Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: BL-7040
Intervention description: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; IBD

Summary:

      The objective of the proposed study is to determine whether BL-7040 demonstrates clinical
      efficacy in patients with inflammatory bowel disease (IBD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age 18 to 70.

          2. Moderately active ulcerative colitis as defined by Mayo score of ≥ 5 and ≤ 9 within 9
             days of first day of study treatment.

          3. Diagnosis of ulcerative colitis ≥ 3 months prior to study entry.

          4. Endoscopic sub-score of ≥ 2 and rectal bleeding sub-score of ≥ 1 on the Mayo score and
             endoscopic evidence of disease activity a minimum of 20 cm from the anal verge,
             determined within 9 days of first day of study treatment.

          5. Female patients must have a negative serum pregnancy test at screening and be willing
             and able to use a medically acceptable method of birth control or declare that they
             are abstaining from sexual intercourse, from the screening visit through the study
             termination visit or be surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as
             women with menstruation cessation for 12 consecutive months prior to signing of the
             informed consent form.

          6. Ability and willingness to understand and comply with study procedures and to give
             written informed consent prior to enrollment

        Exclusion Criteria:

          1. Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease.

          2. Subjects with ulcerative proctitis.

          3. A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon.

          4. Evidence of bowel infection.

          5. Body temperature ≥ 38°C at screening.

          6. Evidence of abdominal abscess at the initial screening visit.

          7. Extensive colonic resection, subtotal or total colectomy.

          8. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

          9. Receiving non-permitted IBD therapies

         10. History of or current peptic ulcer disease.

         11. Pregnant or lactating women.

         12. Chronic hepatitis B or C infection or HIV seropositivity.

         13. Current or recent history of severe, progressive, or uncontrolled renal, hepatic,
             hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or
             neurological disease.

         14. Drug or alcohol abuse (by history).

         15. Patients participating in any other clinical trials.

         16. Patients with inability to communicate well with the Investigators and staff (i.e.,
             language problem, poor mental development or impaired cerebral function).