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
More Inclusion & Exclusion Criteria

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.
Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and <=450 with at least one of the following: Elevated C-reactive protein (CRP) (>3.0 milligram per liter [mg/L]); and/or elevated Fecal calprotectin (FeCa) >250 milligram per kilogram [mg/kg]); and/or endoscopy (performed less than or equal to (<=) 3 months before baseline) with evidence of active Crohn's disease, (defined as one or more ulcerations in the ileum and/or colon)
  • - 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.
Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified - Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline - A draining (i.e., functioning) stoma or ostomy - Received any off-label use of ustekinumab, including additional intravenous (IV) re-induction or shortened frequency of subcutaneous dose administration after the initial weight-tiered based IV induction dose of ustekinumab

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
Additional Details

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 & Interventions

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.

University of California, San Diego, La Jolla, California

Status

Recruiting

Address

University of California, San Diego

La Jolla, California, 92093

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Medical Research Center of Connecticut, Hamden, Connecticut

Status

Withdrawn

Address

Medical Research Center of Connecticut

Hamden, Connecticut, 06518

Florida Research Network, LLC, Gainesville, Florida

Status

Recruiting

Address

Florida Research Network, LLC

Gainesville, Florida, 32605

Mayo Clinic Jacksonville, Jacksonville, Florida

Status

Not yet recruiting

Address

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

Advent Health, Orlando, Florida

Status

Recruiting

Address

Advent Health

Orlando, Florida, 32803

Florida Hospital Tampa, Tampa, Florida

Status

Completed

Address

Florida Hospital Tampa

Tampa, Florida, 33613

Emory University, Atlanta, Georgia

Status

Not yet recruiting

Address

Emory University

Atlanta, Georgia, 30322

Atlanta, Georgia

Status

Not yet recruiting

Address

Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's

Atlanta, Georgia, 30342-5020

Atlanta Gastroenterology Specialists, Suwanee, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists

Suwanee, Georgia, 30024

The University Of Chicago Medicine, Chicago, Illinois

Status

Withdrawn

Address

The University Of Chicago Medicine

Chicago, Illinois, 60637

Lexington, Kentucky

Status

Not yet recruiting

Address

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536

Chevy Chase Clinical Research, Chevy Chase, Maryland

Status

Recruiting

Address

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815

Brigham & Women's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Brigham & Women's Hospital

Boston, Massachusetts, 02115

University of Mississippi Medical Center, Jackson, Mississippi

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39202

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Mount Sinai School of Medicine, New York, New York

Status

Recruiting

Address

Mount Sinai School of Medicine

New York, New York, 10029

Ohio State University Hospital, Columbus, Ohio

Status

Not yet recruiting

Address

Ohio State University Hospital

Columbus, Ohio, 43210

Oklahoma Digestive Disease Specialists, Oklahoma City, Oklahoma

Status

Recruiting

Address

Oklahoma Digestive Disease Specialists

Oklahoma City, Oklahoma, 73112

Medical University of South Carolina, Charleston, South Carolina

Status

Not yet recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Texas Digestive Disease Consultants, Cedar Park, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

Cedar Park, Texas, 78613

Baylor College of Medicine, Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine

Houston, Texas, 77025

Houston Methodist Hospital, Houston, Texas

Status

Recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030-2740

Texas Digestive Disease Consultants, Webster, Texas

Status

Withdrawn

Address

Texas Digestive Disease Consultants

Webster, Texas, 77598

Virginia Mason Medical Center, Seattle, Washington

Status

Not yet recruiting

Address

Virginia Mason Medical Center

Seattle, Washington, 98101

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195

International Sites

Medizinische Universität Innsbruck, Innsbruck, Austria

Status

Not yet recruiting

Address

Medizinische Universität Innsbruck

Innsbruck, , 6020

Klinikum Klagenfurt am Worthersee, Klagenfurt, Austria

Status

Withdrawn

Address

Klinikum Klagenfurt am Worthersee

Klagenfurt, , 9020

Krankenhaus der Barmherzigen Brüder, Wien, Austria

Status

Recruiting

Address

Krankenhaus der Barmherzigen Brüder

Wien, , 1020

Medizinische Universität Wien, Wien, Austria

Status

Not yet recruiting

Address

Medizinische Universität Wien

Wien, , 1090

Hôpital Beaujon, Clichy, France

Status

Recruiting

Address

Hôpital Beaujon

Clichy, , 92110

CHRU de Lille - Hôpital Claude Huriez, Lille, France

Status

Recruiting

Address

CHRU de Lille - Hôpital Claude Huriez

Lille, , 59037

CHRU Montpellier - Hopital Saint-Eloi, Montpellier, France

Status

Recruiting

Address

CHRU Montpellier - Hopital Saint-Eloi

Montpellier, , 34295

CHU Hôpital Saint Antoine, Paris cedex 12, France

Status

Recruiting

Address

CHU Hôpital Saint Antoine

Paris cedex 12, , 75571

Hospices Civils de Lyon HCL, Pierre Bénite, France

Status

Recruiting

Address

Hospices Civils de Lyon HCL

Pierre Bénite, , 69495

CHRU Hôpital de Pontchaillou, Rennes, France

Status

Recruiting

Address

CHRU Hôpital de Pontchaillou

Rennes, , 35033

CHU de Nancy_ Hôpital Brabois, Vandoeuvre-les-Nancy, France

Status

Recruiting

Address

CHU de Nancy_ Hôpital Brabois

Vandoeuvre-les-Nancy, , 54511

Klinikum Augsburg, Augsburg, Germany

Status

Recruiting

Address

Klinikum Augsburg

Augsburg, , D-86158

Berlin-Karlshorst, Germany

Status

Withdrawn

Address

Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Berlin-Karlshorst, , 10318

GASTRO-Studien, Berlin, Germany

Status

Recruiting

Address

GASTRO-Studien

Berlin, , 10825

Berlin, Germany

Status

Recruiting

Address

Charite - Universitatsmedizin Berlin (CCM)

Berlin, , 12203

Dachau, Germany

Status

Recruiting

Address

Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, , 85221

University Hospital Dresden, Dresden, Germany

Status

Recruiting

Address

University Hospital Dresden

Dresden, , 1307

Frankfurt, Germany

Status

Recruiting

Address

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

Frankfurt, , 60431

Frankfurt, Germany

Status

Recruiting

Address

Universitätsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, , 60590

Universitatsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitatsklinikum Freiburg

Freiburg, , 79106

Halle, Germany

Status

Recruiting

Address

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, , 06120

Hamburg, Germany

Status

Recruiting

Address

Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

Hamburg, , 20251

Asklepios Westklinikum, Hamburg, Germany

Status

Withdrawn

Address

Asklepios Westklinikum

Hamburg, , 22559

Gastroenterologie Opernstraße, Kassel, Germany

Status

Recruiting

Address

Gastroenterologie Opernstraße

Kassel, , 34117

Kiel, Germany

Status

Recruiting

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

Leipzig, Germany

Status

Withdrawn

Address

Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten

Leipzig, , 04105

Städtisches Klinikum Lüneburg, Lueneburg, Germany

Status

Recruiting

Address

Städtisches Klinikum Lüneburg

Lueneburg, , 21339

Magdeburg, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Otto-von-Guericke-Universität Magdeburg

Magdeburg, , 39120

Mannheim, Germany

Status

Recruiting

Address

Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, , 68167

Minden, Germany

Status

Recruiting

Address

Gastroenterologische Gemeinschaftspraxis Minden

Minden, , 32423

Klinikum der Universität München, München, Germany

Status

Not yet recruiting

Address

Klinikum der Universität München

München, , 81377

Praxis Dr. med. Ulf Helwig, Oldenburg, Germany

Status

Recruiting

Address

Praxis Dr. med. Ulf Helwig

Oldenburg, , 26123

Saarbrücken, Germany

Status

Recruiting

Address

Zentrum für Gastroenterologie Saar MVZ GmbH

Saarbrücken, , 66111

Universitaetsklinik Tuebingen, Tübingen, Germany

Status

Recruiting

Address

Universitaetsklinik Tuebingen

Tübingen, , 72076

Ulm, Germany

Status

Recruiting

Address

Universitätsklinikum Ulm, Klinik für Innere Medizin II

Ulm, , 89081

Milano, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, , 20122

Ospedale Villa Sofia-Cervello, Palermo, Italy

Status

Not yet recruiting

Address

Ospedale Villa Sofia-Cervello

Palermo, , 90146

RHO, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera G.Salvini Ospedale di Rho

RHO, ,

Roma, Italy

Status

Not yet recruiting

Address

Fondazione Policlinico Gemelli Università Cattolica

Roma, , 168

Istituto Clinico Humanitas, Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, , 20089

AO Ordine Mauriziano, Torino, Italy

Status

Not yet recruiting

Address

AO Ordine Mauriziano

Torino, , 10128

Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

Status

Recruiting

Address

Onze Lieve Vrouwe Gasthuis

Amsterdam, , 1091 AC

Amphia Ziekenhuis, Breda, Netherlands

Status

Withdrawn

Address

Amphia Ziekenhuis

Breda, , 4818 CK

Leiden University Medical Center, Leiden, Netherlands

Status

Recruiting

Address

Leiden University Medical Center

Leiden, , 2333 ZA

Maastricht Universitair Medisch Centrum, Maastricht, Netherlands

Status

Completed

Address

Maastricht Universitair Medisch Centrum

Maastricht, , 6229 HX

Radboudumc, Nijmegen, Netherlands

Status

Recruiting

Address

Radboudumc

Nijmegen, , 6525 GA

Erasmus MC, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus MC

Rotterdam, , 3015 GD

Sint Franciscus Gasthuis, Rotterdam, Netherlands

Status

Recruiting

Address

Sint Franciscus Gasthuis

Rotterdam, , 3045 PM

Hosp. Univ. Fundacion Alcorcon, Alcorcón, Spain

Status

Recruiting

Address

Hosp. Univ. Fundacion Alcorcon

Alcorcón, , 28922

Hosp. Arquitecto Marcide, Ferrol, Spain

Status

Recruiting

Address

Hosp. Arquitecto Marcide

Ferrol, , 15405

Hosp. Gral. Univ. Gregorio Marañon, Madrid, Spain

Status

Recruiting

Address

Hosp. Gral. Univ. Gregorio Marañon

Madrid, , 28007

Hosp. Univ. La Paz, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. La Paz

Madrid, , 28046

Hosp. Univ. Virgen de La Arrixaca, Murcia, Spain

Status

Recruiting

Address

Hosp. Univ. Virgen de La Arrixaca

Murcia, , 30120

Hosp. Virgen de La Victoria, Málaga, Spain

Status

Recruiting

Address

Hosp. Virgen de La Victoria

Málaga, , 29010

Hosp. de Navarra, Pamplona, Spain

Status

Recruiting

Address

Hosp. de Navarra

Pamplona, , 31008

Hosp. Montecelo, Pontevedra, Spain

Status

Recruiting

Address

Hosp. Montecelo

Pontevedra, , 36071

Corporacio Sanitari Parc Tauli, Sabadell, Spain

Status

Recruiting

Address

Corporacio Sanitari Parc Tauli

Sabadell, , 08208

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007

Hosp. Univ. Marques de Valdecilla, Santander, Spain

Status

Recruiting

Address

Hosp. Univ. Marques de Valdecilla

Santander, , 39008

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46010

Hosp. Alvaro Cunqueiro, Vigo, Spain

Status

Recruiting

Address

Hosp. Alvaro Cunqueiro

Vigo, , 36312

Hosp. Univ. Miguel Servet, Zaragoza, Spain

Status

Recruiting

Address

Hosp. Univ. Miguel Servet

Zaragoza, , 50009

Gastromottagningen, Malmö, Sweden

Status

Recruiting

Address

Gastromottagningen

Malmö, , 20502

Gastromottagningen, Stockholm, Sweden

Status

Recruiting

Address

Gastromottagningen

Stockholm, , 18288

Bury, United Kingdom

Status

Not yet recruiting

Address

Pennine Acute Hospitals-Fairfield General Hospital

Bury, , BL9 7TD

Cheltenham, United Kingdom

Status

Not yet recruiting

Address

Gloucestershire Hospitals NHS Foundation Trust - Cheltenham

Cheltenham, , GL53 7AN

Royal Devon & Exeter Hospital, Exeter, United Kingdom

Status

Not yet recruiting

Address

Royal Devon & Exeter Hospital

Exeter, , EX2 5DW

St. Mark's Hospital, Harrow, United Kingdom

Status

Not yet recruiting

Address

St. Mark's Hospital

Harrow, , HA1 3UJ

London, United Kingdom

Status

Not yet recruiting

Address

King's College Hospital NHS Foundation Trust

London, , SE5 9RS

St George's Hospital, London, United Kingdom

Status

Not yet recruiting

Address

St George's Hospital

London, , SW17 OQT

Southampton, United Kingdom

Status

Not yet recruiting

Address

Southampton University Hospitals NHS Trust

Southampton, , SO16 6YD

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