Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Conditions

Ulcerative Colitis

Brief summary

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

B Gutierrez Becker, E Giuffrida, M Mangia, Filippo Arcadu, V Whitehill et al. (11 authors)

Journal of Crohn s and Colitis2021-05-01

10.1093/ecco-jcc/jjab076.198

P035 ETROLIZUMAB TREATMENT MODULATES SOLUBLE MADCAM-1 LEVELS IN SERUM IN PATIENTS WITH CROHN’S DISEASE

William J. Sandborn, Julián Panés, Franklin Fuh, Rich Erickson, Rhian Jacob et al. (8 authors)

Inflammatory Bowel Diseases2019-02-01

10.1093/ibd/izy393.040

P395 Etrolizumab demonstrated no difference among doses in symptomatic and endoscopic-based evaluation of remission in anti-TNF-α-naïve patients in a post-hoc analysis of the phase 2 ulcerative colitis trial (EUCALYPTUS)

William J. Sandborn, Stefan Schreiber, Meina Tang, Amanda R. Tatro, Young S. Oh et al. (6 authors)

Journal of Crohn s and Colitis2017-01-263 citations

10.1093/ecco-jcc/jjx002.520

Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial.

Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P.

2014-05-09337 citations

10.1016/s0140-6736(14)60661-9

Interventions

DRUGplacebo

Repeating subcutaneous injection

DRUGrhuMAb Beta7

Repeating subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Diagnosis of moderate to severe ulcerative colitis outpatient * Disease duration at time of screening of \>/= 12 weeks

Exclusion criteria

* Extensive colonic resection or subtotal or total colectomy * Presence of an ileostomy or colostomy * Moderate to severe anemia * A history or evidence of colonic mucosal dysplasia * Pregnant or lactating * Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders * Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block * Poorly controlled diabetes * Impaired renal function * Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis * Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV) * Positive screening test for latent mycobacterium tuberculosis (TB) infection * Demyelinating disease * Received any investigational treatment within 12 weeks prior to initiation of study treatment * Previous exposure to rhuMAb Beta7

Design outcomes

Primary

Measure	Time frame
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point	Week 10

Secondary

Measure	Time frame
Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1	Week 6 and Week 10
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point	Week 6
Proportion of patients with endoscopic score and rectal bleeding score of 0	Week 6 and Week 10

Countries

Australia, Belgium, Canada, Czechia, Germany, Hungary, Israel, New Zealand, Spain, United Kingdom, United States

Outcome results

None listed