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Study on the Effects of GS-5290 for Patients with Moderate to Severe Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract. The treatment being tested is a medication known as GS-5290, which is taken in the form of film-coated tablets. The study aims to evaluate how effective and safe this medication is for people with moderately to severely active ulcerative colitis.

Participants in the study will be randomly assigned to receive either the GS-5290 tablets or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The main goal is to see if the medication can help reduce the symptoms of ulcerative colitis by Week 12 of the study.

The study will last for a period of 64 weeks, during which participants will take the medication orally. The researchers will monitor the participants' health and symptoms throughout the study to assess the medication's impact. The study will also look at secondary outcomes, such as achieving clinical remission and improvements in the condition of the colon as seen through endoscopic examinations. The results will help determine if GS-5290 is a viable treatment option for those suffering from ulcerative colitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and confirming a diagnosis of ulcerative colitis through endoscopy and histology.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, GS-5290, or a placebo. This process is double-blinded, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Medication administration

    Participants take GS-5290 tablets orally. The dosage is either 300 mg or 150 mg, depending on the randomization group. The medication is taken daily for the duration of the study.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the participant's response to the treatment. This includes evaluating stool frequency, rectal bleeding, and endoscopic findings. These assessments occur periodically throughout the study.

  5. Step 5

    Evaluation at week 12

    At week 12, a comprehensive evaluation is performed to determine the clinical response. This involves measuring changes in the modified Mayo Clinic Score, focusing on stool frequency, rectal bleeding, and endoscopic findings.

  6. Step 6

    Study completion

    Upon completion of the study, participants undergo a final assessment to evaluate the overall effectiveness and safety of the treatment. This includes a review of any changes in symptoms and potential side effects.

Who can join the trial?

5 criteria

  • Participants must be assigned male at birth or be nonpregnant and nonlactating if assigned female at birth, and be between 18 to 75 years old at the time of the screening visit.
  • Participants must have been diagnosed with **Ulcerative Colitis (UC)** for at least 90 days before joining the study. This diagnosis should be confirmed by a procedure called **endoscopy** (a test where a doctor looks inside the colon) and **histology** (examining tissue samples) at any time in the past. The disease must affect at least 15 cm from the anal verge (the opening of the anus).
  • Participants should have **moderately to severely active UC**. This is determined during screening using a score called the **modified Mayo Clinic Score**, which is based on stool frequency, rectal bleeding, and endoscopic findings. The score should be between 5 to 9 points, with an endoscopic subscore of 2 to 3.
  • Participants must have a history of treatment for UC with approved therapies. They should have tried at least one advanced therapy but experienced failure (meaning the treatment did not work or stopped working) with no more than three different advanced therapy types.
  • If participants have had UC for 8 or more years, they must have had a **surveillance colonoscopy** (a test to check the colon) within the 24 months before screening.

Who cannot join the trial?

10 criteria

  • Patients with any other significant health condition that could interfere with the study.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have been diagnosed with a serious mental health condition.
  • Patients who are unable to comply with the study procedures or follow-up visits.
  • Patients who have received certain medications that could affect the study results.
  • Patients who have an active infection that requires treatment.
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Investigated drugs

GS-5290 is a medication being studied for its potential to help people with moderately to severely active ulcerative colitis. The trial aims to see if this medication can improve symptoms and achieve a clinical response by the 12th week of treatment.

What is already known about the treatment

GS-5290 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active ulcerative colitis. It is in the experimental phase, with ongoing research to determine its safety and efficacy. The main therapeutic indication for GS-5290 is ulcerative colitis, a chronic inflammatory condition of the colon. At the molecular level, GS-5290 works by modulating specific pathways involved in inflammation, aiming to reduce the symptoms and progression of the disease. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501119-14-01Protocol codeGS-US-457-6411Estimated enrolment176 patientsSponsorGilead Sciences Inc.

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