Ulcerative colitis MedDRA version: 14.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
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:
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: - Moderate to severe anemia (hemoglobin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 ;Primary end point(s): Proportion of patients in clinical remission at Week 10. ;Timepoint(s) of evaluation of this end point: Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Belgium, Canada, Czech Republic, Germany, Hungary, Israel, New Zealand, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed