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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Lille Lille France
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Ospedale San Raffaele S.r.l. Milan Italy
Gastromed Sp. z o.o. Torun Poland
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Clinexpert Kft. Budapest Hungary
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Clinfan Kft. Szekszard Hungary
Centre Hospitalier Universitaire De Toulouse Toulouse France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Medrise Sp. z o.o. Lublin Poland
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Deutsches Herzzentrum Berlin Berlin Germany
San Camillo Forlanini Hospital Rome Italy
Centrum Medyczne Oporow Wroclaw Poland
Eugastro GmbH Leipzig Germany
Endoskopia Sp. z o.o. Sopot Poland
Hopital Saint Eloi Montpellier France
Uniklinikum Salzburg Salzburg Austria
Medical Centre Hungarian Defence Forces Budapest Hungary
Piotr Walczak Gabinet Endoskopii Przewodu Pokarmowego Cracow Poland
Cvjk Di Nrrlx Vandoeuvre Les Nancy France
Sfnkhsz Cuqhntp Muxaqrtp Sfz z okec Poznan Poland
Upkbfnjgnb Mlney Ghkpsyb Oz Combqmxie Catanzaro Italy
Izfwkjsn db Cxraqlxjhvej Heucmqzmsma Umnyrhtzteilx dk Spxih Ecyjfsb (qlukjba Saint Priest En Jarez France
Wjh Wckysa Iks Pbmoc Pkijrovt Kxerohh Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
02.10.2023
Belgium Belgium
Recruiting
02.10.2023
France France
Recruiting
02.10.2023
Germany Germany
Recruiting
02.10.2023
Hungary Hungary
Recruiting
02.10.2023
Italy Italy
Recruiting
02.10.2023
Poland Poland
Recruiting
02.10.2023

Trial locations

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.

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 ID:
2022-501119-14-01
Protocol code:
GS-US-457-6411
Trial Phase:
Therapeutic exploratory (Phase II)

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