Study on GS-1427 for Adults with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying a condition called Ulcerative Colitis, which is a type of inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. The study is testing a new treatment called GS-1427, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective and safe GS-1427 is for adults with moderately to severely active Ulcerative Colitis.

Participants in the study will be randomly assigned to receive either the GS-1427 tablets or a placebo. The study will last for up to 52 weeks, with the main focus on the results at Week 12. During this time, participants will take the medication orally, and their health will be monitored closely to see how well the treatment works and to check for any side effects. The study aims to see if the treatment can help reduce symptoms and improve the condition of the digestive tract.

Throughout the study, researchers will look for improvements in symptoms such as stool frequency and rectal bleeding, as well as overall healing of the digestive tract. The study will also track any adverse events or changes in laboratory tests to ensure the safety of the participants. The ultimate goal is to find out if GS-1427 can provide a new and effective treatment option for people living with Ulcerative Colitis.

1 joining the study

Upon joining the study, participants are confirmed to have ulcerative colitis (UC) for at least 90 days. This is verified through previous endoscopy and histology records.

Participants must have a minimum disease extent of 15 cm from the anal verge and a moderately to severely active UC as determined by endoscopy during screening.

2 randomization and treatment initiation

Participants are randomly assigned to receive either the study medication GS-1427 or a placebo. The medication is administered orally in the form of film-coated tablets.

The dosage and frequency of GS-1427 are determined by the study protocol, which aims to evaluate different doses for efficacy and safety.

3 treatment duration

The treatment period lasts for 12 weeks. During this time, participants continue to take the assigned medication as per the study guidelines.

4 evaluation of clinical response

At the end of 12 weeks, the primary goal is to assess the clinical response. This is defined as a significant decrease in the modified Mayo Clinic Score (mMCS) and improvement in rectal bleeding scores.

Secondary evaluations include checking for any adverse events, clinical remission, and mucosal healing.

5 long-term follow-up

Participants may be monitored for up to 52 weeks to assess long-term clinical remission and safety outcomes.

The study aims to gather comprehensive data on the efficacy and safety of GS-1427 over an extended period.

Who Can Join the Study?

  • 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 that looks inside the colon) and histology (examining tissue samples under a microscope).
  • Participants must have UC affecting at least 15 centimeters of the colon, starting from the anal verge (the opening of the anus).
  • Participants must have moderately to severely active UC, which is determined by an endoscopy during the screening process. This is measured using a score called the modified Mayo Clinic Score (mMCS), which should be between 5 to 9 points, including an endoscopic subscore of at least 2.
  • Participants must have had an inadequate response, lost response, or been intolerant to at least one conventional UC treatment. These treatments include corticosteroids (a type of medication that reduces inflammation) and immunomodulators like azathioprine or 6-mercaptopurine.
  • Alternatively, participants must have had an inadequate response, lost response, or been intolerant to one or two advanced therapy mechanisms. These include:
    • Tumor necrosis factor-alpha inhibitors such as infliximab, adalimumab, golimumab, or their biosimilars.
    • Interleukin-12/23 inhibitors like ustekinumab.
    • Sphingosine 1-phosphate receptor modulators such as ozanimod.
    • Janus kinase inhibitors like tofacitinib, upadacitinib, or filgotinib.
  • Both male and female participants are eligible for the study.
  • The study includes participants from vulnerable populations.

Who Cannot Join the Study?

  • Patients who have a different condition than Ulcerative Colitis (UC) cannot participate. Ulcerative Colitis is a condition that causes inflammation and sores in the colon and rectum.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
  • Patients who are not part of the specified clinical trial group cannot participate. This means that only certain groups of people, based on specific criteria, are allowed in the study.
  • Both male and female patients can participate, but if a patient does not identify as either, they may not be eligible.
  • Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations can include groups like children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Gyncentrum Sp. z o.o. Katowice Poland
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Futuremeds Sp. z o.o. Wroclaw Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Warsaw Poland

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Spital Judetean De Urgenta Satu Mare Satu Mare Romania
Medrise Sp. z o.o. Lublin Poland
PreventaMed s.r.o. Olomouc Czechia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Centrum Opieki Zdrowotnej Orkan-Med Stec – Michalska Sp. j. Ksawerow Poland
Vitaz Sint-Niklaas Belgium
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Sonomed Sp. z o.o. Szczecin Poland
Centrum Medyczne Oporow Wroclaw Poland
Vasutegeszseguegyi Nonprofit Koezhasznu Kft. Debrecen Hungary
Endoskopia Sp. z o.o. Sopot Poland
Centrul Medical Monza S.R.L. Bucharest Romania
Rivermed Sp. z o.o. Poznan Poland
Clinexpert Kft. Budapest Hungary
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Semmelweis University Budapest Hungary
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Centre Hospitalier Lyon Sud Pierre Benite France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Uniklinikum Salzburg Salzburg Austria
EMC Instytut Medyczny S.A. Poznan Poland
Asociatia Oncohelp Timisoara Romania
H-T. Centrum Medyczne-Endoterapia Tychy Poland
EMC Instytut Medyczny S.A. Wroclaw Poland
Fundeni Clinical Institute Bucharest Romania
Cdno Aeujiz Pougwm Sen z oqrh Warsaw Poland
Igrhsb Bonheiden Belgium
Cgooyvn Iiydfprqjhvaz Tczevon Stk z owcn Piaseczno Poland
Mdgudbhg Sz z olso Bydgoszcz Poland
Wpc Wyhbns Ikt Pbhib Pxinpvta Kpykerp 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
Not recruiting
02.08.2024
Belgium Belgium
Not recruiting
02.08.2024
Czechia Czechia
Not recruiting
02.08.2024
France France
Not recruiting
02.08.2024
Germany Germany
Not recruiting
02.08.2024
Hungary Hungary
Not recruiting
02.08.2024
Italy Italy
Not recruiting
02.08.2024
Poland Poland
Not recruiting
02.08.2024
Romania Romania
Not recruiting
02.08.2024
Spain Spain
Not recruiting
02.08.2024

Trial locations

Investigated drugs:

GS-1427 is a medication being studied for its potential to help people with moderately to severely active ulcerative colitis. The trial aims to see how effective and safe this medication is in improving the symptoms of ulcerative colitis over a 12-week period. Participants in the study will receive this medication to evaluate its ability to provide a clinical response, which means reducing the symptoms and inflammation associated with the condition.

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:
2023-508304-38-00
Protocol code:
GS-US-409-5704
NCT ID:
NCT06290934
Trial Phase:
Therapeutic exploratory (Phase II)

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