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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

NCT ID

Therapeutic Area

MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8

MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8

Placebo will be administered by SC on Day 1, Week 2,4, and 8

Research Site

Remission rate defined as a total Mayo Score ≤ 2 points, and with no individual subscore > 1 point.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

duration of Ulcerative Colitis

Study Specific Characteristic

use of 5-aminosalicylates at baseline of double-blind phase

use of 5-aminosalicylates

use of oral corticosteroids at baseline of double blind phase

use of oral corticosteroids

use of immunomodulators at baseline of double blind phase

use of immunomodulators

any prior use of anti-TNF-a agents

In MEDI7183 21 mg arm, 11 patients were randomised, but 1 patient discontinued the study without any treatment. Therefore, this patient was excluded from all of the analyses in this study.

Remission at Week 8

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

All randomised participants who received at least one dose of investigational drug during the double-blind phase

Number of participants with remission at Week 8

Response at Week 8

Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1.

Number of participants with Response at Week 8

Mucosal healing at Week 8

Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.

Number of participants with Mucosal healing at Week 8

Response at Week 12

Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline.

Number of participants with Response at Week 12

Overall Study

Out of the 59 enrolled participants, 14 participapatients were not assigned to any arm. Out of these 14 participants, 13 participants did not meet the eligibility criteria and 1 participants withdrew the informed consent.

Nii Masahiro

Response rate assessed by total Mayo score.  Response is defined as decrease ≥ 3 points and 30% in total Mayo Score compared to baseline (Visit 1), and with an accompanying decrease in the subscore for rectal bleeding of ≥1 point or with an absolute subscore for rectal bleeding of 0 or 1

Mucosal healing rate at Week 8 defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1

Response at Week 12 assessed by PMS. Response is defined as reduction by ≥2 points and 25% in PMS compared to baseline (Visit 1)

Adverse events, serious adverse events, discontinuations of investigational product due to adverse events (DAEs), laboratory values and vital signs through 28 weeks after last dose of MEDI7183

Receptor Occupancy and memory CD4 α4β7 hi (CD4 circulating lymphocytes expressing high levels of α4β7-integrin) cell numbers over time

Arms	Assigned Interventions
Experimental: MEDI7183 dose 1 Double blinded	Drug: MEDI7183 low dose MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
Experimental: MEDI7183 dose 2 Double blinded	Drug: MEDI7183 medium dose MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
Experimental: MEDI7183 dose 3 Double blinded	Drug: MEDI7183 high dose MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
Placebo Comparator: Placebo Double blinded	Drug: Matching Placebo Placebo will be administered by SC on Day 1, Week 2,4, and 8

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator