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

Conditions: lcerative colitis
MedDRA version: 14.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-000897-80-ES

Lead Sponsor: Genentech, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Objective: ? To evaluate the safety and tolerability of rhuMAb Beta7 over a<br>treatment period of 10 weeks and a follow-up period of 18 weeks<br>? To characterize the pharmacokinetic (PK) and immunogenicity (antitherapeutic antibody/ATA profile) of rhuMAb Beta7 when administered SC across dose levels;Primary end point(s): Proportion of patients in clinical remission at Week 10.;Timepoint(s) of evaluation of this end point: Week 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) The proportion of patients with clinical response at Week 6 and Week 10<br>2) The proportion of patients in clinical remission at Week 6<br>3) The proportion of patients who achieve an endoscopic score and<br>rectal bleeding score of 0;Timepoint(s) of evaluation of this end point: 1) Week 6 and Week 10<br>2) Week 6<br>3) Week 10

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