Study on a new combination therapy for active ulcerative colitis

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    What is this study about?

    This study aims to assess the effectiveness and safety of new combination therapy with JNJ-78934804 (Guselkumab/Golimumab) in comparison to guselkumab and golimumab administred alone for individuals with moderately to severely active ulcerative colitis. Participants who have shown inadequate response, loss of response, or intolerance to approved advanced therapies will be included. The trial includes various treatment groups: placebo, Guselkumab, Golimumab, and different doses of JNJ-78934804. All participants meeting inadequate response criteria will be escalated to an active treatment. The study will last for 48 weeks and the progress will be tracked over this period. The primary focus is to evaluate the efficacy and safety of the different doses of new therapy in managing ulcerative colitis over the course of the study.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Wels , Austria

      Wien , Austria

      Bonheiden , Belgium

      Brugge , Belgium

      Bruxelles , Belgium

      Gent , Belgium

      Gent , Belgium

      Leuven , Belgium

      Liege , Belgium

      Liu00e8ge , Belgium

      Sint-Niklaas , Belgium

      Haskovo , Bulgaria

      Sliven , Bulgaria

      Sofia-Grad , Bulgaria

      Sofia , Bulgaria

      Veliko Tarnovo , Bulgaria

      Vratsa , Bulgaria

      Brno , Czechia

      Praha 9 , Czechia

      Aalborg , Denmark

      Aarhus , Denmark

      Copenhagen , Denmark

      Herlev , Denmark

      Odense , Denmark

      AMIENS cedex 1 , France

      Colombes Cedex , France

      Cru00e9teil , France

      Grenoble , France

      La Roche sur Yon , France

      Lille , France

      Marseille , France

      Montpellier , France

      Neuilly-sur-Seine , France

      Nice cedex 03 , France

      Nu00eemes , France

      Pessac , France

      Pierre Bu00e9nite , France

      Saint Etienne , France

      Toulouse cedex 09 , France

      Vandoeuvre-les-Nancy , France

      Berlin-Karlshorst , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Dresden , Germany

      Erlangen , Germany

      Frankfurt/Main , Germany

      Fulda , Germany

      Halle (Saale) , Germany

      Halle , Germany

      Hannover , Germany

      Heidelberg , Germany

      Heidelberg , Germany

      Jena , Germany

      Jerichow , Germany

      Leipzig , Germany

      Mannheim , Germany

      Minden , Germany

      Munich , Germany

      Munster , Germany

      Mu00fcnster , Germany

      Pforzheim , Germany

      Saarbru00fccken , Germany

      Tu00fcbingen , Germany

      Wipperfu00fcrth , Germany

      Wu00fcrzburg , Germany

      Athens , Greece

      Athens , Greece

      Piraievs , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Gyongyos , Hungary

      Szeged , Hungary

      Szombathely , Hungary

      Catania , Italy

      Messina , Italy

      Milano , Italy

      Monserrato , Italy

      Monza , Italy

      Negrar Di Valpolicella , Italy

      Palermo , Italy

      Roma , Italy

      Roma , Italy

      San Giovanni Rotondo , Italy

      Amsterdam , Netherlands

      Maastricht , Netherlands

      Rotterdam , Netherlands

      Utrecht , Netherlands

      Alesund , Norway

      Gjettum , Norway

      Gju00f8vik , Norway

      Lu00f8renskog , Norway

      Oslo , Norway

      Tromso , Norway

      Bydgoszcz , Poland

      Krakow , Poland

      Krakow , Poland

      Lodz , Poland

      Lublin , Poland

      Lublin , Poland

      Olsztyn , Poland

      Poznan , Poland

      Poznan , Poland

      Rzeszow , Poland

      Sopot , Poland

      Szczecin , Poland

      Szczecin , Poland

      Torun , Poland

      Warszawa , Poland

      Warszawa , Poland

      Warszawa , Poland

      Warszawa , Poland

      Warszawa , Poland

      Wloclawek , Poland

      Wroclaw , Poland

      Wroclaw , Poland

      Wrocu0142aw , Poland

      Zamosc , Poland

      Lisboa , Portugal

      Loures , Portugal

      Portimao , Portugal

      Santa Maria da Feira , Portugal

      Vila Nova de Gaia , Portugal

      Banska Bystrica , Slovakia

      Bratislava , Slovakia

      Presov , Slovakia

      Vranov nad Toplou , Slovakia

      Celje , Slovenia

      Ljubljana , Slovenia

      Barcelona , Spain

      Madrid , Spain

      Pamplona , Spain

      Pontevedra , Spain

      Sabadell , Spain

      Santander , Spain

      Torreju00f3n de Ardoz , Spain

      Vigo , Spain

      Solna , Sweden

      Stockholm , Sweden

      Glasgow , United Kingdom

      High Wycombe , United Kingdom

      London , United Kingdom

      London , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Based on the information provided about this clinical trial, here are the key steps a patient would likely need to take:

      1. Screening: Patients would first be screened to ensure they meet the eligibility criteria, which includes:
        • Confirmed diagnosis of ulcerative colitis for at least 3 months
        • Moderately to severely active disease
        • Previous inadequate response, loss of response, or intolerance to at least one biologic therapy
        • Meets contraception requirements if female
      2. Randomization: Eligible patients would be randomly assigned to one of 6 treatment groups:
        • Placebo
        • Guselkumab
        • Golimumab
        • JNJ-78934804 (high dose)
        • JNJ-78934804 (mid dose)
        • JNJ-78934804 (low dose)
      3. Treatment Period: Patients would receive their assigned study drug (or placebo) via subcutaneous injection according to the defined dosing regimen for their group. The primary treatment period appears to last through week 48.
      4. Assessments: Patients would undergo assessments at various timepoints to evaluate efficacy, safety, pharmacokinetics, and immunogenicity. Key assessments include clinical remission at weeks 24 and 48.
      5. Long-Term Extension: Patients who are eligible and willing may continue their assigned treatment beyond week 44 by entering a long-term extension period.

      The total duration of participation for an individual patient could last up to 2030 based on the estimated study completion date. However, the primary analysis period seems to be through week 48 (about 1 year).


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria in the clinical trial information, to join this study you need to have:

      • A confirmed diagnosis of moderately to severely active ulcerative colitis (UC) for at least 3 months prior to baseline

      The study excludes patients with:

      • Current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn’s disease (CD)
      • Severe extensive colitis as defined in the protocol
      • Extent of inflammatory disease limited to the rectum

      So in summary, the key disease you must have is moderately to severely active ulcerative colitis, and you cannot have the other colitis or inflammatory bowel diseases listed in the exclusion criteria.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join this study, you must meet the following inclusion criteria:

      Confirmed Diagnosis of Ulcerative Colitis (UC) for at Least 3 Months Prior to Baseline

      • Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, affecting the innermost lining of the colon and rectum

      Moderately to Severely Active UC as Assessed by the Modified Mayo Score

      • The Modified Mayo Score is a tool used to assess ulcerative colitis disease activity. It takes into account stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment. A higher score indicates more severe disease activity.

      Demonstrated Inadequate Response, Loss of Response, or Intolerance to at Least One Biologic or Novel Oral with Biologic-like Activity

      • Biologics are medications made from living organisms, designed to target specific parts of the immune system that cause inflammation
      • Novel oral medications with biologic-like activity work similarly to biologics but are taken orally
      • Inadequate response means the medication did not work well enough
      • Loss of response means the medication stopped working over time
      • Intolerance means you experienced side effects from the medication that were unacceptable

      If Female and of Childbearing Potential, Must Meet the Contraception and Reproduction Requirements

      • Women who could become pregnant must agree to use contraception during the study

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you cannot take part in the study if:

      Severity and Extent of Ulcerative Colitis

      • You have severe extensive colitis (a very serious and widespread form of ulcerative colitis affecting most of the colon)
      • The inflammatory disease is limited only to the rectum (the last part of the large intestine before the anus)

      Other Forms of Inflammatory Bowel Disease

      • You have a current diagnosis of:
        • Indeterminate colitis (inflammatory bowel disease that has features of both ulcerative colitis and Crohn’s disease)
        • Microscopic colitis (inflammation in the colon that can only be seen under a microscope)
        • Ischemic colitis (inflammation caused by not enough blood flow to the colon)
        • Crohn’s disease (an inflammatory bowel disease that can affect any segment of the gastrointestinal tract from the mouth to the anus)

      Infections

      • You have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to:
        • Sinopulmonary infections (infections of the sinuses and lungs)
        • Bronchiectasis (damage and widening of the large airways in the lungs)
        • Recurrent renal/urinary tract infections like pyelonephritis (kidney infection) or cystitis (bladder infection)
        • An open, draining, or infected skin wound or ulcer

      Cancer

      • You currently have a malignancy (cancer) or a history of malignancy within 5 years before screening, except for:
        • Non-melanoma skin cancer that has been treated with no evidence of recurrence within 12 months
        • Cervical carcinoma in situ (pre-cancer) that has been treated with no evidence of recurrence within 12 months

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in this study are:

      • Guselkumab: A biologic medication that inhibits interleukin-23 (IL-23). It is being evaluated for its efficacy in treating moderately to severely active ulcerative colitis.
      • Golimumab: A tumor necrosis factor (TNF) inhibitor biologic medication. It is also being studied for its effectiveness in treating moderately to severely active ulcerative colitis.
      • JNJ-78934804: An investigational biologic medication being developed by Janssen. The active substance is not specified. Different dose regimens of JNJ-78934804 are being compared against guselkumab, golimumab, and placebo to determine its efficacy and safety in treating moderately to severely active ulcerative colitis.
      • Placebo: An inactive substance used as a control in the study to compare against the active medications. Some participants will receive a placebo instead of an active drug.

      The study aims to evaluate the efficacy and safety of combination therapy with guselkumab and golimumab compared to each drug alone, different dose regimens of the investigational drug JNJ-78934804, and placebo in participants with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or intolerance to previous therapies.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Based on the information provided in the clinical trial record, the active substances being studied are:

      • Guselkumab: Yes, guselkumab is a known medication. It is an approved treatment for plaque psoriasis and psoriatic arthritis.
      • Golimumab: Yes, golimumab is an established medication. It is currently approved for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
      • JNJ-78934804: No, JNJ-78934804 appears to be an investigational drug that is not yet well known or approved. The trial is studying it as a potential new treatment for ulcerative colitis.

      In summary, guselkumab and golimumab are known, approved medications, while JNJ-78934804 is an experimental substance still being researched for efficacy and safety in treating ulcerative colitis.


      Study ID

      CT-EU-00057209

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      II