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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
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 - 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 within the 3 months before baseline) with evidence of active Crohn's disease during the current disease flare (that is [i.e.], 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 of the following prescribed medications or therapies within a specified period including any off-label use of ustekinumab, additional IV re-induction or shortened frequency of subcutaneous dose administration, after the initial weight-tiered based IV induction dose of ustekinumab

Trial Details

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.

Trial ID:
NCT03782376

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
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Janssen-Cilag Ltd.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Janssen-Cilag Ltd. Clinical Trial
Principal Investigator Affiliation Janssen-Cilag Ltd.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Germany, Netherlands, Spain, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
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.

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

Not yet recruiting

Address

University of California, San Diego

La Jolla, California, 92093

Site Contact

844-434-4210

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Site Contact

844-434-4210

Medical Research Center of Connecticut, Hamden, Connecticut

Status

Withdrawn

Address

Medical Research Center of Connecticut

Hamden, Connecticut, 06518

Site Contact

844-434-4210

Florida Hospital, Orlando, Florida

Status

Not yet recruiting

Address

Florida Hospital

Orlando, Florida, 32803

Site Contact

844-434-4210

Florida Hospital Tampa, Tampa, Florida

Status

Not yet recruiting

Address

Florida Hospital Tampa

Tampa, Florida, 33613

Site Contact

844-434-4210

Atlanta, Georgia

Status

Not yet recruiting

Address

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

Atlanta, Georgia, 30342-5020

Site Contact

844-434-4210

Atlanta Gastroenterology Specialists, Suwanee, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists

Suwanee, Georgia, 30024

Site Contact

844-434-4210

The University Of Chicago Medicine, Chicago, Illinois

Status

Not yet recruiting

Address

The University Of Chicago Medicine

Chicago, Illinois, 60637

Site Contact

844-434-4210

Brigham & Women's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Brigham & Women's Hospital

Boston, Massachusetts, 02115

Site Contact

844-434-4210

Washington University School of Medicine, Saint Louis, Missouri

Status

Not yet recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

844-434-4210

Mount Sinai School of Medicine, New York, New York

Status

Not yet recruiting

Address

Mount Sinai School of Medicine

New York, New York, 10029

Site Contact

844-434-4210

Oklahoma Digestive Disease Specialists, Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

Oklahoma Digestive Disease Specialists

Oklahoma City, Oklahoma, 73112

Site Contact

844-434-4210

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Site Contact

844-434-4210

Houston Methodist Hospital, Houston, Texas

Status

Not yet recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030-2740

Site Contact

844-434-4210

Texas Digestive Disease Consultants, Webster, Texas

Status

Not yet recruiting

Address

Texas Digestive Disease Consultants

Webster, Texas, 77598

Site Contact

844-434-4210

University of Washington, Seattle, Washington

Status

Not yet recruiting

Address

University of Washington

Seattle, Washington, 98195

Site Contact

844-434-4210

International Sites

Klinikum Augsburg, Augsburg, Germany

Status

Not yet recruiting

Address

Klinikum Augsburg

Augsburg, , D-86158

Site Contact

844-434-4210

Berlin-Karlshorst, Germany

Status

Not yet recruiting

Address

Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Berlin-Karlshorst, , 10318

Site Contact

844-434-4210

GASTRO-Studien, Berlin, Germany

Status

Not yet recruiting

Address

GASTRO-Studien

Berlin, , 10825

Site Contact

844-434-4210

Berlin, Germany

Status

Not yet recruiting

Address

Charite - Universitatsmedizin Berlin (CCM)

Berlin, , 12203

Site Contact

844-434-4210

Dachau, Germany

Status

Not yet recruiting

Address

Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, , 85221

Site Contact

844-434-4210

University Hospital Dresden, Dresden, Germany

Status

Not yet recruiting

Address

University Hospital Dresden

Dresden, , 01307

Site Contact

844-434-4210

Frankfurt, Germany

Status

Not yet recruiting

Address

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

Frankfurt, , 60431

Site Contact

844-434-4210

Frankfurt, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, , 60590

Site Contact

844-434-4210

Universitatsklinikum Freiburg, Freiburg, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Freiburg

Freiburg, , 79106

Site Contact

844-434-4210

Halle, Germany

Status

Not yet recruiting

Address

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, , 06120

Site Contact

844-434-4210

Hamburg, Germany

Status

Not yet recruiting

Address

Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

Hamburg, , 20251

Site Contact

844-434-4210

Asklepios Westklinikum, Hamburg, Germany

Status

Not yet recruiting

Address

Asklepios Westklinikum

Hamburg, , 22559

Site Contact

844-434-4210

Gastroenterologie Opernstraße, Kassel, Germany

Status

Not yet recruiting

Address

Gastroenterologie Opernstraße

Kassel, , 34117

Site Contact

844-434-4210

Kiel, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

Site Contact

844-434-4210

Leipzig, Germany

Status

Not yet recruiting

Address

Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten

Leipzig, , 04229

Site Contact

844-434-4210

Städtisches Klinikum Lüneburg, Lueneburg, Germany

Status

Not yet recruiting

Address

Städtisches Klinikum Lüneburg

Lueneburg, , 21339

Site Contact

844-434-4210

Mannheim, Germany

Status

Not yet recruiting

Address

Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, , 68167

Site Contact

844-434-4210

Minden, Germany

Status

Not yet recruiting

Address

Gastroenterologische Gemeinschaftspraxis Minden

Minden, , 32423

Site Contact

844-434-4210

Saarbrücken, Germany

Status

Not yet recruiting

Address

Zentrum für Gastroenterologie Saar MVZ GmbH

Saarbrücken, , 66111

Site Contact

844-434-4210

Universitaetsklinik Tuebingen, Tübingen, Germany

Status

Not yet recruiting

Address

Universitaetsklinik Tuebingen

Tübingen, , 72076

Site Contact

844-434-4210

Ulm, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Ulm, Klinik für Innere Medizin II

Ulm, , 89081

Site Contact

844-434-4210

Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

Status

Not yet recruiting

Address

Onze Lieve Vrouwe Gasthuis

Amsterdam, , 1091 AC

Site Contact

844-434-4210

Amphia Ziekenhuis, Breda, Netherlands

Status

Not yet recruiting

Address

Amphia Ziekenhuis

Breda, , 4818 CK

Site Contact

844-434-4210

Leiden University Medical Center, Leiden, Netherlands

Status

Not yet recruiting

Address

Leiden University Medical Center

Leiden, , 2333 ZA

Site Contact

844-434-4210

Maastricht Universitair Medisch Centrum, Maastricht, Netherlands

Status

Not yet recruiting

Address

Maastricht Universitair Medisch Centrum

Maastricht, , 6229 HX

Site Contact

844-434-4210

Radboudumc, Nijmegen, Netherlands

Status

Not yet recruiting

Address

Radboudumc

Nijmegen, , 6525 GA

Site Contact

844-434-4210

Erasmus MC, Rotterdam, Netherlands

Status

Not yet recruiting

Address

Erasmus MC

Rotterdam, , 3015 GD

Site Contact

844-434-4210

Sint Franciscus Gasthuis, Rotterdam, Netherlands

Status

Not yet recruiting

Address

Sint Franciscus Gasthuis

Rotterdam, , 3045 PM

Site Contact

844-434-4210

Hosp. Univ. Fundacion Alcorcon, Alcorcón, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Fundacion Alcorcon

Alcorcón, , 28922

Site Contact

844-434-4210

Hosp. Arquitecto Marcide, Ferrol, Spain

Status

Not yet recruiting

Address

Hosp. Arquitecto Marcide

Ferrol, , 15405

Site Contact

844-434-4210

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

Status

Not yet recruiting

Address

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , 28007

Site Contact

844-434-4210

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

Status

Not yet recruiting

Address

Hosp. Univ. Virgen de La Arrixaca

Murcia, , 30120

Site Contact

844-434-4210

Hosp. Virgen de La Victoria, Málaga, Spain

Status

Not yet recruiting

Address

Hosp. Virgen de La Victoria

Málaga, , 29010

Site Contact

844-434-4210

Hosp. de Navarra, Pamplona, Spain

Status

Not yet recruiting

Address

Hosp. de Navarra

Pamplona, , 31008

Site Contact

844-434-4210

Hosp. Montecelo, Pontevedra, Spain

Status

Not yet recruiting

Address

Hosp. Montecelo

Pontevedra, , 36071

Site Contact

844-434-4210

Corporacio Sanitari Parc Tauli, Sabadell, Spain

Status

Not yet recruiting

Address

Corporacio Sanitari Parc Tauli

Sabadell, , 08208

Site Contact

844-434-4210

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Not yet recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007

Site Contact

844-434-4210

Hosp. Univ. Marques de Valdecilla, Santander, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Marques de Valdecilla

Santander, , 39008

Site Contact

844-434-4210

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Not yet recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46010

Site Contact

844-434-4210

Hosp. Alvaro Cunqueiro, Vigo, Spain

Status

Not yet recruiting

Address

Hosp. Alvaro Cunqueiro

Vigo, , 36312

Site Contact

844-434-4210

Hosp. Univ. Miguel Servet, Zaragoza, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Miguel Servet

Zaragoza, , 50009

Site Contact

844-434-4210

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