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Efficacy and Safety of JNJ-78934804 (guselkumab and golimumab) in Adults with Moderately to Severely Active Ulcerative Colitis

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on ulcerative colitis, a condition where the lining of the large intestine becomes inflamed, causing diarrhea, abdominal pain, and bleeding. The trial includes people whose disease is moderate to severe, meaning symptoms are frequent and affect daily life. The investigational medicine is identified as JNJ-78934804, which contains two active substances, guselkumab and golimumab, and is given as a subcutaneous injection (a shot under the skin). For comparison, participants may receive the approved drug guselkumab alone, also given as a subcutaneous injection.

The main goal of the study is to see whether the new combination works better and is safe compared with the single drug. Participants will receive their assigned injection at regular visits over about one year, and they will come to the clinic for check‑ups, blood tests, and questionnaires about symptoms. The study is double‑blind, meaning neither the participants nor the doctors know which treatment is being given, to keep the results unbiased.

The key result the researchers are looking for is clinical remission at week 48, which means the person's symptoms have cleared enough that they no longer need daily medication for the disease. Throughout the trial, safety will be monitored by checking for any side effects or changes in health.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After agreeing to join the study, you will sign a consent form that explains the purpose of the trial and what will be required of you.

  2. Step 2

    Baseline assessments

    Initial medical examinations, blood tests, and questionnaires will be performed to record the current status of your ulcerative colitis and overall health.

    These results create a reference point for later comparisons.

  3. Step 3

    Randomization to study medication

    You will be randomly assigned to receive either the investigational drug jnj-78934804 or the comparator drug guselkumab.

    The assignment is done by a computer system and you will not know which medication you receive.

  4. Step 4

    Start of study medication

    The assigned medication is given by subcutaneous injection (injection under the skin).

    The specific dose is listed as 0 u unit(s) in the study documentation, which indicates that the exact amount is defined by the study protocol and not disclosed here.

    The frequency and duration of the injections are determined by the study schedule, but those details are not provided in the available information.

  5. Step 5

    Regular follow‑up visits

    You will attend scheduled clinic visits at several time points (for example, weeks 4, 12, 24, and 48) to allow investigators to check your health, collect blood samples, and record any side effects.

    During each visit, the study staff will ask about symptoms of ulcerative colitis and any changes since the last appointment.

  6. Step 6

    Primary efficacy assessment at week 48

    At week 48, a formal evaluation will be performed to determine whether you have achieved clinical remission, which is the main goal of the trial.

    This assessment includes a combination of symptom questionnaires, endoscopic examination, and laboratory tests.

  7. Step 7

    End of study participation

    After the week‑48 assessment, the study treatment period ends.

    You will receive information about the results of the trial and any recommended follow‑up care.

Who can join the trial?

5 criteria

  • Be at least 18 years old when you sign the consent form.
  • Have a diagnosis of Ulcerative Colitis that was made at least 12 weeks before screening, confirmed by both an endoscopy (a camera exam of the colon) and a histopathology report (microscopic examination of tissue).
  • Your disease must be moderately to severely active, which means a score of 5 to 9 on the modified Mayo score (a tool that rates symptoms and colon appearance) at the start of the study.
  • The endoscopy subscore (the part of the Mayo score that looks at the colon view) must be 2 or higher.
  • You must have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies (medications that affect the whole body).

Who cannot join the trial?

5 criteria

  • Having a diagnosis of indeterminate colitis (unclear type of colon inflammation), microscopic colitis (inflammation seen only under a microscope), ischemic colitis (colon inflammation caused by reduced blood flow), Crohn’s colitis or any signs that suggest Crohn’s disease (CD).
  • Having isolated proctitis, which means ulcerative colitis limited only to the rectum or to less than 20 cm from the opening of the anus, as identified by a video endoscopy review.
  • Having a history of, or currently having, a long‑lasting or repeatedly occurring infectious disease (any disease caused by bacteria, viruses, or other germs).
  • Previously showing a poor initial reaction, losing the benefit, or having an allergy, extra‑sensitive reaction, or inability to tolerate the medicines guselkumab or golimumab.
  • Being pregnant, breastfeeding, planning to become pregnant, or planning to father a child while in the study or within six months after the last dose of the study drug.
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Investigated drugs

  • JNJ-78934804

    is an investigational injection that combines two medicines, guselkumab and golimumab, which belong to a class of drugs that target the immune system. In this study, participants receive the injection under the skin to see if the combined effect can improve symptoms of moderately to severely active ulcerative colitis compared with the single‑drug treatment.

  • Guselkumab

    is an approved medication that is also given as an injection under the skin. It works by blocking a specific protein that contributes to inflammation. In the trial, it is used as the active control (comparator) so researchers can compare its effectiveness and safety with the new combination therapy, JNJ-78934804.

What is already known about the treatment

  • JNJ-78934804

    This investigational drug is given by injection under the skin as a liquid solution. It combines two antibody medicines, guselkumab and golimumab, and is currently being studied in phase 3 trials for moderately to severely active ulcerative colitis. Guselkumab works by blocking a protein called interleukin‑23, while golimumab blocks the inflammation‑promoting protein tumor‑necrosis factor‑alpha; together they help calm the immune system. The product belongs to the class of biologic immunomodulators that target specific immune signals.

  • Guselkumab

    Guselkumab is administered as a subcutaneous injection using a pre‑filled syringe containing a clear solution. It is an approved biologic medication for conditions such as plaque psoriasis and is now being tested for ulcerative colitis in clinical studies. The drug works by attaching to interleukin‑23 and preventing it from activating immune cells that cause inflammation. It is classified as an anti‑IL‑23 biologic agent that modulates the immune response.

Investigated diseases

Moderately to Severely Active Ulcerative Colitis - Ulcerative colitis is a long‑lasting condition that causes inflammation and sores in the lining of the large intestine. In the moderately to severely active stage, the inflammation spreads over a large part of the colon and produces frequent diarrhea, blood in the stool, and abdominal pain. The disease tends to flare up, with periods of worsening symptoms followed by times of less activity. Over time the inflamed area can become thicker and scarred, which may lead to reduced bowel function. The condition can affect daily life because symptoms often appear suddenly and can be intense.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525923-26-00Protocol code78934804UCO3001Estimated enrolment644 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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