A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01240915
• Date of registration: 10/11/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
• Scientific title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis
• Date of first enrolment: February 2011
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01240915
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Germany, Hungary, Italy, Slovakia, Sweden, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects must have a documented diagnosis of ulcerative colitis at least 6 months
prior to screening.

- Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.

- Subjects must have Modified Baron endoscopic score of at least 2 determined within 7
days of first dosing.

- Subjects must have failed or be intolerant (as determined by the investigator) of at
least one of the following treatments for UC: Oral corticosteroids, azathioprine or
6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab
or adalimumab.

- Subjects must be on stable steroid doses.

Exclusion Criteria:

- Subjects who have abnormal organ and marrow function.

- Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of
Crohn's disease.

- Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.

- Subjects receiving or who are expected to receive Infliximab or other biologic
treatment within 8 weeks of the Day 1 study visit.

- Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or
tacrolimus within 4 weeks of the Day 1 study visit.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: placebo

Drug: MultiStem low dose

Drug: MultiStem high dose

Primary Outcome(s)

Number of Treatment-Emergent AEs by Severity [Time Frame: Baseline up to Week 52]

Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 [Time Frame: Baseline and Week 8]

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 52]

Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 [Time Frame: Baseline and Week 4]

Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8 [Time Frame: Baseline and Week 8]

Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) [Time Frame: Baseline up to Week 52]

Secondary Outcome(s)

Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 [Time Frame: Baseline, Weeks 4, 8, 12 and 16]

Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 [Time Frame: Baseline and Week 16]

Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 [Time Frame: Baseline, Weeks 4, 8, 12 and 16]

Number of Participants With Laboratory Test Abnormalities [Time Frame: Baseline up to Week 24]

Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 [Time Frame: Baseline, Weeks 4, 8, 12 and 16]

Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 [Time Frame: Week 4, 8, 12 and 16]

Percentage of Participants in Clinical Response at Week 8 [Time Frame: Week 8]

Change From Baseline in Total Mayo Scores at Week 8 [Time Frame: Baseline, Week 8]

Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 [Time Frame: Baseline, Weeks 4, 8, 12 and 16]

Number of Participants With Potentially Clinically Significant Vital Signs Findings [Time Frame: Baseline up to Week 52]

Percentage of Participants in Clinical Remission at Week 8 [Time Frame: Week 8]

Percentage of Participants in Endoscopic Remission at Week 8 [Time Frame: Week 8]

Change From Baseline in Biopsy Histology Scores at Week 8 [Time Frame: Baseline and Week 8]

Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 [Time Frame: Baseline, Week 12, Week 16]

Percentage of Participants With Endoscopic Response at Week 8 [Time Frame: Week 8]

Secondary ID(s)

2010-022766-27

B3041001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Athersys, Inc

Results

• Results available: Yes
• Date Posted: 23/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01240915