Study of JNJ-78934804 (guselkumab and golimumab) versus guselkumab in adults with moderately to severely active Crohn’s disease

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What is this study about?

Crohn’s Disease is a long‑lasting condition that causes inflammation in the digestive tract, leading to abdominal pain, diarrhea, weight loss and fatigue. The study focuses on people whose disease is moderately to severely active, meaning symptoms are frequent and affect daily life. The investigational medicine being tested is called JNJ-78934804, which contains two active substances, guselkumab and golimumab. It is given as a liquid that is injected subcutaneous (under the skin) using a pre‑filled syringe. For comparison, another group receives only guselkumab in the same type of injection.

The purpose of the study is to find out whether JNJ-78934804 can bring participants to a state of clinical remission (no noticeable symptoms) and an endoscopic remission (no visible inflammation when doctors look inside the gut with a camera) by week 48. Participants will receive a series of injections over about a year and will attend regular clinic visits where doctors check health, assess symptoms and may perform simple imaging to look at the gut. Throughout the study, neither the participants nor the treating doctors know which medication is being given, helping to keep the results unbiased.

1 enrollment and baseline assessment

after joining the study, a series of initial examinations are performed to record the current condition of the disease. these may include medical history, physical examination, laboratory tests, and imaging of the intestines. the information collected serves as a reference point for later comparisons.

2 randomization to a treatment group

the participant is assigned, by a computer system, to one of two groups without knowing which group is received. this process ensures that the assignment is unbiased. the two possible groups are the test medication JNJ-78934804 (which contains guselkumab and golimumab) or the comparator medication guselkumab alone.

3 administration of study medication

the first dose of the assigned medication is given by subcutaneous injection (injection under the skin). the exact amount of the drug and the schedule for additional doses are defined by the study protocol and will continue for the duration of the trial, which lasts up to week 48. the test medication is supplied as a solution for injection, while the comparator is provided in a pre‑filled syringe.

4 regular follow‑up visits and safety monitoring

throughout the study, the participant attends scheduled visits to check for any side effects, to have blood drawn for laboratory tests, and to answer questionnaires about symptoms. these visits also provide any additional doses of the medication according to the predetermined schedule.

5 week 48 efficacy evaluation

at the end of week 48, doctors assess two main outcomes: clinical remission (meaning the signs and symptoms of Crohn’s disease have improved to a predefined level) and endoscopic remission (meaning the lining of the intestine looks healed when examined with an endoscope). the results determine whether the test medication performed better than the comparator.

6 study completion

after the week 48 assessment, the participant’s involvement in the trial ends. any further medical care will be managed by the participant’s regular healthcare provider.

Who Can Join the Study?

  • Be at least 18 years old when you give consent to join the study.
  • Have a diagnosis of Crohn’s disease that was confirmed at least 12 weeks ago by both an endoscopic exam (a camera looking inside the intestine) and a tissue test (histopathology report).
  • Have moderately to severely active disease, shown by a Crohn’s Disease Activity Index (CDAI) score of 220 to 450, and also either an average of 4 or more bowel movements each day or an abdominal pain rating of 2 or higher on a simple pain scale.
  • Show a screening Simple Endoscopic Score for Crohn’s Disease (SES‑CD) of 6 or higher (or 4 or higher if the disease is only in the ileum, the last part of the small intestine).
  • Have had an inadequate initial response, loss of response over time, or been unable to tolerate previously approved systemic therapies (medicines that work throughout the whole body) for Crohn’s disease.

Who Cannot Join the Study?

  • Having a diagnosis of any type of colitis that is not Crohn’s disease, such as indeterminate colitis (unclear type), microscopic colitis (inflammation seen only under a microscope), ischemic colitis (damage caused by reduced blood flow), or ulcerative colitis (UC) (a different inflammatory bowel disease).
  • Having a history of short bowel syndrome (where a large part of the intestine is missing or removed), missing more than two of the five main sections of the intestine called the ileocolonic segments, or any other health problem that could make it hard to tell whether the study drug works.
  • Previously showing a weak or no initial response, losing the benefit, or having an allergy, strong reaction (hypersensitivity), 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 medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
DRK Kliniken Berlin Berlin Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Rostock University Medical Center Rostock Germany
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Universitetssykehuset Nord-Norge HF Tromsø Norway
Evangelismos S.A. Athens Greece
University General Hospital Of Ioannina Ioannina Greece
Fakultni Thomayerova nemocnice Prague Czechia
University Hospital Ostrava Ostrava Czechia
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Cliniq s.r.o. Bratislava Slovakia
Centro Hospitalar de Setubal E.P.E. Setubal Portugal
KM Management spol. s r.o. Nitra Slovakia
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Iscare a.s. Prague Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Olavs Hospital HF Trondheim Norway
Sykehuset Innlandet HF Brumunddal Norway
Algemeen Ziekenhuis Delta Roeselare Belgium
Krankenhaus Waldfriede e.V. Berlin Germany
Hospital Universitario Infanta Leonor Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
Area Sanitaria De Ferrol Ferrol Spain
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Eugastro GmbH Leipzig Germany
Gastro LM s.r.o. Presov Slovakia
Azorg Aalst Belgium
Medizinisches Versorgungszentrum Dachau Dachau Germany
GASTRO-Studien Berlin Germany
Sykehuset Ostfold HF Moss Norway
Oblastni nemocnice Kladno a.s. nemocnice Stredoceskeho kraje Kladno Czechia
Gastroenterologie Berlin Berlin Germany
Cmdtpwhqi Ugwibsxgvzezmi Sbtwhobmc Woluwe-Saint-Lambert Belgium
Uedwzftm Viispnli Necsevhpo Sgo Ruqqbhcjsb Fdtmbqcp Nhzjqqwqo Ruzomberok Slovakia
Lvymc Gwptrwp Hjamhtbt Ok Agxtcm Athens Greece
Gqhamkhkchgzgydxk Omxfqnjfinx Kassel Germany
Acvsqrdc Uknfwwyeyn Hinfgcuq Lorenskog Norway
Ezdwbpb Uwksvruswzco Mgvjmlk Crxhwha Rlklqwith (khkjqni Mqs Rotterdam The Netherlands
Skq Edpbkjmpu Hsqmzmpl Tygpdxv Tilburg The Netherlands
Asspgxcep Uyh Amsterdam The Netherlands
Gzljvr Uxrqkmucfn Fxfyhupki Frankfurt Germany
Kfjmnufl dub Uzrzkhstdhpi Mgqocjbs Axh Munich Germany
Htrqp Mnhml Oc Rrngicx Hg Aalesund Norway
Uiaqfktqth Ok Ayzinmz Edegem Belgium
Ipaxkzfow Fwr Cigpmdny Ard Edchlddvuwby Mohleyvl Prague Czechia
Mwyslwwtaborcmfvkxyjgiwxox Hpcvxowiofwcpkgk Halle (Saale) Germany
Uztycdqxowzrvrtxhxgtf Avlsyodl Augsburg Germany
Czabsivi Hcbayehbylfo Usgvxehciuojc Dp Vlcm Vigo Spain
Swgmekgznckjmycvbvp Byh Uy (jxqawemnxwkrskscqlni Halle (Saale) Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
03.08.2026
Czechia Czechia
Not yet recruiting
03.08.2026
Germany Germany
Not yet recruiting
03.08.2026
Greece Greece
Not yet recruiting
03.08.2026
Norway Norway
Not yet recruiting
03.08.2026
Portugal Portugal
Not yet recruiting
03.08.2026
Slovakia Slovakia
Not yet recruiting
03.08.2026
Spain Spain
Not yet recruiting
03.08.2026
The Netherlands The Netherlands
Not yet recruiting
03.08.2026

Trial locations

Investigated Drugs:

JNJ-78934804 is the experimental treatment being tested in this study. It is a combination of two medicines, guselkumab and golimumab, that are given as a liquid injection under the skin. The purpose of this medication in the trial is to see if the combined effect of these two drugs can improve symptoms and reduce inflammation in people with moderate to severe Crohn’s disease compared with the standard therapy.

Guselkumab is the active‑controlled comparator used in the trial. It is a single‑ingredient medicine that is also given as a liquid injection under the skin. In the study, it serves as the reference treatment to determine whether the new combination drug (JNJ‑78934804) works better, the same, or worse than an existing therapy for Crohn’s disease.

Crohn’s disease – Crohn’s disease is a chronic inflammatory condition that primarily affects the digestive tract, especially the small intestine and colon. In moderately to severely active disease, inflammation causes persistent abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can lead to ulcers, narrowing of the intestine, and formation of fistulas. Over time, the affected bowel can become scarred, leading to strictures that may block the passage of food. Symptoms may flare up and then improve, creating a pattern of relapsing activity.

Trial ID:
2026-525922-39-00
Protocol code:
78934804CRD3001
Trial Phase:
Therapeutic confirmatory (Phase III)

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