A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Phase 2 – studying effectiveness and dosage
Conditions:
Colitis, Ulcerative
Sponsor: Janssen Research & Development, LLC
trial.available_in:
БГ
Overview
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
Who can participate
Inclusion Criteria:
* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
* Moderately to severely active UC as assessed by the modified Mayo score
* Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
* If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion Criteria:
* Has severe extensive colitis as defined in the protocol
* Extent of inflammatory disease limited to the rectum
* Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
* Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Locations
32
Argentina (1)
CIPREC
Buenos Aires
Australia (1)
Box Hill Hospital
Box Hill
Belgium (1)
Imelda Ziekenhuis
Bonheiden
Brazil (1)
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu
Bulgaria (1)
Medical Centre Hipocrat
Haskovo
Canada (1)
Foothills Hospital
Calgary , Alberta
Chile (1)
Hospital Clinico Regional Dr. Guillermo Grant Benavente
Concepción
China (1)
China Japan Friendship Hospital
Chaoyang
Croatia (1)
Opca bolnica Bjelovar
Bjelovar
Czech Republic (1)
Vojenska nemocnice Brno
Brno
Denmark (1)
Aalborg Hospital
Aalborg
Estonia (1)
East Tallinn Central Hospital
Tallinn
France (1)
CHU Amiens - Hopital Sud
Amiens
Greece (1)
Sotiria General State Hospital of Chest Diseases
Athens
Hungary (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
India (1)
M S Ramaiah Medical College and Hospital
Bangalore
Israel (1)
Haemek Medical Center - Afula
Afula
Italy (1)
Università degli Studi di Bari
Bari
Japan (1)
Asahikawa Medical University Hospital
Asahikawa
Jordan (1)
Istishari Hospital
Amman
Netherlands (1)
Academisch Medisch Centrum Universiteit van Amsterdam