biologic prior to the first administration of study agent, whichever is longer. - Have received natalizumab, efalizumab, or agents that deplete B or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population. - Have used apheresis (eg, Ada column apheresis) = 2 weeks prior to screening. - Have received any live bacterial or viral vaccination = 12 weeks prior to Week 0. Subjects must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last administration of study agent. - Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening. Subject must agree not to receive a BCG vaccination during the study or up to 12 months after the last study agent administration. - Have a history of, or ongoing, chronic or recurrent infectious disease. - Have current signs or symptoms of infection or history of serious infection. - Have evidence of a herpes zoster infection = 8 weeks of screening. - Have a history of latent or active granulomatous infection. - Have evidence of current active infection. - Have or ever have had a nontuberculous mycobacterial infection or serious opportunistic infection. - Are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C. - Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. - Have a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or have ever received stem cell therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ustekinumab in inducing clinical response. To evaluate the safety of ustekinumab.;Primary end point(s): Clinical response at Week 6;Secondary Objective: To evaluate the efficacy of ustekinumab in inducing clinical remission, fistula response, and mucosal healing. To obtain data to support selection of a maintenance dose regimen for continued clinical development. To explore the pharmacokinetics and pharmacodynamics of ustekinumab therapy. To evaluate the efficacy of ustekinumab in achieving delayed clinical response. | — |
Countries
Austria, Belgium, France, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed