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rhuMAb Beta7

Phase 2

Ulcerative Colitis | Small molecule | Gastrointestinal |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment172

FDA Designations

No designations recorded

Clinical trial landscape

rhuMAb Beta7 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01336465Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative ColitisUlcerative Colitis
COMPLETED124 Analytics
PHASE2COMPLETED
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Week 10
Incidence and nature of laboratory abnormalities
Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Through study completion or early study discontinuation

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
rhuMAb Beta7EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
1EXPERIMENTAL -

Interventions

NameTypeDescription
placeboDRUGRepeating subcutaneous injection
rhuMAb Beta7DRUGRepeating subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites51

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 his...

Countries:United StatesAustraliaBelgiumCanadaCzechiaGermanyHungaryIsraelNew ZealandSpainUnited KingdomNetherlands
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Frequently asked questions about rhuMAb Beta7

What is rhuMAb Beta7 used for?

rhuMAb Beta7 is an investigational drug being studied for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. It has been evaluated in clinical trials for patients with moderate to severe ulcerative colitis. The drug is still in clinical development and has not been approved by regulatory authorities.

Who makes rhuMAb Beta7?

rhuMAb Beta7 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company has conducted clinical trials to evaluate the safety and efficacy of rhuMAb Beta7 in patients with ulcerative colitis.

What phase is rhuMAb Beta7 in?

rhuMAb Beta7 has completed Phase 2 clinical trials for ulcerative colitis. The drug is investigational and remains in clinical development. It has not received regulatory approval. Two clinical trials have been completed, including a Phase 1 study and a Phase 2 study, with a total of 172 participants enrolled.

What clinical trials is rhuMAb Beta7 in?

rhuMAb Beta7 has been studied in two completed clinical trials. NCT00694980 was a Phase 1 study assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity in 48 patients with ulcerative colitis. NCT01336465 was a Phase 2 study evaluating efficacy and safety in 124 patients with moderate to severe ulcerative colitis.

Is rhuMAb Beta7 the same as etrolizumab?

rhuMAb Beta7 is also known as etrolizumab, a humanized monoclonal antibody targeting the beta7 integrin. It has been investigated for the treatment of ulcerative colitis. The drug is being developed by Roche Holding AG and has completed Phase 2 clinical trials, but it remains investigational and is not yet approved.