Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01039597
• Date of registration: 23/12/2009
• Prospective Registration: No
• Primary sponsor: Ore Pharmaceuticals, Inc.
• Public title: Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis
• Date of first enrolment: December 2009
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01039597
• 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
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada, India

Contacts

• Name: John F Reinhard, Ph.D.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has a documented diagnosis of mild to moderate Ulcerative Colitis, as
demonstrated clinically and by endoscopy at Visit 2.

2. Baron score greater than or equal to 2 at baseline.

3. Truelove-Witt (modified) score of 14 or less.

4. At least 6 months duration of disease

5. At baseline the subject should have either stable disease or stable disease requiring
5-ASA treatment

6. If on a 5-ASA treatment, subject must have been on stable dose for at least two weeks
prior to screening and is expected to continue on that dose until the study is
completed

7. Subject has normally functioning major organ systems (aside from gastrointestinal
tract) as indicated by medical history, vital signs, physical exam and clinical
laboratories (including hematology, coagulation, chemistries and urinalysis).

8. Male or female subjects 18-70 years old

9. Subject has provided voluntary written informed consent to participate in this study.

10. Subject may be of child-bearing potential, but is not pregnant, nursing, or planning
a pregnancy for the duration of the study and has a negative pregnancy test prior to
enrollment.

11. Subject agrees to use a medically-acceptable form of contraception from screening
through 30 days after the final dose of study drug. Female partners of male subjects
enrolled into this study are also recommended to use an acceptable method of birth
control. Males must agree to not donate sperm during the entire study and for 90
days after the last dose of study drug.

Exclusion Criteria:

1. A clinically significant medical history, medical finding or an ongoing medical or
psychiatric condition which, in the opinion of the Investigator, could jeopardize the
safety of the subject, impact the validity of the study results, or interfere with
the completion of treatment according to this protocol.

2. Subject has an ALT or serum creatinine greater than 1.5 times the upper limit of
normal range for the reference lab at screening.

3. Subject who, in the opinion of the investigator, is febrile at screening.

4. Subject had used the following treatments for IBD: steroids or any or biologic
immunomodulators or any topical treatments (e.g. enemas) within the last 4 weeks
prior to baseline, immunosuppressants or antimetabolites within the preceding 6
weeks, antibiotic use within the previous 7 days or chronic use of any
anti-inflammatory drugs (except aminosalicylates) within 7 days.

5. History of illicit drug abuse or positive urine screen for drugs of abuse or history
of alcohol abuse if acknowledged at the screening visit or noted in the subject's
medical record at screening.

6. Subject has a positive blood screen for HIV, Hepatitis B (HBsAg), or Hepatitis C.

7. Subject has evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis,
Giardia lamblia by stool examination of at screening.

8. Subject has evidence for gastrointestinal parasites as per stool ova and parasites
testing at screening.

9. Subject has evidence of tuberculosis by blood interferon gamma release assay at
screening.

10. Any uncontrolled, intercurrent illness (e.g., active infection).

11. History of gastrointestinal cancer.

12. Abdominal surgery or any major surgery within the preceding 28 days of the screening
visit.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Mild to Moderate Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: ORE1001

Primary Outcome(s)

The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events [Time Frame: 6 Week]

Secondary Outcome(s)

Clinical remission [Time Frame: Week 6]

Change in the modified Baron Score from Baseline to Week 6 [Time Frame: 6 Week]

Change in the partial Mayo Score fom baseline [Time Frame: 6 week]

Riley Acute Inflammation Scale (histology) [Time Frame: 6 week]

Calprotectin concentrations [Time Frame: 6 week]

Change in the Ulcerative Colitis Clinical Score from Baseline [Time Frame: 6 Week]

Secondary ID(s)

ORX102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors