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Also known as MDX-1100 (anti-CXCL10 human monoclonal antibody)
MDX-1100 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | sterile saline for injection |
| 1 | EXPERIMENTAL | MDX-1100 for injection |
| MDX-1100 | EXPERIMENTAL | MDX-1100 10 mg/kg administered i.v. over 60 minutes on days 1, 15, 29, 43, 57, and 71 |
| Placebo | PLACEBO_COMPARATOR | Placebo (saline) administered i.v. over 60 minutes on days 1, 15, 29, 43, 57, and 71 |
| Name | Type | Description |
|---|---|---|
| sterile saline for injection | BIOLOGICAL | 10mg/kg/dose sterile saline injected every other week for a total of 4 doses |
| MDX-1100 | BIOLOGICAL | 10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses |
| Placebo | DRUG | Placebo |
| MDX-1100 (anti-CXCL10 human monoclonal antibody) | DRUG | Patients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100. |
Inclusion Criteria: * Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP); * Mayo score of 6 to 10 points with moderate to severe disease on endoscopy * Subjects on the following medications; 1. prednisolone ≤ 20 mg daily (or equivalent) (dose ...
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MDX-1100 is an investigational human monoclonal antibody that targets CXCL10, a chemokine involved in immune cell trafficking. It was developed by Bristol-Myers Squibb for inflammatory conditions. It is also known as an anti-CXCL10 human monoclonal antibody. The drug has been studied in rheumatoid arthritis and ulcerative colitis but is not approved.
MDX-1100 was studied for the treatment of rheumatoid arthritis and ulcerative colitis. In rheumatoid arthritis, it was evaluated in combination with methotrexate. In ulcerative colitis, it was tested as a monotherapy. These were investigational uses in clinical trials, and the drug is not approved for any indication.
MDX-1100 targets CXCL10, also known as IP-10, a chemokine that attracts activated T cells and other immune cells to sites of inflammation. By binding to CXCL10, the antibody is designed to block this chemokine-mediated immune cell recruitment. This mechanism was being explored for inflammatory diseases such as rheumatoid arthritis and ulcerative colitis.
MDX-1100 was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical trials for the drug in rheumatoid arthritis and ulcerative colitis.
MDX-1100 is in Phase 2 development. Two Phase 2 trials have been completed: one in rheumatoid arthritis and one in ulcerative colitis. A Phase 1 dose-escalation study in ulcerative colitis has also been completed. The drug is investigational and has not been approved by the FDA.
MDX-1100 has been evaluated in three completed clinical trials. NCT01017367 was a Phase 2 study in rheumatoid arthritis testing MDX-1100 with methotrexate. NCT00656890 was a Phase 2 trial in ulcerative colitis. NCT00295282 was a Phase 1 dose-escalation study in ulcerative colitis. All trials have been completed.