Study on the Effectiveness and Safety of Guselkumab and Ustekinumab for Patients with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Guselkumab in individuals with moderately to severely active Crohn’s disease. Crohn’s disease is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study aims to evaluate how effective and safe Guselkumab is for treating this condition. Guselkumab is administered as a solution for injection, and participants may also receive a placebo or another medication called Ustekinumab for comparison.

The trial is designed to be conducted in two phases. In the first phase, the focus is on assessing the clinical efficacy, which means how well the medication works in reducing the symptoms of Crohn’s disease. The second phase will look at both clinical and endoscopic efficacy, which involves using a camera to examine the inside of the digestive tract to see how the medication affects the inflammation. Participants will receive the treatment over a period of time, and their progress will be monitored to gather information on the medication’s safety and effectiveness.

Throughout the study, participants will receive injections of Guselkumab or Ustekinumab, or a placebo, and their health will be closely monitored by healthcare professionals. The study will help determine if Guselkumab can be a beneficial treatment option for people with Crohn’s disease, providing valuable insights into managing this challenging condition. The trial is expected to continue until 2027, allowing researchers to collect comprehensive data on the long-term effects of the treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of Crohn’s disease. This includes reviewing medical history and conducting necessary tests such as radiography, histology, or endoscopy.

2 screening tests

Screening tests are performed to ensure eligibility. These include laboratory tests to check health parameters and a pregnancy test for female participants of childbearing potential.

3 randomization

Participants are randomly assigned to receive either guselkumab, ustekinumab, or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

4 treatment phase 2

During Phase 2, participants receive guselkumab via subcutaneous injection. The dosage is 100 mg/mL, administered according to the study schedule. The primary goal is to evaluate changes in the Crohn’s Disease Activity Index (CDAI) score at Week 12.

5 treatment phase 3

In Phase 3, the treatment continues with guselkumab to assess both clinical and endoscopic efficacy. The primary endpoints include clinical response and remission at Week 12 and Week 48, as well as endoscopic response at these intervals.

6 safety monitoring

Throughout the trial, safety is monitored closely. Regular check-ups and tests are conducted to ensure the well-being of participants and to track any side effects or adverse reactions.

7 end of study

The study concludes with a final assessment to evaluate the overall efficacy and safety of guselkumab in treating moderately to severely active Crohn’s disease. Results are compared to baseline measurements and placebo effects.

Who Can Join the Study?

  • Have Crohn’s disease or fistulizing Crohn’s disease for at least 3 months. This means having inflammation in the digestive tract, confirmed by tests like X-rays, tissue samples, or a camera exam.
  • Have moderate to severe Crohn’s disease. This is determined by specific scores that measure symptoms like stool frequency and abdominal pain, as well as a score from a camera exam of the intestines.
  • Have lab test results that meet the study’s specific requirements.
  • If female and able to have children, must have a negative pregnancy test at the start of the study.
  • Have shown that standard treatments or special medications for Crohn’s disease do not work well or cause bad reactions.

Who Cannot Join the Study?

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain medications that could affect the study results.
  • Patients who have a history of certain mental health conditions that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
NH Hospital a.s. Horovice Czechia
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Warsaw Poland

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Iscare a.s. Prague Czechia
CHU Saint Pierre Brussels Belgium
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Synexus Czech s.r.o. Prague Czechia
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Area Sanitaria De Ferrol Ferrol Spain
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Santa Maria Da Feira Portugal
Eugastro GmbH Leipzig Germany
Endoskopia Sp. z o.o. Sopot Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Melita Medical sp. z o.o. Wroclaw Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Synexus Polska Sp. z o.o. Poznan Poland
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Gastromed Sp. z o.o. Torun Poland
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Wloclawek Poland
Poliklinika Solmed d.o.o. Zagreb Croatia
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Gastro LM s.r.o. Presov Slovakia
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
EMC Instytut Medyczny S.A. Poznan Poland
Chjeyc Hpiajhqldpe Uundnidejvbkb Rmepo Reims France
Ukdtohetgruuxrtoqblrv Aruhhcod Augsburg Germany
Vqtlvxxk &fyec Vpremrp Srv z ogvs Wroclaw Poland
Pkykexe Msnglh Six z Okcz Eni Pcjjptqra Poniatowa Poland
Atwnvwzrg Uzl Amsterdam The Netherlands
Bbztqulg Ujvockkthe Hjejymmo Civkbh Besançon France
Cdaw Db Nwpim Vandoeuvre Les Nancy France
Wjx Wywfgn Ime Puekt Pbkabubu Kltabdf Warsaw Poland
Mgfnenke Ssg z oszg Oświęcim Poland
Srpscnc Ssce Kluczbork Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
11.09.2018
Croatia Croatia
Not recruiting
11.09.2018
Czechia Czechia
Not recruiting
11.09.2018
France France
Not recruiting
11.09.2018
Germany Germany
Not recruiting
11.09.2018
Hungary Hungary
Not recruiting
11.09.2018
Italy Italy
Not recruiting
11.09.2018
Latvia Latvia
Not recruiting
11.09.2018
Poland Poland
Not recruiting
11.09.2018
Portugal Portugal
Not recruiting
11.09.2018
Slovakia Slovakia
Not recruiting
11.09.2018
Spain Spain
Not recruiting
11.09.2018
The Netherlands The Netherlands
Not recruiting
11.09.2018

Trial locations

Investigated drugs:

Guselkumab is a medication being studied for its effectiveness and safety in treating people with moderately to severely active Crohn’s disease. This trial aims to see how well it works in reducing the symptoms of Crohn’s disease and to ensure it is safe for patients to use.

Crohn’s Disease – Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can vary greatly in severity and symptoms from person to person.

Trial ID:
2023-504736-18-00
Protocol code:
CNTO1959CRD3001
NCT ID:
NCT03466411
Trial Phase:
Therapeutic use (Phase IV)

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