A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-019558-42-BE
• Date of registration: 13/10/2010
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Ltd.
• Public title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis
• Date of first enrolment: 23/12/2010
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019558-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Randomised, Double-Blind, Placebo-Controlled Pilot Study If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Czech Republic, Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
3.Must have an established diagnosis of UC for at least 3 months and have at least 1 previous relapse.
4. Must have a flexible sigmoidoscopy (or colonoscopy if required) indicative of active UC as close to randomization as possible.
5. Must have >15 cm of active disease at Screening endoscopy.
6. Subjects diagnosed with UC for >10 years must have had a colonoscopy within 12 months of Week 0 to exclude dysplasia and neoplasia.
7. Must have active UC with a Total Mayo Score of 6 to 10 points and moderate to severe disease on endoscopy (Mayo endoscopic subscore of at least 2).
8. Subjects must complete a UC symptom collection diary as assessed during the Screening period.
9. Must have high sensitivity C-reactive protein (hsCRP) =2.87 mg/L.
10. All male subjects and female subjects of child bearing potential must be willing and able to continue contraception for 6 months after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Subjects with a diagnosis of indeterminate colitis or Crohn’s disease.
2. Subjects with an imminent need for surgery.
3. Subjects with toxic megacolon.
4. Subjects with primary sclerosing cholangitis.
5. Subjects with known colonic stricture.
6. Subjects with a history of colonic or small bowel obstruction or resection.
7. Stool culture positive with confirmatory re-test, for enteric infection, including parasitic infection, and C. difficile toxin
8. Subjects with a history of malignant disease, including solid tumors and hematologic malignancies
9. History of severe allergic or anaphylactic reactions
10. History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease
11. Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with antibiotics within 4 weeks of Week 0.
12. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 6 months prior to Week 0.
13. Subjects with any laboratory test result at Screening considered clinically important (as determined by the Investigator) or:•alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.0 × upper limit of normal (ULN) •Hemoglobin =8.5 g/dL •Neutrophils <1.5 × 103/µL •Platelet count <150,000 cells/µL
14. Known history of, or positive test result for hepatitis B or C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb])
15. Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection
16. History of tuberculosis (TB) or positive PPD (positive Mantoux test defined as 10 mm of induration [size of raised lump, not redness]), or equivalent positive TB test result as per country clinical standards during the screening period.
17. Clinically important chest x-ray abnormality at Screening
18. If receiving corticosteroid treatment orally, subjects must have been on a stable dose (=20 mg prednisolone or equivalent per day) for at least 1 week prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 12.
19. If receiving 6-mercaptopurine or azathioprine (=2.5 mg/kg) treatment orally, subjects must have been on a stable dose for at least 8 weeks prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 24.
20. If receiving 5-aminosalicylic acid (5-ASA) treatment orally, subjects must be on a stable dose for at least 1 week prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 12.
21. Treatment with another investigational product or approved therapy for investigational use within 8 weeks prior to Week 0.
22. Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins within 12 weeks prior to Week 0.
23. Treatment with an anti-TNF agent (including anti-TNF agents as part of an investigational study)
24. Treatment with methotrexate, cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 4 weeks prior to Week 0.
25. Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative Colitis
MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis

Intervention(s)

Product Name: Baminercept
Product Code: BG9924
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: BG9924
Other descriptive name: Baminercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective of this study is to assess the potential of baminercept as an agent for inducing clinical response at Week 12 in subjects with moderate to severe UC.

Secondary Objective: To assess the potential of baminercept for achieving clinical remission at Week 24 in this study population.
To determine the safety and tolerability of baminercept in this study population.

Primary end point(s): Clinical response at Week 12 will be evaluated by the proportion of subjects with a decrease from baseline in the Total Mayo Score by at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 0 or 1

Secondary ID(s)

104UC201