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Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborator:
Drais Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Telsar Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01612039
First received: June 1, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.

The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.


Condition Intervention Phase
Ulcerative Colitis
Drug: ASP3291
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Telsar Pharma Inc.:

Primary Outcome Measures:
  • Change from baseline (Visit 2) to Week 8 (Visit 7) in Modified Baron Score [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with Modified Baron Score of 0 or 1 at Week 8 (Visit 7) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change in Ulcerative Colitis Clinical Score of >3 [ Time Frame: Basline to Week 8 ] [ Designated as safety issue: No ]
  • Ulcerative Colitis Clinical Score stool frequency and rectal bleeding score of 0 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP3291 Drug: ASP3291
Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks
Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of ulcerative colitis by endoscopy and histology consistent with diagnosis
  • Must be able to provide informed consent
  • Has a Modified Baron Score of at least 2 (as determined by the investigator) at 15 cm or more from the anal verge as assessed during the screening period
  • Has an Ulcerative Colitis Clinical Score (UCCS) of at least 4, with a stool frequency and rectal bleeding score of at least 1 as assessed during the screening period
  • If female, is at least 2 years postmenopausal, surgically sterile per documentation provided by a medical professional, agrees to sexual abstinence, or uses two approved highly effective methods of birth control during the study period and for 30 days after the last dose of study drug
  • If male, agrees to sexual abstinence or to use two highly effective methods of birth control during the study period and for 90 days after last dose; agrees to not donate sperm during the study period and for 90 days after last dose
  • Willing and able to comply with the study requirements

Exclusion Criteria:

  • Has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study
  • Has severe Ulcerative Colitis as defined by an average bloody stool frequency of >6 per day and at least one of the following:

    • Resting heart rate >90 bpm
    • Oral temperature of >38°C (>100.4°F)
    • Hemoglobin of <10.5 g/dL
  • Has has undergone previous resective colonic surgery
  • Has a significant or immediate risk for toxic megacolon
  • Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
  • Has an extension of disease limited to ulcerative proctitis (i.e., disease extension less than 15 cm from the anal verge)
  • Has an active peptic ulcer disease based on medical history
  • Shows a stool culture positive for enteric pathogens during the screening period
  • Had previous treatment with tumor necrosis factor-α (TNF α) inhibitors
  • Had treatment with rectal corticosteroid within 2 weeks before Day -2
  • Has active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) at screening
  • Has an estimated glomerular filtration rate (using Cockroft-Gault formula corrected for body surface area) of <60 mL/min at screening
  • Known history of human immunodeficiency virus antibody
  • History of severe allergic or anaphylactic reactions requiring medical attention
  • Has participated in another investigational study within 30 days before Visit 3
  • History of drug or alcohol abuse in the past 2 years
  • Has previously participated in a study with ASP3291
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612039

Sponsors and Collaborators
Telsar Pharma Inc.
Drais Pharmaceuticals, Inc.
Investigators
Study Director: Robert Schinagl, Ph.D. Drais Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Telsar Pharma Inc.
ClinicalTrials.gov Identifier: NCT01612039     History of Changes
Other Study ID Numbers: 3291-CL-0004
Study First Received: June 1, 2012
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health
Serbia: Medicines and Medicinal Devices of Serbia

Keywords provided by Telsar Pharma Inc.:
ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014