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MEDI7183 low dose

Phase 2

Ulcerative Colitis | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Jul 5, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

MEDI7183 low dose · 1 trial · 1 indication

Phase 2 1
NCT01959165MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis PatientsUlcerative Colitis
COMPLETED44 Analytics
PHASE2COMPLETED
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Remission at Week 8
8 weeks

Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.

Secondary Endpoints

Number of Participants With Response at Week 8
8 weeks
Number of Participants With Mucosal Healing at Week 8
8 weeks
Number of Participants With Response at Week 12
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI7183 dose 1EXPERIMENTALDouble blinded
MEDI7183 dose 2EXPERIMENTALDouble blinded
MEDI7183 dose 3EXPERIMENTALDouble blinded
PlaceboPLACEBO_COMPARATORDouble blinded

Interventions

NameTypeDescription
MEDI7183 low doseDRUGMEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
MEDI7183 medium doseDRUGMEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
MEDI7183 high doseDRUGMEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
Matching PlaceboDRUGPlacebo will be administered by SC on Day 1, Week 2,4, and 8
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report * Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy...

Countries:Japan
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Frequently asked questions about MEDI7183 low dose

What is MEDI7183 low dose used for?

MEDI7183 low dose is an investigational small molecule being studied for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes MEDI7183 low dose?

MEDI7183 low dose is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is MEDI7183 low dose in?

MEDI7183 low dose is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication.

What clinical trials is MEDI7183 low dose in?

MEDI7183 low dose has been studied in one completed Phase 2 clinical trial, identified as NCT01959165, which evaluated its safety and efficacy in Japanese patients with ulcerative colitis. The trial enrolled 44 participants.

Is MEDI7183 low dose the same as MEDI7183?

MEDI7183 low dose is a specific dosage form of the investigational drug MEDI7183. The low dose designation refers to the particular dose level being evaluated in clinical studies for ulcerative colitis.