A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

• Register: EUCTR
• Last refreshed on: 15 April 2013
• Main ID: EUCTR2011-000897-80-HU
• Date of registration: 07/09/2011
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease
• Scientific title: PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
• Date of first enrolment: 05/09/2011
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000897-80
• 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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Australia, Canada, Czech Republic, Germany, Hungary, Israel, New Zealand, Spain, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Able and willing to provide written informed consent
- 18-75 years of age
- Males and females with reproductive potential must be willing to use a highly effective method of contraception (e.g., hormonal contraceptive [oral or patch], vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half lives) after the final dose of the study drug.
- Diagnosis of moderate to severe UC outpatient with an MCS of >=5, including an endoscopy subscore >= 2; a rectal bleeding subscore >= 1 (see Appendix B); and disease activity a minimum of 25 cm from the anal verge

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Moderate to severe anemia (hemoglobin < 9 g/dL)
- A history or evidence of colonic mucosal dysplasia
- Pregnant or lactating
- Lack of peripheral venous access
- Inability to comply with study protocol, in the opinion of the investigator
- Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- History of malignancy except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
- Impaired renal function (serum creatinine > 1.5 x upper limit of normal [ULN])
- Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis (serum transaminases > 2.5 x ULN, alkaline phosphatase > 2.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant). If the patient has a diagnosis of primary sclerosing cholangitis, serum transaminases > 3 x ULN, alkaline phosphatase > 3 x ULN, or abnormalities in synthetic liver function tests (total bilirubin > 1.5 x ULN) judged by the investigator to be clinically significant.
- Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
- History of any opportunistic infections within 12 weeks prior to initiation of study treatment
- Demyelinating disease or history of PML
- Any current or recent (within 4 weeks prior to initiation of study treatment) signs or symptoms of infection
- Received any investigational treatment within 12 weeks prior to initiation of study treatment (or within 5 half lives of the investigational product, whichever is greater)
- Previous exposure to rhuMAb Beta7
- History of severe allergic or anaphylactic reactions to chimeric, human or humanized antibodies or fusion proteins


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

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 14.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
Current Sponsor code: PRO145223 (RO5490261)
Other descriptive name: rhuMAb Beta7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: • To evaluate the safety and tolerability of rhuMAb Beta7 over a treatment period of 10 weeks and a follow-up period of 18 weeks
• To characterize the pharmacokinetic (PK) and immunogenicity (anti-therapeutic antibody/ATA profile) of rhuMAb Beta7 when administered SC across dose levels

Timepoint(s) of evaluation of this end point: Week 10

Primary end point(s): Proportion of patients in clinical remission at Week 10.

Main Objective: The primary objective of this study is to evaluate the efficacy of different doses of rhuMAb Beta7 compared with placebo in patients with moderate to severe UC.

Secondary Outcome(s)

Secondary end point(s): 1) The proportion of patients with clinical response at Week 6 and Week 10
2) The proportion of patients in clinical remission at Week 6
3) The proportion of patients who achieve an endoscopic score and rectal bleeding score of 0

Timepoint(s) of evaluation of this end point: 1) Week 6 and Week 10
2) Week 6
3) Week 10

Secondary ID(s)

2011-000897-80-CZ

ABS4986g

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffmann-La Roche