MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: MEDI7183 low dose; Drug: Matching Placebo; Drug: MEDI7183 high dose; Drug: MEDI7183 medium dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959165

D5172C00001

Details and patient eligibility

About

This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 score ≥ 2 during screening period
• Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc.

Exclusion criteria

• Disease limited to the rectum
• Toxic megacolon
• Crohn's Disease
• History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
• Planned bowel surgery within 12 weeks from Visit 2
• Stool positive for C. difficile toxin at screening
• Primary Sclerosing Cholangitis
• History of gastrointestinal surgery within 8 weeks of Visit 2
• Any uncontrolled or clinically significant systemic disease
• Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion
• Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 4 patient groups, including a placebo group

MEDI7183 dose 1

Experimental group

Description:

Double blinded

Treatment:

Drug: MEDI7183 low dose

MEDI7183 dose 2

Experimental group

Description:

Double blinded

Treatment:

Drug: MEDI7183 medium dose

MEDI7183 dose 3

Experimental group

Description:

Double blinded

Treatment:

Drug: MEDI7183 high dose

Placebo

Placebo Comparator group

Description:

Double blinded

Treatment:

Drug: Matching Placebo