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Active (not recruiting) Phase 3 NCT05782907

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.

Phase 3 – large-scale trial before approval
Conditions: Ulcerative Colitis

Sponsor: AbbVie

trial.available_in: БГ
Overview
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can participate
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.
Locations 23
Australia (1)
Children's Hospital at Westmead /ID# 255556
Westmead , New South Wales
Belgium (1)
Universitair Ziekenhuis Antwerpen /ID# 251184
Edegem , Antwerpen
Brazil (1)
Hospital Pequeno Príncipe /ID# 251911
Curitiba , Paraná
Bulgaria (1)
UMHAT Sveti Georgi /ID# 251949
Plovdiv
Canada (1)
Alberta Health Services /ID# 252088
Edmonton , Alberta
Czech Republic (1)
Fakultní Nemocnice Plzeň-Lochotín /ID# 253284
Pilsen , Plzen-jih
France (1)
CHU Bordeaux - Hopital Pellegrin /ID# 253182
Bordeaux , New Aquitaine
Germany (1)
Dr. von Haunerschen Kinderspital /ID# 251440
Munich , Bavaria
Greece (1)
Agia Sofia Hospital /ID# 250697
Athens , Attica
Hungary (1)
Debreceni Egyetem-Klinikai Kozpont /ID# 251835
Debrecen , Hajdú-Bihar
Israel (1)
Schneider Children's Medical Center /ID# 254833
Petah Tikva , Central District
Italy (1)
Azienda Ospedaliero Universitaria Meyer /ID# 251624
Florence , Firenze
Japan (1)
Tsujinaka Hospital - Kashiwanoha /ID# 251930
Kashiwa-shi , Chiba
Mexico (1)
Servicios de Oncologia Medica Integral SA de CV /ID# 252974
San Pedro Garza García , Nuevo León
Netherlands (1)
Amsterdam UMC, locatie AMC /ID# 250845
Amsterdam , North Holland
New Zealand (1)
Christchurch Hospital. /ID# 254703
Christchurch , Canterbury
Poland (1)
Gastromed Sp. z o.o /ID# 251290
Torun , Kuyavian-Pomeranian Voivodeship
Puerto Rico (1)
Clinical Research Puerto Rico /ID# 266477
San Juan
South Korea (1)
Seoul National University Hospital /ID# 252024
Seoul , Seoul Teugbyeolsi
Spain (1)
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 252105
Ferrol , A Coruna
Taiwan (1)
National Taiwan University Hospital /ID# 251650
Taipei City , Taipei
United Kingdom (1)
Sheffield Children's Hospital NHS Foundation Trust /ID# 251600
Sheffield , England
United States (1)
Phoenix Children's Hospital /ID# 250135
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
06.11.2023
Completion date
01.10.2033
Registry ID
NCT05782907
Source
anzctr
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