A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease (POWER)

April 25, 2025 updated by: Janssen-Cilag Ltd.

A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Medizinische Universitaet Wien
      • Wien, Austria, 1020
        • Krankenhaus der Barmherzigen Brüder
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-gastroenterologie HK, s.r.o.
      • Praha 9, Czechia, 190 00
        • ISCARE a.s.
  • France
      • Clichy, France, 92110
        • Hopital Beaujon
      • Lille, France, 59037
        • CHRU de Lille Hopital Claude Huriez
      • Montpellier, France, 34295
        • CHRU Montpellier - Hopital Saint-Eloi
      • Paris cedex 12, France, 75571
        • CHU Hopital Saint Antoine
      • Pierre Bénite, France, 69495
        • Hospices Civils de Lyon HCL
      • Rennes, France, 35033
        • CHRU Hopital de Pontchaillou
      • Vandoeuvre-les-Nancy, France, 54511
        • CHU de Nancy_ Hopital Brabois
  • Germany
      • Augsburg, Germany, D-86158
        • Klinikum Augsburg
      • Berlin, Germany, 10825
        • GASTRO-Studien
      • Berlin, Germany, 12203
        • Charite - Universitaetsmedizin Berlin (CCM)
      • Dachau, Germany, 85221
        • Medizinisches Versorgungszentrum (MVZ) Dachau
      • Dresden, Germany, 1307
        • University Hospital Dresden
      • Frankfurt, Germany, 60431
        • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt/ Medizinische Klinik 1
      • Freiburg, Germany, 79106
        • Universitatsklinikum Freiburg
      • Halle, Germany, 06120
        • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
      • Hamburg, Germany, 20251
        • Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.
      • Kassel, Germany, 34117
        • Gastroenterologie Opernstrasse
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig Holstein Kiel
      • Lueneburg, Germany, 21339
        • Staedtisches Klinikum Lueneburg
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
      • Mannheim, Germany, 68167
        • Medizinische Fakultät Mannheim der Universität Heidelberg
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Muenchen, Germany, 81377
        • Klinikum der Universitaet Muenchen
      • Oldenburg, Germany, 26123
        • Praxis Dr. med. Ulf Helwig
      • Saarbrücken, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH
      • Tübingen, Germany, 72076
        • Universitaetsklinik Tuebingen
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II
  • Italy
      • Milano, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Palermo, Italy, 90146
        • Ospedale Villa Sofia-Cervello
      • RHO, Italy
        • Azienda Ospedaliera G.Salvini Ospedale di Rho
      • Roma, Italy, 168
        • Fondazione Policlinico Gemelli Università Cattolica
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10128
        • AO Ordine Mauriziano
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Korea, Republic of, 102-1703
        • KyungHee University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Rotterdam, Netherlands, 3045 PM
        • Sint Franciscus Gasthuis
  • Russian Federation
      • Irkutsk, Russian Federation, 664079
        • Irkutsk State Medical Academy of Postgraduate Education
      • Moscow, Russian Federation, 105554
        • Olla-Med, Llc
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital #31
      • Ufa, Russian Federation, 450005
        • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
  • Spain
      • Alcorcón, Spain, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Ferrol, Spain, 15405
        • Hosp. Arquitecto Marcide
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spain, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Murcia, Spain, 30120
        • Hosp. Univ. Virgen de La Arrixaca
      • Málaga, Spain, 29010
        • Hosp Virgen de La Victoria
      • Pamplona, Spain, 31008
        • Hosp. de Navarra
      • Pontevedra, Spain, 36071
        • Hosp. Montecelo
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Valencia, Spain, 46010
        • Hosp. Clinico Univ. de Valencia
      • Vigo, Spain, 36213
        • Hosp. Alvaro Cunqueiro
      • Zaragoza, Spain, 50009
        • Hosp. Clinico Univ. Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hosp. Univ. Miguel Servet
  • Sweden
      • Malmö, Sweden, 20502
        • Gastromottagningen
      • Stockholm, Sweden, 18288
        • Gastromottagningen
  • United Kingdom
      • Bury, United Kingdom, BL9 7TD
        • Pennine Acute Hospitals-Fairfield General Hospital
      • Cheltenham, United Kingdom, GL53 7AN
        • Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, SW17 OQT
        • St George's Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospitals NHS Trust
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
    • Florida
      • Gainesville, Florida, United States, 32605
        • Florida Research Network, LLC
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Orlando, Florida, United States, 32803
        • Advent Health
      • Tampa, Florida, United States, 33613
        • Florida Hospital Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30342-5020
        • Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialists
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • Ohio State University Hospital
      • Westlake, Ohio, United States, 44145
        • NorthShore Gastroenterology Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Oklahoma Digestive Disease Specialists
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Texas Digestive Disease Consultants
      • Houston, Texas, United States, 77025
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030-2740
        • Houston Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of America, LLC
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 (fCal) >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 ustekinumab intravenous re-induction after the initial weight-tiered-based IV induction dose of ustekinumab
  • Any known history of shortened frequency of SC dose administration (<q8w) for a secondary loss of response where the participant did not, in the opinion of the treating physician, benefit from the dose interval shortening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Ustekinumab approximately 6 mg/kg (IV)
Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
Other Names:
  • STELARA
Drug: Placebo (SC)
Participants will receive SC injection 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.
Other Names:
  • STELARA
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.
Drug: Placebo (IV)
Participants will receive IV infusion of placebo at Week 0.
Drug: Ustekinumab 90 mg (SC) Group 2
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
Other Names:
  • STELARA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Response at Week 16
Time Frame: Week 16
Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From baseline (Week 0) up to Week 36
An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.
From baseline (Week 0) up to Week 36
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: From baseline (Week 0) up to Week 36
A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
From baseline (Week 0) up to Week 36
Percentage of Participants With Treatment-emergent Infections
Time Frame: From baseline (Week 0) up to Week 36
Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
From baseline (Week 0) up to Week 36
Percentage of Participants With Treatment-emergent Serious Infections
Time Frame: From baseline (Week 0) up to Week 36
Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
From baseline (Week 0) up to Week 36
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
Time Frame: Baseline, Weeks 8, 16, 24
Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
Baseline, Weeks 8, 16, 24
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
Time Frame: Baseline, Weeks 8, 16, 24
Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
Baseline, Weeks 8, 16, 24
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
Time Frame: Baseline, Weeks 8, 16, 24
Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
Baseline, Weeks 8, 16, 24
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
Time Frame: Baseline, Weeks 8, 16, 24
Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
Baseline, Weeks 8, 16, 24
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
Time Frame: Baseline, Weeks 8, 16, 24
Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
Baseline, Weeks 8, 16, 24
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
Time Frame: Baseline, Weeks 8, 16, 24
Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.
Baseline, Weeks 8, 16, 24
Percentage of Participants With Clinical Remission at Week 16
Time Frame: Week 16
Percentage of participants with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Week 16
Percentage of Participants With Clinical Response at Week 8
Time Frame: Week 8
Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Week 8
Percentage of Participants With Clinical Remission at Week 8
Time Frame: Week 8
Percentage of participants with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Week 8
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16
Time Frame: Week 16
Percentage of participants with normalization at Week 16, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
Week 16
Percentage of Participants With Clinical Remission at Week 24
Time Frame: Week 24
Percentage of participants with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Week 24
Percentage of Participants With Clinical Response at Week 24
Time Frame: Week 24
Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Week 24
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24
Time Frame: Week 24
Percentage of participants with normalization at Week 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108533
  • 2018-002629-51 (EudraCT Number)
  • CNTO1275CRD3008 (Other Identifier: Janssen-Cilag Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings