Eligibility criteria
Condition
Ulcerative Colitis
Sex
Females and Males
Age
18-75 years
Inclusion criteria
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- Male or female subjects between ≥ 18 and ≤ 75 years of age at the time of informed consent
- Male subjects able to father children and female subjects of childbearing potential must agree to use two highly effective methods of contraception throughout the study and until the Week 26 visit
- Diagnosis of ulcerative colitis (UC) for ≥ 4 months
- Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for ulcerative colitis such as: Steroids; Immunosuppressants (AZA, 6-MP, or MTX); Anti TNF inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab).
- Subjects currently receiving the following treatment are eligible provided they have been on stable doses of Oral 5
- ADA or sulfasalazine for at least 4 weeks prior to baseline; oral corticosteroids stable dose for at least 2 weeks prior to baseline; 6-MP or AZA stable dose for 8 weeks prior to baseline.
Exclusion criteria
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- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn's Disease. Subjects with clinical findings suggestive of Crohn's disease (eg, fistulae, granulomas on biopsy) are also excluded.
- Subjects with colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known colonic stricture, history of colonic or small bowel stoma, history of colonic or small bowel obstruction or resection
- Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening
- Presence of a transplanted organ
- Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence);
- Acute coronary syndrome (eg., myocardial infarction, unstable angina pectoris); - Any history of cerebrovascular disease within 24 weeks before screening;
- Class III or Class IV heart failure
- Prior evidence of liver injury or toxicity due to methotrexate
- Subjects receiving the following therapies within the designated time period:
- > 9 mg/day of oral budesonide or >20 mg/day prednisone or equivalent within 2 weeks prior to baseline
- IV, IM (parenteral), or topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline
- Biologics including anti-TNF inhibitors as described: Infliximab, Adalimumab, or Golimumab within 8 weeks prior to baseline
- Anti-integrin inhibitors (eg, vedolizumab) within 12 weeks prior to baseline
- Other investigational procedures or products, or live attenuated vaccine within 30 days prior to baseline.
- Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse.
Trial Details
Administration
Intravenous injections
Placebo
A placebo is not used in this trial
Duration
Treatment: 12 weeks
Follow up: 3 months
Screening: Up to 6 weeks
Site Visits
Treatment: 7 visits
Follow up: 5 visits
Screening: Up to 2 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned