A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Study Purpose
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion criteria:
- - A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance therapy and initially responded to ustekinumab induction therapy, administered according to the local label, followed by secondary loss of response (LoR) to ustekinumab.
- - Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral
corticosteroids (for example {e.g.}, prednisone, budesonide) at a
prednisone-equivalent dose of <=40 mg/day or <=9 mg/day of budesonide, antibiotics
used as the primary treatment of Crohn's disease, or conventional immunomodulators
(i.e., azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) are
permitted providing the doses indicated are stable before baseline or have been
discontinued before baseline within the protocol defined durations
Exclusion Criteria:
- Complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab - Currently has or is suspected to have an abscess.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03782376 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen-Cilag Ltd. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen-Cilag Ltd. Clinical Trial |
Principal Investigator Affiliation | Janssen-Cilag Ltd. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Crohn Disease |
Study Website: | View Trial Website |
This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to 24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w maintenance treatment as measured by clinical response after 16 weeks of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy, patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant medications and adverse events (AEs), and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will be randomly assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab injection at baseline in a double dummy design. No participants will be treated with placebo only.
Arms
Experimental: Group 1: Ustekinumab (IV re-induction)
Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Active Comparator: Group 2: Ustekinumab (Continuous q8w SC maintenance)
Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Interventions
Drug: - Ustekinumab approximately 6 mg/kg (IV)
Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
Drug: - Placebo (SC)
Participants will receive SC injection of placebo at Week 0.
Drug: - Placebo (IV)
Participants will receive IV infusion of placebo at Week 0.
Drug: - Ustekinumab 90 mg (SC) Group 1
Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
Drug: - Ustekinumab 90 mg (SC) Group 2
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of California, San Diego
La Jolla, California, 92093
Status
Recruiting
Address
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Status
Withdrawn
Address
Medical Research Center of Connecticut
Hamden, Connecticut, 06518
Status
Recruiting
Address
Florida Research Network, LLC
Gainesville, Florida, 32605
Status
Not yet recruiting
Address
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Status
Recruiting
Address
Advent Health
Orlando, Florida, 32803
Status
Completed
Address
Florida Hospital Tampa
Tampa, Florida, 33613
Status
Not yet recruiting
Address
Emory University
Atlanta, Georgia, 30322
Status
Recruiting
Address
Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's
Atlanta, Georgia, 30342-5020
Status
Recruiting
Address
Atlanta Gastroenterology Specialists
Suwanee, Georgia, 30024
Status
Withdrawn
Address
The University Of Chicago Medicine
Chicago, Illinois, 60637
Status
Recruiting
Address
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Status
Completed
Address
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Status
Recruiting
Address
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39202
Status
Completed
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Mount Sinai School of Medicine
New York, New York, 10029
Status
Recruiting
Address
Ohio State University Hospital
Hilliard, Ohio, 43026
Status
Recruiting
Address
Oklahoma Digestive Disease Specialists
Oklahoma City, Oklahoma, 73112
Status
Not yet recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Status
Completed
Address
Texas Digestive Disease Consultants
Cedar Park, Texas, 78613
Status
Recruiting
Address
Baylor College of Medicine
Houston, Texas, 77025
Status
Recruiting
Address
Houston Methodist Hospital
Houston, Texas, 77030-2740
Status
Not yet recruiting
Address
Tyler Research Institute, LLC
Tyler, Texas, 75701
Status
Withdrawn
Address
Texas Digestive Disease Consultants
Webster, Texas, 77598
Status
Not yet recruiting
Address
Virginia Mason Medical Center
Seattle, Washington, 98101
Status
Recruiting
Address
University of Washington
Seattle, Washington, 98195
International Sites
Status
Not yet recruiting
Address
Medizinische Universität Innsbruck
Innsbruck, , 6020
Status
Withdrawn
Address
Klinikum Klagenfurt am Worthersee
Klagenfurt, , 9020
Status
Recruiting
Address
Krankenhaus der Barmherzigen Brüder
Wien, , 1020
Status
Recruiting
Address
Medizinische Universität Wien
Wien, , 1090
Status
Recruiting
Address
Hôpital Beaujon
Clichy, , 92110
Status
Recruiting
Address
CHRU de Lille - Hôpital Claude Huriez
Lille, , 59037
Status
Recruiting
Address
CHRU Montpellier - Hopital Saint-Eloi
Montpellier, , 34295
Status
Recruiting
Address
CHU Hôpital Saint Antoine
Paris cedex 12, , 75571
Status
Recruiting
Address
Hospices Civils de Lyon HCL
Pierre Bénite, , 69495
Status
Recruiting
Address
CHRU Hôpital de Pontchaillou
Rennes, , 35033
Status
Recruiting
Address
CHU de Nancy_ Hôpital Brabois
Vandoeuvre-les-Nancy, , 54511
Status
Recruiting
Address
Klinikum Augsburg
Augsburg, , D-86158
Status
Withdrawn
Address
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
Berlin-Karlshorst, , 10318
Status
Recruiting
Address
GASTRO-Studien
Berlin, , 10825
Status
Recruiting
Address
Charite - Universitatsmedizin Berlin (CCM)
Berlin, , 12203
Status
Recruiting
Address
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, , 85221
Status
Recruiting
Address
University Hospital Dresden
Dresden, , 1307
Status
Recruiting
Address
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt, , 60431
Status
Recruiting
Address
Universitätsklinikum Frankfurt/ Medizinische Klinik 1
Frankfurt, , 60590
Status
Recruiting
Address
Universitatsklinikum Freiburg
Freiburg, , 79106
Status
Recruiting
Address
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, , 06120
Status
Recruiting
Address
Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.
Hamburg, , 20251
Status
Withdrawn
Address
Asklepios Westklinikum
Hamburg, , 22559
Status
Recruiting
Address
Gastroenterologie Opernstraße
Kassel, , 34117
Status
Recruiting
Address
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, , 24105
Status
Withdrawn
Address
Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten
Leipzig, , 04105
Status
Recruiting
Address
Städtisches Klinikum Lüneburg
Lueneburg, , 21339
Status
Not yet recruiting
Address
Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
Magdeburg, , 39120
Status
Recruiting
Address
Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, , 68167
Status
Recruiting
Address
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , 32423
Status
Recruiting
Address
Klinikum der Universität München
München, , 81377
Status
Recruiting
Address
Praxis Dr. med. Ulf Helwig
Oldenburg, , 26123
Status
Recruiting
Address
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, , 66111
Status
Recruiting
Address
Universitaetsklinik Tuebingen
Tübingen, , 72076
Status
Recruiting
Address
Universitätsklinikum Ulm, Klinik für Innere Medizin II
Ulm, , 89081
Status
Recruiting
Address
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, , 20122
Status
Not yet recruiting
Address
Ospedale Villa Sofia-Cervello
Palermo, , 90146
Status
Not yet recruiting
Address
Azienda Ospedaliera G.Salvini Ospedale di Rho
RHO, ,
Status
Recruiting
Address
Fondazione Policlinico Gemelli Università Cattolica
Roma, , 168
Status
Recruiting
Address
Istituto Clinico Humanitas
Rozzano, , 20089
Status
Not yet recruiting
Address
AO Ordine Mauriziano
Torino, , 10128
Status
Recruiting
Address
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 AC
Status
Withdrawn
Address
Amphia Ziekenhuis
Breda, , 4818 CK
Status
Recruiting
Address
Leiden University Medical Center
Leiden, , 2333 ZA
Status
Completed
Address
Maastricht Universitair Medisch Centrum
Maastricht, , 6229 HX
Status
Recruiting
Address
Radboudumc
Nijmegen, , 6525 GA
Status
Recruiting
Address
Erasmus MC
Rotterdam, , 3015 GD
Status
Recruiting
Address
Sint Franciscus Gasthuis
Rotterdam, , 3045 PM
Status
Recruiting
Address
Hosp. Univ. Fundacion Alcorcon
Alcorcón, , 28922
Status
Recruiting
Address
Hosp. Arquitecto Marcide
Ferrol, , 15405
Status
Recruiting
Address
Hosp. Gral. Univ. Gregorio Marañon
Madrid, , 28007
Status
Recruiting
Address
Hosp. Univ. La Paz
Madrid, , 28046
Status
Recruiting
Address
Hosp. Univ. Virgen de La Arrixaca
Murcia, , 30120
Status
Recruiting
Address
Hosp. Virgen de La Victoria
Málaga, , 29010
Status
Recruiting
Address
Hosp. de Navarra
Pamplona, , 31008
Status
Recruiting
Address
Hosp. Montecelo
Pontevedra, , 36071
Status
Recruiting
Address
Corporacio Sanitari Parc Tauli
Sabadell, , 08208
Status
Recruiting
Address
Hosp. Clinico Univ. de Salamanca
Salamanca, , 37007
Status
Recruiting
Address
Hosp. Univ. Marques de Valdecilla
Santander, , 39008
Status
Recruiting
Address
Hosp. Clinico Univ. de Valencia
Valencia, , 46010
Status
Recruiting
Address
Hosp. Alvaro Cunqueiro
Vigo, , 36312
Status
Recruiting
Address
Hosp. Univ. Miguel Servet
Zaragoza, , 50009
Status
Recruiting
Address
Gastromottagningen
Malmö, , 20502
Status
Recruiting
Address
Gastromottagningen
Stockholm, , 18288
Status
Recruiting
Address
Pennine Acute Hospitals-Fairfield General Hospital
Bury, , BL9 7TD
Status
Not yet recruiting
Address
Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
Cheltenham, , GL53 7AN
Status
Not yet recruiting
Address
Royal Devon & Exeter Hospital
Exeter, , EX2 5DW
Status
Not yet recruiting
Address
St. Mark's Hospital
Harrow, , HA1 3UJ
Status
Not yet recruiting
Address
King's College Hospital NHS Foundation Trust
London, , SE5 9RS
Status
Not yet recruiting
Address
St George's Hospital
London, , SW17 OQT
Status
Not yet recruiting
Address
Southampton University Hospitals NHS Trust
Southampton, , SO16 6YD
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