A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis

Phase 2

Completed

Conditions: inflammation of the colon
10018027

Registration Number: NL-OMON40782

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1. Subjects must be a man or woman 18 years or older, inlusive
2. Have a clinical diagnosis of UC at least 3 months prior to screening
3. Have a clinical daignosis of moderately to severely active ulcerative colitis (UC), defined as a baseline (Week 0) Mayo score of 6 to 12 (inclusive),
4. Must have a screening endoscopy with a > <= 2 endoscopy sub score of the Mayo score as
determined by a central reading of the video endoscopy
5. Prior or current medication for UC must be as per protocol (page 25-26)
6. Prior to the screening endoscopy or the earliest entry in the Mayo diary card (whichever of these 2 events comes first) the following conditions must be met:
- per protocol requirements for treatment with 6- mercaptopurine, azathioprine, or methotrexate;
- per protocol requirements for treatment with oral 5-aminosalicylate or oral corticosteroids;
- treatment must have been discontinued for at least 2 weeks for rectal corticosteroids, rectal 5-aminosalicylate compounds, parenteral corticosteroids, total parenteral nutrition, pentoxifylline, thalidomide or related agents, and antibiotics for the treatment of UC;
- treatment with 6-thioguanine, mercaptopurine and azathioprine must have been discontinued for at least 4 weeks
7. Must have had a colonoscopy as per the time frame described in the protocol for the following: extensive colitis for > <= 8 years; disease limited to the left side of the colon for > <= 10 years; participants > <= 45 years of age to assess for the presence of adenomatous polyps
Must meet the tuberculosis and hepatitis B virus screening criteria as defined in the protocol

Exclusion Criteria

The presence of any of the following:
1. Have severe extensive colitis;
2. UC limited to the rectum only or to <20 cm of the colon;
3. a stoma;
4. a fistula (or history of a fistula);
5. symptomatic colonic or small bowel obstruction;
6. adenomatous colonic polyps (or history of adenomatous colonic polyps); or indeterminate colitis or clinical findings suggestive of Crohn's disease
7. History of extensive colonic resection (eg, less than 30 cm of colon remaining) or colonic mucosal dysplasia;
8. requires (or has required within the 2 months prior to screening) surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, intra abdominal or pancreatic abscess requiring surgical drainage
9. Have received the following concomitant or previous medical therapies: biologic therapy targeted at tumor necrosis factor alpha (eg, infliximab, adalimumab, golimumab, etanercept, certolizumab); natalizumab within 12 months of first golimumab administration; agents that deplete B- or T-cells (eg, rituximab, alemtuzumab, or visilizumab) within 12 months of
first golimumab administration, or continue to manifest depletion of Bor T-cells more than 12 months after completion of therapy with lymphocyte depleting agents; cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to first administration of
golimumab; vedolizumab within 8 weeks prior to first golimumab administration; apheresis (ie, Adacolumn apheresis) within 2 weeks prior to first administration of golimumab; any investigational drug within 4 weeks prior to first administration of golimumab or within 5
half-lives of the investigational agent, whichever is longer; or oral corticosteroids at a dose of greater than 40 mg of prednisone or its equivalent per day
10. Have received, or are expected to receive, any live viral or bacterial vaccination within 8 weeks (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of golimumab or have had Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
11. History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results.