A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Feb 15, 2022
Trial Information
Current as of May 27, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment approach for people with moderately to severely active ulcerative colitis (UC), a condition that causes inflammation and ulcers in the digestive tract. The study is comparing a combination of two medications, guselkumab and golimumab, to see how well they work and how safe they are for patients who haven't had enough improvement from other treatments. Participants in this study must have been diagnosed with UC for at least three months and have previously tried at least one other treatment without success.
To be eligible for the trial, participants should be between the ages of 18 and 75 and need to have a confirmed diagnosis of UC. They should also have shown that previous treatments did not work well for them. However, individuals with certain other types of colitis or severe infections won't be able to join. Those who participate can expect regular check-ups and monitoring throughout the study to track their health and response to the treatment. Overall, this trial aims to find better ways to help manage ulcerative colitis for patients who are struggling with their symptoms.
Gender
ALL
Eligibility criteria
- 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)
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
New Haven, Connecticut, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Baltimore, Maryland, United States
Haifa, , Israel
Seattle, Washington, United States
Toronto, Ontario, Canada
Zerifin, , Israel
Thessaloniki, , Greece
Ann Arbor, Michigan, United States
San Francisco, California, United States
Cincinnati, Ohio, United States
Clichy, , France
Miami, Florida, United States
Washington, District Of Columbia, United States
Winnipeg, Manitoba, Canada
Saint Louis, Missouri, United States
Belfast, , United Kingdom
Aurora, Colorado, United States
Haifa, , Israel
Gent, , Belgium
Atlanta, Georgia, United States
Seattle, Washington, United States
New Haven, Connecticut, United States
Rehovot, , Israel
Los Angeles, California, United States
Chevy Chase, Maryland, United States
Hannover, , Germany
Parkville, , Australia
Tacoma, Washington, United States
Kyoto, , Japan
Ulm, , Germany
Oxford, , United Kingdom
Keighley, , United Kingdom
Lexington, Kentucky, United States
Perth, , Australia
Ljubljana, , Slovenia
Changhua, , Taiwan
Leiden, , Netherlands
Zagreb, , Croatia
Louisville, Kentucky, United States
Bonheiden, , Belgium
Odense, , Denmark
Christchurch, , New Zealand
Kurume, , Japan
Aalborg, , Denmark
Freiburg, , Germany
Birmingham, , United Kingdom
Utrecht, , Netherlands
Utrecht, , Netherlands
Trondheim, , Norway
Bruxelles, , Belgium
Bruxelles, , Belgium
Clichy, , France
Cleveland, Ohio, United States
Jerusalem, , Israel
Taichung, , Taiwan
Rotterdam, , Netherlands
Stockholm, , Sweden
Gifu, , Japan
Bruxelles, , Belgium
Osaka, , Japan
Heidelberg, , Germany
Wolverhampton, , United Kingdom
Leuven, , Belgium
New York, New York, United States
Tallinn, , Estonia
Kumamoto, , Japan
Wellington, , New Zealand
London, Ontario, Canada
Würzburg, , Germany
Ulm, , Germany
Aalst, , Belgium
Rotterdam, , Netherlands
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
New Delhi, , India
Dudley, , United Kingdom
Oita, , Japan
Porto Alegre, Rio Grande Do Sul, Brazil
Calgary, Alberta, Canada
Camperdown, , Australia
Athens, , Greece
Tel Hashomer, , Israel
Tallinn, , Estonia
New York, New York, United States
New Delhi, , India
Hirosaki, , Japan
Cambridge, , United Kingdom
Lille, , France
Milwaukee, Wisconsin, United States
Tainan, , Taiwan
Chestnut Hill, Massachusetts, United States
Roma, , Italy
Kobe, , Japan
Tsu, , Japan
Seoul, , Korea, Republic Of
Wien, , Austria
Tokyo, , Japan
Mannheim, , Germany
Warszawa, , Poland
Naples, Florida, United States
Chengdu, , China
Warszawa, , Poland
Aarhus, , Denmark
Bern, , Switzerland
Wels, , Austria
Brugge, , Belgium
Mannheim, , Germany
Jena, , Germany
Olsztyn, , Poland
Jerusalem, , Israel
Liege, , Belgium
Tartu, , Estonia
Amman, , Jordan
Indianapolis, Indiana, United States
Brno, , Czechia
Marietta, Georgia, United States
Budapest, , Hungary
Dordrecht, , Netherlands
Dunedin, , New Zealand
Lisboa, , Portugal
Lille, , France
Amsterdam, , Netherlands
Gent, , Belgium
Tokyo, , Japan
Maastricht, , Netherlands
Daegu, , Korea, Republic Of
Wien, , Austria
Graz, , Austria
Germantown, Tennessee, United States
Wels, , Austria
Wien, , Austria
Sopot, , Poland
Warszawa, , Poland
Porto Alegre, , Brazil
Zuerich, , Switzerland
Jena, , Germany
Seoul, , Korea, Republic Of
London, , United Kingdom
Split, , Croatia
Amsterdam, , Netherlands
Minden, , Germany
Oslo, , Norway
Saint Cloud, Florida, United States
Liege, , Belgium
Coronado, California, United States
Herlev, , Denmark
Southlake, Texas, United States
Gyeonggi Do, , Korea, Republic Of
Budapest, , Hungary
Grenoble, , France
Marietta, Georgia, United States
Birmingham, , United Kingdom
Belgrade, , Serbia
Seoul, , Korea, Republic Of
Tel Aviv, , Israel
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Mentor, Ohio, United States
Tyler, Texas, United States
Dallas, Texas, United States
Belgrade, , Serbia
Montpellier, , France
Mersin, , Turkey
Stoke On Trent, , United Kingdom
Seoul, , Korea, Republic Of
Munich, , Germany
Budapest, , Hungary
London, , United Kingdom
Rosario, , Argentina
Tzrifin, , Israel
Brussel, , Belgium
Stockholm, , Sweden
Würzburg, , Germany
New Delhi, , India
Monza, , Italy
Murdoch, , Australia
Concord, , Australia
Chengdu, , China
Petah Tikva, , Israel
Bunkyo Ku, , Japan
Daegu, , Korea, Republic Of
Colombes Cedex, , France
Porto Alegre, , Brazil
Saint Brieuc, , France
Pretoria, , South Africa
St. Gallen, , Switzerland
Nishinomiya, , Japan
Nagoya, , Japan
Lueneburg, , Germany
Busan, , Korea, Republic Of
San Giovanni Rotondo, , Italy
Irbid, , Jordan
Morioka, , Japan
Kashihara, , Japan
Amman, , Jordan
Belgrade, , Serbia
Berlin, , Germany
Busan, , Korea, Republic Of
Colorado Springs, Colorado, United States
Brno, , Czechia
Saint Etienne, , France
Torino, , Italy
Daejeon, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Darlinghurst, , Australia
Szczecin, , Poland
Loures, , Portugal
Halifax, Nova Scotia, Canada
Solna, , Sweden
Izmir, , Turkey
Hamden, Connecticut, United States
Santander, , Spain
Valencia, , Spain
Wakayama, , Japan
Osaka, , Japan
Box Hill, , Australia
Lower Hutt, , New Zealand
Belfast, , United Kingdom
Las Vegas, Nevada, United States
Madrid, , Spain
Wrocław, , Poland
Lørenskog, , Norway
Leipzig, , Germany
Seoul, , Korea, Republic Of
Kagoshima, , Japan
Boston, Massachusetts, United States
Barcelona, , Spain
New Albany, Indiana, United States
Erlangen, , Germany
Budapest, , Hungary
Gyongyos, , Hungary
Mitaka, , Japan
Saint Etienne, , France
Ogaki, , Japan
Charlotte, North Carolina, United States
New Delhi, , India
Taichung, , Taiwan
Yokohama, , Japan
Bangalore, , India
Kamakura, , Japan
Minato Ku, , Japan
Sakura, , Japan
Sapporo, , Japan
Hachioji, , Japan
Osaka, , Japan
Lucknow, , India
Bunkyo Ku, , Japan
Jerichow, , Germany
Szczecin, , Poland
Kyoto, , Japan
Tokyo, , Japan
Nagoya, , Japan
Santo André, , Brazil
Homestead, Florida, United States
Arnhem, , Netherlands
Porto Alegre, , Brazil
Lebanon, New Hampshire, United States
Gyeonggi Do, , Korea, Republic Of
Antwerpen, , Belgium
Liège, , Belgium
Praha 9, , Czechia
Pierre Bénite, , France
Palermo, , Italy
Banska Bystrica, , Slovakia
Presov, , Slovakia
Vranov Nad Toplou, , Slovakia
London, , United Kingdom
Hamamatsu, , Japan
Sliven, , Bulgaria
Copenhagen, , Denmark
Krakow, , Poland
Chapel Hill, North Carolina, United States
Trabzon, , Turkey
Rzeszow, , Poland
Chikushino, , Japan
Bjelovar, , Croatia
Sapporo, , Japan
Vrsac, , Serbia
Liverpool, , Australia
Vancouver, British Columbia, Canada
Kyoto, , Japan
Lancaster, California, United States
Oslo, , Norway
Bern, , Switzerland
Rio De Janeiro, , Brazil
South Brisbane, , Australia
Hwaseong Si, , Korea, Republic Of
Toyota, , Japan
Vigo, , Spain
São Paulo, , Brazil
Pamplona, , Spain
Wroclaw, , Poland
Wien, , Austria
Krakow, , Poland
Seoul, , Korea, Republic Of
Montreal, Quebec, Canada
Crestview Hills, Kentucky, United States
Ypsilanti, Michigan, United States
Bellevue, Washington, United States
Clayton, , Australia
Brno, , Czechia
Szombathely, , Hungary
Messina, , Italy
Zamosc, , Poland
Coconut Creek, Florida, United States
Orlando, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
Roswell, Georgia, United States
Kinston, North Carolina, United States
Springboro, Ohio, United States
Scranton, Pennsylvania, United States
San Antonio, Texas, United States
Footscray, , Australia
North Terrace, , Australia
Prahran, , Australia
Salzburg, , Austria
Botucatu, , Brazil
Caxias Do Sul, , Brazil
Curitiba, , Brazil
Goiania, , Brazil
Santo Andre, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Dartmouth, , Canada
Hangzhou, , China
Zagreb, , Croatia
Créteil, , France
Nice Cedex 03, , France
Berlin Karlshorst, , Germany
Berlin, , Germany
Düsseldorf, , Germany
Frankfurt/Main, , Germany
Halle, , Germany
Saarbrücken, , Germany
Athens, , Greece
Szeged, , Hungary
Jaipur, , India
Surat, , India
Catania, , Italy
Padova, , Italy
Roma, , Italy
Isehara, , Japan
Kagoshima, , Japan
Kashiwa, , Japan
Osaka Shi, , Japan
Sapporo Chuo Ku, , Japan
Sapporo, , Japan
Irbid, , Jordan
Seoul, , Korea, Republic Of
Kaunas, , Lithuania
Alesund, , Norway
Ksawerów, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Poznan, , Poland
Toruń, , Poland
Wloclawek, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Portimao, , Portugal
Santa Maria Da Feira, , Portugal
Belgrade, , Serbia
Zrenjanin, , Serbia
Torrejón De Ardoz, , Spain
Bern, , Switzerland
D:14/4 Nisantasi, , Turkey
High Wycombe, , United Kingdom
London, , United Kingdom
La Roche Sur Yon, , France
Kaunas, , Lithuania
Seoul, , Korea, Republic Of
Lublin, , Poland
Monserrato, , Italy
São Paulo, , Brazil
Wuhan, , China
Chestnut Hill, Massachusetts, United States
Wonju, , Korea, Republic Of
Ciudad Autonoma De Buenos Aires, , Argentina
Monterrey, , Mexico
Tel Aviv Yafo, , Israel
Berlin, , Germany
Dresden, , Germany
Tübingen, , Germany
Pontevedra, , Spain
Sabadell, , Spain
St. Gallen, , Switzerland
Tilburg, , Netherlands
Tsukuba City, , Japan
Nürtingen, , Germany
Busan, , Korea, Republic Of
Afula, , Israel
Chiba, , Japan
Jinhua, , China
Asahikawa, , Japan
Macon, Georgia, United States
Cordoba, , Argentina
Mar Del Plata, , Argentina
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Pessac, , France
Vandoeuvre Les Nancy, , France
Fukuoka Ken, , Japan
Hirosaki, , Japan
Kanagawa, , Japan
Bratislava, , Slovakia
Taoyuan, , Taiwan
Ankara, , Turkey
Milano, , Italy
Kofu Shi, , Japan
Jönköping, , Sweden
Amiens Cedex 1, , France
Toyama, , Japan
Taichung, , Taiwan
Maebashi, , Japan
Houston, Texas, United States
Charlotte, North Carolina, United States
Santiago, , Chile
Belgrade, , Serbia
Porto Alegre, , Brazil
Banska Bystrica, , Slovakia
Porto Alegre, , Brazil
London, , United Kingdom
Uniontown, Pennsylvania, United States
Warszawa, , Poland
Nîmes, , France
Tokyo, , Japan
La Jolla, California, United States
San Diego, California, United States
Middletown, New York, United States
Santos, , Brazil
Saint Jerome, Quebec, Canada
Victoria, , Canada
Santiago, , Chile
Nykøbing Falster, , Denmark
Berlin, , Germany
Pforzheim, , Germany
Budapest, , Hungary
Hamilton, , New Zealand
Nowy Targ, , Poland
Warszawa, , Poland
Vila Nova De Gaia, , Portugal
Kaoshiung, , Taiwan
Taipei, , Taiwan
Glasgow, Lanarkshire, United Kingdom
Arcadia, California, United States
Las Vegas, Nevada, United States
Cleveland, Ohio, United States
Rock Hill, South Carolina, United States
Nashville, Tennessee, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Linz, , Austria
Sint Niklaas, , Belgium
São Paulo, , Brazil
Bridgewater, , Canada
Calgary, , Canada
Concepcion, , Chile
Fulda, , Germany
Heidelberg, , Germany
Mainz, , Germany
Athens, , Greece
Secunderabad, , India
Cuernavaca, , Mexico
Guadalajara, , Mexico
Gjøvik, , Norway
Lodz, , Poland
Celje, , Slovenia
Basel, , Switzerland
Bülach, , Switzerland
Lakewood Ranch, Florida, United States
Idaho Falls, Idaho, United States
Columbia, Missouri, United States
Utica, New York, United States
Johnson City, Tennessee, United States
Spring, Texas, United States
Richmond, Virginia, United States
Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Maroochydore, , Australia
Salvador, , Brazil
Sao Paulo, , Brazil
Haskovo, , Bulgaria
Pleven, , Bulgaria
Sofia Grad, , Bulgaria
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Vratsa, , Bulgaria
Santiago, , Chile
Marseille, , France
Toulouse Cedex 09, , France
Halle, , Germany
Munster, , Germany
Münster, , Germany
Wipperfürth, , Germany
Piraievs, , Greece
Jaipur, , India
Saltillo, , Mexico
Amsterdam, , Netherlands
Maribor, , Slovenia
Genève, , Switzerland
Hexham, , United Kingdom
Frankfurt, , Germany
Thiruvananthapuram, , India
Madison, Wisconsin, United States
Saguenay, , Canada
Münster, , Germany
Bhubaneswar, , India
Bari, , Italy
Guadalajara, , Mexico
Tromso, , Norway
Poznan, , Poland
Benoni, , South Africa
Soweto, , South Africa
Nottingham, , United Kingdom
Istambul, , Turkey
Sao Paulo, , Brazil
Porto Alegre, , Brazil
Negrar Di Valpolicella, , Italy
Edmonton, , Canada
Kissimmee, Florida, United States
Rosario, , Argentina
Mont Royal, Quebec, Canada
Edmonton, , Canada
Silkeborg, , Denmark
Halle (Saale), , Germany
Wonju, Gangwon Do, , Korea, Republic Of
Mexico, , Mexico
Yucatan, , Mexico
Bydgoszcz, , Poland
Viseu, , Portugal
Cape Town, , South Africa
Johannesburg, , South Africa
Montreal, Quebec, Canada
Bhubaneswar, , India
Rio De Janeiro, , Brazil
Praha 9, , Czechia
Sumida Ku, , Japan
Cape Town, , South Africa
Rosario, , Argentina
Goiania, , Brazil
Marseille, , France
Saint Etienne, , France
Tomakomai, , Japan
Rozzano, , Italy
Marseille, , France
Vandoeuvre Les Nancy, , France
Munich, , Germany
New Delhi, , India
Torun, , Poland
Bunkyo Ku, , Japan
Caxias Do Sul, , Brazil
Porto Alegre, , Brazil
Neuilly Sur Seine, , France
Sao Paulo, , Brazil
High Wycombe, , United Kingdom
Marseille, , France
Salvador, , Brazil
Krakow, , Poland
Dartmouth, Nova Scotia, Canada
Edmonton, Alberta, Canada
Gjettum, , Norway
Barcelona, , Spain
Seoul, , Korea, Republic Of
Wroclaw, , Poland
Kissimmee, Florida, United States
Victoria, British Columbia, Canada
Berlin, , Germany
Lisboa, , Portugal
Salzburg, , Austria
Edmonton, Alberta, Canada
Petah Tikva, , Israel
Oslo, , Norway
Brasilia, , Brazil
Loures, , Portugal
Brasilia, , Brazil
Nîmes, , France
Pforzheim, , Germany
Sliven, , Bulgaria
Chaoyang, , China
Szeged, , Hungary
São Paulo, , Brazil
Yokohama, , Japan
Sao Paulo, , Brazil
Nanjing, , China
Sao Paulo, , Brazil
Seoul, , Korea, Republic Of
Santiago, , Chile
Tokyo, , Japan
Wakayama, , Japan
Tel Aviv Yafo, , Israel
Wrocław, , Poland
Bunkyo Ku, , Japan
Tsukuba City, , Japan
Salvador, , Brazil
Sumida Ku, , Japan
Tokyo, , Japan
Vila Nova De Gaia, , Portugal
Barcelona, , Spain
Salzburg, , Austria
Chaoyang, , China
Vila Nova De Gaia, , Portugal
São Paulo, , Brazil
Montreal, Quebec, Canada
Nagoya, , Japan
Sao Paulo, , Brazil
Wroclaw, , Poland
Brasilia, , Brazil
Loures, , Portugal
Warszawa, , Poland
Vila Nova De Gaia, , Portugal
Hangzhou, , China
Wroclaw, , Poland
Wroclaw, , Poland
Nowy Targ, , Poland
Olsztyn, , Poland
Poznan, , Poland
Torun, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Toronto, Ontario, Canada
Kyoto, , Japan
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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