A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Status: Recruiting
Location: See all (86) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Arkansas Children's Hospital /ID# 250106
RECRUITING
Little Rock
Arizona
Phoenix Children's Hospital /ID# 250135
RECRUITING
Phoenix
California
Kindred Medical Institute - Corona /ID# 255484
RECRUITING
Corona
UCSF Benioff Children's Hospital - Oakland /ID# 255067
RECRUITING
Oakland
Lucile Packard Children's Hospital /ID# 258430
RECRUITING
Palo Alto
Colorado
Childrens Hospital Colorado - Aurora /ID# 250110
RECRUITING
Aurora
Delaware
Nemours/Alfred duPont Hospital for Children /ID# 255483
COMPLETED
Wilmington
Georgia
Childrens Healthcare of Atlanta - Center for Advanced Pediatrics /ID# 255069
RECRUITING
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 254505
RECRUITING
Chicago
OSF St. Francis Medical Center /ID# 256968
RECRUITING
Peoria
Massachusetts
Boston Children's Hospital /ID# 250108
RECRUITING
Boston
Massachusetts General Hospital /ID# 250142
RECRUITING
Boston
North Carolina
Univ NC Chapel Hill /ID# 254541
RECRUITING
Chapel Hill
Levine Children's Hospital /ID# 250131
RECRUITING
Charlotte
New York
NYU Langone Hospital - Long Island /ID# 250136
RECRUITING
Mineola
The Mount Sinai Hospital /ID# 250141
RECRUITING
New York
Ohio
UH Cleveland Medical Center /ID# 250134
RECRUITING
Cleveland
Pennsylvania
Children's Hospital of Philadelphia - Main /ID# 258773
RECRUITING
Philadelphia
Virginia
Children's Specialty Group /ID# 256966
RECRUITING
Norfolk
Wisconsin
University of Wisconsin - Madison /ID# 250632
RECRUITING
Madison
Other Locations
Australia
Monash Health - Monash Medical Centre /ID# 254726
RECRUITING
Clayton
Perth Children'S Hospital /ID# 254727
RECRUITING
Perth
Queensland Children's Hospital /ID# 261032
RECRUITING
South Brisbane
Children's Hospital at Westmead /ID# 255556
RECRUITING
Westmead
Belgium
Universitair Ziekenhuis Antwerpen /ID# 251184
RECRUITING
Edegem
Universitair Ziekenhuis Leuven /ID# 251185
RECRUITING
Leuven
Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 251912
RECRUITING
Campinas
Hospital Pequeno Príncipe /ID# 251911
RECRUITING
Curitiba
Rocco & Nazato Servicos Medicos /ID# 251910
RECRUITING
São Paulo
Bulgaria
UMHAT Sveti Georgi /ID# 251949
RECRUITING
Plovdiv
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251285
RECRUITING
Sofia
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 251948
RECRUITING
Varna
Canada
Alberta Health Services /ID# 252088
RECRUITING
Edmonton
IWK Health Center /ID# 250943
RECRUITING
Halifax
Hospital for Sick Children /ID# 250945
RECRUITING
Toronto
BC Children's Hospital /ID# 250947
RECRUITING
Vancouver
France
CHU Bordeaux - Hopital Pellegrin /ID# 253182
RECRUITING
Bordeaux
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 251502
RECRUITING
Bron
AP-HP - Hopital Necker /ID# 251658
RECRUITING
Paris
Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 252069
COMPLETED
Paris
CHU Toulouse - Hopital Paule de Viguier /ID# 252070
RECRUITING
Toulouse
Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 251434
RECRUITING
Berlin
Klinikum St. Georg gGmbH /ID# 262481
RECRUITING
Leipzig
Dr. von Haunerschen Kinderspital /ID# 251440
RECRUITING
Munich
Universitaetsklinikum Muenster /ID# 256763
RECRUITING
Münster
Greece
Agia Sofia Hospital /ID# 250697
RECRUITING
Athens
University General Hospital of Heraklion PA.G.N.I /ID# 250696
RECRUITING
Heraklion
Hungary
Semmelweis Egyetem /ID# 251083
RECRUITING
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 251835
RECRUITING
Debrecen
Israel
Shaare Zedek Medical Center /ID# 254832
RECRUITING
Jerusalem
Schneider Children's Medical Center /ID# 254833
RECRUITING
Petah Tikva
Italy
Ospedale Maggiore Carlo Alberto Pizzardi /ID# 251626
RECRUITING
Bologna
Azienda Ospedaliero Universitaria Meyer /ID# 251624
RECRUITING
Florence
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 251625
RECRUITING
Rome
Japan
Institute of Science Tokyo Hospital /ID# 251929
RECRUITING
Bunkyo-ku
Tokyo Metropolitan Children's Medical Center /ID# 252477
RECRUITING
Fuchu-shi
Osaka Women's and Children's Hospital /ID# 252397
RECRUITING
Izumi-shi
Tsujinaka Hospital - Kashiwanoha /ID# 251930
RECRUITING
Kashiwa-shi
Kurume University Hospital /ID# 251927
RECRUITING
Kurume-shi
Osaka General Medical Center /ID# 253678
RECRUITING
Osaka
Saitama Children's Medical Center /ID# 252362
RECRUITING
Saitama-shi
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 251928
RECRUITING
Sapporo
Miyagi Children's Hospital /ID# 251931
RECRUITING
Sendai
National Center For Child Health And Development /ID# 251926
RECRUITING
Setagaya City
Mexico
Servicios de Oncologia Medica Integral SA de CV /ID# 252974
RECRUITING
San Pedro Garza García
Netherlands
Amsterdam UMC, locatie AMC /ID# 250845
RECRUITING
Amsterdam
Universitair Medisch Centrum Groningen /ID# 252003
RECRUITING
Groningen
New Zealand
Starship Child Health /ID# 254702
RECRUITING
Auckland
Christchurch Hospital. /ID# 254703
RECRUITING
Christchurch
Poland
Gastromed Sp. z o.o /ID# 251290
RECRUITING
Torun
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 251289
RECRUITING
Warsaw
Puerto Rico
Clinical Research Puerto Rico /ID# 266477
RECRUITING
San Juan
Republic of Korea
Kyungpook National University Chilgok Hospital /ID# 252663
RECRUITING
Daegu
Samsung Medical Center /ID# 252023
RECRUITING
Seoul
Seoul National University Hospital /ID# 252024
RECRUITING
Seoul
Spain
Hospital Universitario Vall de Hebron /ID# 252104
COMPLETED
Barcelona
Hospital Sant Joan de Deu /ID# 251194
RECRUITING
Esplugues De Llobregat
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 252105
RECRUITING
Ferrol
Hospital Regional Universitario de Malaga /ID# 251193
RECRUITING
Málaga
Taiwan
National Taiwan University Hospital /ID# 251650
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 251654
RECRUITING
Taoyuan
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 253072
RECRUITING
Birmingham
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251917
RECRUITING
London
Great Ormond Street Children's Hospital /ID# 252126
RECRUITING
London
Sheffield Children's Hospital NHS Foundation Trust /ID# 251600
RECRUITING
Sheffield
University Hospital Southampton NHS Foundation Trust /ID# 252097
RECRUITING
Southampton
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2033-10
Participants
Target number of participants: 110
Treatments
Experimental: Period 1- Open Label Induction Phase
All participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.
Experimental: Period 1- Double Blind Maintenance Phase
Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose B or Dose C for 44 weeks based on body weight.
Experimental: Period 2- Open Label Long Term Extension Phase Arm A
Clinical non-responders outside of US after Period 1 induction phase will receive upadacitinib Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib Dose B daily for up to 252 weeks in OLE period 2.
Experimental: Period 2- Open Label Long Term Extension Phase Arm B
Clinical non-responders in US after Period 1 induction phase or clinical responders with loss of response during maintenance phase will receive upadacitinib Dose B daily for up to 260 weeks in OLE Period 2.
Experimental: Period 2- Long Term Extension Phase Arm C
Clinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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