Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Launched by ABBVIE · Mar 13, 2023
Trial Information
Current as of May 16, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Upadacitinib (also known as RINVOQ) to see how safe and effective it is for children and teenagers with moderately to severely active ulcerative colitis (UC). UC is a condition that causes inflammation and bleeding in the large intestine. The trial is designed to find out how well this medication works, any side effects that might occur, and how the body processes the medication. It involves about 110 young participants from up to 100 sites around the world and will take place over several phases, including an initial 8-week period where everyone knows they are receiving the medication, followed by a longer period where neither the participants nor the doctors will know which dose they are receiving.
To be eligible for the trial, participants need to have active UC and must not have responded well to other treatments like corticosteroids or immunosuppressants. They will need to attend regular appointments for medical check-ups, blood tests, and to complete questionnaires about their health. It's important to note that this trial may require more frequent visits and monitoring compared to standard treatments, but it also offers the chance to access a new treatment option.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.
- • Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
- Exclusion Criteria:
- • Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
- • Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina
Cordoba, , Argentina
Edegem, Antwerpen, Belgium
Leuven, Vlaams Brabant, Belgium
Curitiba, Parana, Brazil
Campinas, Sao Paulo, Brazil
Sao Paulo, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofiya, , Bulgaria
Varna, , Bulgaria
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Plzen, , Czechia
Praha, , Czechia
Bron Cedex, Rhone, France
Bordeaux, , France
Paris, , France
Paris, , France
Toulouse, , France
Athens, Attiki, Greece
Heraklion, Kriti, Greece
Debrecen, Hajdu Bihar, Hungary
Budapest, , Hungary
Florence, Firenze, Italy
Rome, Lazio, Italy
Bologna, , Italy
Kashiwa Shi, Chiba, Japan
Kurume Shi, Fukuoka, Japan
Sapporo Shi, Hokkaido, Japan
Sendai Shi, Miyagi, Japan
Izumi Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Saitama Shi, Saitama, Japan
Bunkyo Ku, Tokyo, Japan
Fucyu Shi, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Cuernavaca, Morelos, Mexico
San Pedro Garza Garcia, Nuevo Leon, Mexico
Amsterdam, , Netherlands
Groningen, , Netherlands
Torun, Kujawsko Pomorskie, Poland
Krakow, Malopolskie, Poland
Warszawa, Mazowieckie, Poland
Ferrol, A Coruna, Spain
Esplugues De Llobregat, Barcelona, Spain
Barcelona, , Spain
Taipei City, , Taiwan
Taoyuan City, , Taiwan
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Southampton, Hampshire, United Kingdom
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Birmingham, , United Kingdom
Sheffield, , United Kingdom
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Aurora, Colorado, United States
Boston, Massachusetts, United States
Mineola, New York, United States
Pittsburgh, Pennsylvania, United States
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Munich, , Germany
Torun, Kujawsko Pomorskie, Poland
Malaga, , Spain
Fuchu Shi, Tokyo, Japan
New York, New York, United States
Sheffield, , United Kingdom
Rome, Roma, Italy
Norfolk, Virginia, United States
Wilmington, Delaware, United States
Aurora, Colorado, United States
府中市, Tokyo, Japan
Fuchu City, Tokyo, Japan
Oakland, California, United States
Oakland, California, United States
Bron Cedex, Rhone, France
Christchurch, Canterbury, New Zealand
Varna, , Bulgaria
Varna, , Bulgaria
Grafton, Auckland, New Zealand
Nedlands, Western Australia, Australia
Paris, , France
Petah Tikva, Hamerkaz, Israel
Jerusalem, Yerushalayim, Israel
Debrecen, Hajdu Bihar, Hungary
Bordeaux Cedex, Gironde, France
South Brisbane, Queensland, Australia
Sheffield, England, United Kingdom
Budapest, , Hungary
Bordeaux, Gironde, France
Rome, Roma, Italy
Charlotte, North Carolina, United States
Westmead, , Australia
Saitama, , Japan
Atlanta, Georgia, United States
Taipei City, Taipei, Taiwan
Corona, California, United States
Clayton, Victoria, Australia
Chapel Hill, North Carolina, United States
Westmead, Northern Territory, Australia
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Peoria, Illinois, United States
Amsterdam, Noord Holland, Netherlands
Bordeaux, Nouvelle Aquitaine, France
Perth, Western Australia, Australia
Curitiba, Parana, Brazil
São Paulo, Sao Paulo, Brazil
Muenster, Nordrhein Westfalen, Germany
Muenchen, Saarland, Germany
London, London, City Of, United Kingdom
Campinas, Sao Paulo, Brazil
Bunkyo Ku, Tokyo, Japan
Westmead, New South Wales, Australia
Muenchen, Bayern, Germany
San Juan, , Puerto Rico
London, Greater London, United Kingdom
London, Greater London, United Kingdom
Clayton, Victoria, Australia
Mineola, New York, United States
Philadelphia, Pennsylvania, United States
Auckland, , New Zealand
Prague, Praha 5, Czechia
Pilsen, Plzen Jih, Czechia
Madison, Wisconsin, United States
Berlin, , Germany
Palo Alto, California, United States
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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