Ulcerative ColitisPhase 2NCT01959165

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

A Phase 2 study testing MEDI7183 low dose, MEDI7183 medium dose and MEDI7183 high dose in people with Ulcerative Colitis, run by AstraZeneca at 23 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: MEDI7183 low dose, MEDI7183 medium dose and MEDI7183 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 23 sitesJapan
Study dates: 21 Nov 2013to 10 Apr 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Japan23 sites

Research Site
Chikushino-shi, 818-8502
Research Site
Fujiidera-shi, 583-0027
Research Site
Fukuyama-shi, 720-8520
Research Site
Hamamatsu, 432-8061
Research Site
Kagoshima, 892-0846
Research Site
Kamakura-shi, 247-0056
Research Site
Kyoto, 606-8507
Research Site
Kyoto, 612-8555
Research Site
Minatoku, 108-8642
Research Site
Morioka, 020-8505
Research Site
Niigata, 950-1104
Research Site
Nishinomiya-shi, 663-8501
Research Site
Ōita, 870-0033
Research Site
Osaka, 545-8586
Research Site
Sakura-shi, 285-8741
Research Site
Sapporo, 004-0041
Research Site
Sapporo, 060-0033
Research Site
Sapporo, 065-0033
Research Site
Sayama-shi, 350-1305
Research Site
Shinagawa-ku, 141-0022
Research Site
Shinjuku-ku, 169-0073
Research Site
Yokkaichi-shi, 510-0016
Research Site
Yokohama, 236-0004

Other trials in Japan

About this study

Conditions: Ulcerative Colitis
Being tested: MEDI7183 low dose, MEDI7183 medium dose, MEDI7183 high dose, Matching Placebo
Keywords: Ulcerative Colitis, Japanese, subcutaneously
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI7183 low doseDrug
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
MEDI7183 medium doseDrug
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
MEDI7183 high doseDrug
MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
Matching PlaceboDrug
Placebo will be administered by SC on Day 1, Week 2,4, and 8

Study groups in NCT01959165
Study group	Role	What they receive
MEDI7183 dose 1	Experimental	Double blinded Receives: Drug: MEDI7183 low dose
MEDI7183 dose 2	Experimental	Double blinded Receives: Drug: MEDI7183 medium dose
MEDI7183 dose 3	Experimental	Double blinded Receives: Drug: MEDI7183 high dose
Placebo	Placebo comparator	Double blinded Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With 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.
Measured: 8 weeks

Secondary outcomes (3)

Number of Participants With 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.
Measured: 8 weeks
Number of Participants With Mucosal Healing at Week 8
Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
Measured: 8 weeks
Number of Participants With 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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 201310 Apr 2018

First posted9 Oct 2013 (estimated)
Study start21 Nov 2013
Primary completion11 Aug 2015
Study completion10 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01959165
Sponsor's protocol ID: D5172C00001
Status last verified: Apr 2019
First submitted: 8 Oct 2013
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
ClinicalTrials.gov ID: NCT01959165
Acronym / sponsor ID: D5172C00001
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, Japanese, subcutaneously
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Nov 2013 (actual)
Primary completion: 11 Aug 2015 (actual)
Study completion: 10 Apr 2018 (actual)
First posted: 9 Oct 2013 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
MEDI7183 dose 1	Experimental	Drug: MEDI7183 low doseDouble blinded
MEDI7183 dose 2	Experimental	Drug: MEDI7183 medium doseDouble blinded
MEDI7183 dose 3	Experimental	Drug: MEDI7183 high doseDouble blinded
Placebo	Placebo comparator	Drug: Matching PlaceboDouble blinded

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI7183 low doseMEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8	Drug	MEDI7183 dose 1
MEDI7183 medium doseMEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8	Drug	MEDI7183 dose 2
MEDI7183 high doseMEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8	Drug	MEDI7183 dose 3
Matching PlaceboPlacebo will be administered by SC on Day 1, Week 2,4, and 8	Drug	Placebo

Primary outcome

Number of Participants With Remission at Week 8
Time frame: 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.

3 secondary outcomes

Number of Participants With Response at Week 8
Time frame: 8 weeks
Number of Participants With Mucosal Healing at Week 8
Time frame: 8 weeks
Number of Participants With Response at Week 12
Time frame: 12 weeks

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	13	12
MEDI7183 21 mg	11	10
MEDI7183 70 mg	12	12
MEDI7183 210 mg	9	7

Primary outcome: Number of Participants With Remission at Week 8

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 13	MEDI7183 21 mg n = 10	MEDI7183 70 mg n = 12	MEDI7183 210 mg n = 9
Number of participants with Remission	0	1	2	1

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks for DB period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13
MEDI7183 21 mg	1 of 10 (10%)	6 of 10 (60%)	0 of 10
MEDI7183 70 mg	0 of 12 (0%)	6 of 12 (50%)	0 of 12
MEDI7183 210 mg	1 of 9 (11.1%)	3 of 9 (33.3%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ulcerative Colitis

Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
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RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
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Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshifumi Hibi, Director and Professor principal investigator

Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University

Ki Rito, Study Physician study director

AztraZeneca, Tokyo, Japan

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI7183 low dose, MEDI7183 medium dose and MEDI7183 high dose in people with Ulcerative Colitis, run by AstraZeneca at 23 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Remission at Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.