Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2010-022759-42-GB |
Date of registration:
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02/06/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease
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Scientific title:
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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 |
Date of first enrolment:
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21/10/2011 |
Target sample size:
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612 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022759-42 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Brazil
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Bulgaria
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Canada
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Croatia
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Germany
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Hungary
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Iceland
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Israel
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Italy
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Japan
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Korea, Republic of
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Netherlands
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New Zealand
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Russian Federation
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South Africa
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+310715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+310715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Be a man or woman = 18 years of age.
2. Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
3. Have active Crohn’s disease, defined as:
a. A baseline CDAI score of 220 and 450,
AND
b. At least one of the following:
1) An abnormal CRP (> 0.3 mg/dL or > 3.0 mg/L) at screening;
OR
2) Calprotectin > 250 mg/kg at screening;
OR
3) Endoscopy with evidence of active Crohn’s disease during the current disease flare (defined as ulcerations in the ileum and/or colon). The endoscopy must have occurred within 3 months prior to baseline.
4. Meet the following requirements for prior or current medications for Crohn’s disease:
a. Has failed conventional therapy:
1) Is currently receiving corticosteroids and/or immunomodulators at adequate therapeutic doses;
OR
2) Has a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators;
OR
3) Is corticosteroid dependent or has had a history of corticosteroid dependency;
AND
b. Has not previously demonstrated inadequate response or intolerance to 1 or more TNF antagonist therapies.
5. Adhere to the following requirements for concomitant medication for the treatment of Crohn’s disease. The following medications are permitted provided doses meeting the requirements below are stable for or have been discontinued at least 3 weeks prior to baseline (Week 0), unless otherwise specified.
a. Oral 5-ASA compounds.
b. Oral corticosteroids at a prednisone-equivalent dose of = 40 mg/day or = 9 mg/day of budesonide.
c. Antibiotics being used as a primary treatment of Crohn’s disease.
d. Subjects receiving conventional immunomodulators must have been taking them for = 12 weeks, and on a stable dose for a least 4 weeks prior to baseline.
6. Have screening laboratory test results within the parameters mentioned in the protocol:
7. Are considered eligible according to the TB screening criteria mentioned in the protocol:
8. If a woman, before entry she must be:
a. Postmenopausal, defined as
1) > 45 years of age with amenorrhea for at least 18 months,
OR
2) > 45 years of age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL
OR
b. Menstrual
1) Surgically sterile, or
2) If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of th
Exclusion criteria: 1. 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.
2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified.
3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline.
4. Has a draining stoma or ostomy.
5. Has received any of the prescribed medications or therapies within the specified period (mentioned in the protocol).
6. 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.
7. Has previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874).
8. Has received a Bacille Calmette-Guérin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks of baseline.
9. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.
10. Has current signs or symptoms of infection. Established nonserious infections need not be considered exclusionary at the discretion of the investigator.
11. Has a history of serious infection, including any infection requiring hospitalization or IV antibiotics, for 8 weeks prior to baseline.
12. Has evidence of a herpes zoster infection = 8 weeks prior to baseline.
13. Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening. Refer to inclusion criteria for information regarding eligibility with a history of latent TB.
14. Has evidence of current active infection, including but not limited to TB (exceptions see protocol).
15. Has or ever has had a nontuberculous mycobacterial infection or serious opportunistic infection.
16. Is known to be infected with HIV, hepatitis B, or hepatitis C.
17. Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Moderately to severely active Crohn's disease
MedDRA version: 17.0
Level: PT
Classification code 10011401
Term: Crohn's disease
System Organ Class: 10017947 - Gastrointestinal disorders
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: The primary objectives are: - To evaluate the efficacy of IV induction regimens of Ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease. - To evaluate the safety of IV induction regimens of Ustekinumab in subjects with moderately to severely active Crohn’s disease.
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Primary end point(s): The primary endpoint is clinical response at Week 6, defined as a reduction from baseline in the CDAI score of = 100 points. Subjects 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.
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Timepoint(s) of evaluation of this end point: At week 6
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Secondary Objective: The secondary objectives are: - To evaluate the efficacy of IV induction regimens of Ustekinumab in inducing clinical remission. - To evaluate the efficacy of IV induction regimens of Ustekinumab in improving disease-specific health-related quality of life. - To evaluate the pharmacokinetics and pharmacodynamics of Ustekinumab therapy, including changes in C-reactive protein (CRP), fecal calprotectin, fecal lactoferrin, and other pharmacodynamic biomarkers. - To provide, along with induction study CNTO1275CRD3001, the target study population to be evaluated in the maintenance study CNTO1275CRD3003.
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Secondary Outcome(s)
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Secondary end point(s): The major secondary endpoints, in order of importance, are:
1. Clinical remission at Week 8, defined as a CDAI score of < 150 points.
2. Clinical response at Week 8.
3. 70-point response at Week 6, defined as a reduction from baseline in the CDAI score of = 70 points.
4. 70-point response at Week 3.
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Timepoint(s) of evaluation of this end point: At week 3, 6 and 8
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Secondary ID(s)
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2010-022759-42-DE
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CNTO1275CRD3002
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Source(s) of Monetary Support
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Janssen R&D
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Ethics review
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Status: Approved
Approval date:
Contact:
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