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MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

AstraZeneca logo

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

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

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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