VELSIPITY clinical trial information and results

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The efficacy of VELSIPITY was studied in 495 people in two clinical trials

In a 3-month study:

221 On VELSIPITY

112 on placebo (a sugar pill)

  • Average age on VELSIPITY was 41 years
  • 41% female participants

In a 12-month study:

274 On VELSIPITY

134 on placebo (a sugar pill)

  • Average age on VELSIPITY was 41 years
  • 45% female participants

VELSIPITY was studied in adults with moderate to severe UC across 2 different clinical trials, one lasting 3 months and the other 1 year. These trials looked at the safety and efficacy of VELSIPITY in treating moderate to severe UC, including when therapies like 5-ASAs,* steroids, biologics, or JAK inhibitors weren’t working.

*5-ASAs are 5-aminosalicylic acid derivatives.

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A powerful, once-daily treatment for adults with moderate to severe ulcerative colitis.

of people on VELSIPITY achieved clinical remission† at 1 year vs placebo (7%) in the 12-month trial.
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Some people on VELSIPITY achieved clinical remission† in just 3 months

In the 12-month study, at 12 weeks:

In the 3 month study:

†Clinical remission means that the symptoms of the disease have improved or disappeared. During remission, you may experience fewer or no episodes of stool frequency and/or rectal bleeding. It's important to remember that remission doesn't mean you are cured, and you still need to follow your doctor's advice to help keep the disease under control and help prevent flare-ups.
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VELSIPITY works fast

Less frequent visits to the bathroom in 2 weeks

Some saw rapid relief from UC symptoms with less frequent visits to the bathroom at Week 2 versus placebo.

Some people taking VELSIPITY for 4 weeks saw less rectal bleeding versus placebo.

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Visible normalization of the colon lining at 1 year

Visible normalization means that those areas of the colon lining assessed show no visible signs of inflammation or show the disease appears inactive with endoscopy. Areas visually assessed may not represent improvement of the entire colon lining.

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as many people experienced visible normalization of the colon lining with VELSIPITY (26%) vs placebo (6%) at 1 year.

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Proven

Some saw remission‡ by Week 12 and Week 52

Fast-acting

Some saw improvements in stool frequency as early as 2 weeks and improvements in rectal bleeding by 4 weeks

Long-lasting steroid-free remission

100% of patients in clinical remission‡ with VELSIPITY at 1 year were also steroid-free

‡Patients in remission experienced fewer bowel movements and no rectal bleeding.
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SELECT IMPORTANT SAFETY INFORMATION

VELSIPITY should not be taken by patients with certain cardiac conditions such as prior heart attack, chest pain, stroke or ministroke, heart failure in the last 6 months, irregular or abnormal heartbeat.

VELSIPITY can cause serious side effects including infections (some life threatening), a slow heart rate known as bradyarrhythmia, liver problems, increased blood pressure, a vision problem called macular edema, certain types of skin cancer, swelling and narrowing of the blood vessels in your brain, or shortness of breath. See full Important Safety Information at the bottom of this page.

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Find out if VELSIPITY is appropriate for you

Learn About Safety Data
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