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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000649-38 | EudraCT Number | ||
| 67864238PACRD2001 | Other Identifier | Janssen Research & Development, LLC | |
| PLATFORMPACRD2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-003335-37 | EudraCT Number |
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IAC completed review of futility analysis data & determined that futility criteria were met. As a result, Janssen made decision to stop trial immediately.
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The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-67864238 | Experimental | Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive oral tablets of matching placebo twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-67864238 | Drug | Participants will receive oral tablets of JNJ-67864238 twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | CDAI is a validated measure of illness severity derived as 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)/opiates, and general well-being). Last 3 variables were scored over 7 days by participant on diary card. Score ranges from 0 to 600; higher score=higher disease activities. Participants who had incomplete data (less than or equal to [<=]4 component values missing) at the visit, had their last available component value carried forward to calculate CDAI Score. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy or adverse event of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to corona virus disease-19 related reasons had their CDAI data as missing. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score= 0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score ranges=0 to 56, where higher scores=more severe disease. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy/AE of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to COVID-19 related reasons had their CDAI data as missing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80920 | United States | ||
| Gastro Florida |
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 Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks. |
| FG001 | JNJ-67864238 | Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2021 | Nov 11, 2022 |
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| Placebo |
| Drug |
Participants will receive oral tablets of matching placebo twice daily. |
|
| Baseline and Week 12 |
| Percentage of Participants With Clinical Response at Week 12 | Percentage of participants with clinical response at Week 12 were reported. Clinical response is defined as a greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score less than (<) 150. 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 3 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. | Week 12 |
| Percentage of Participants With Clinical Remission at Week 12 | Percentage of participants with clinical remission at Week 12 were reported. Clinical remission is defined as CDAI score <150. 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 3 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. | Week 12 |
| Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12 | Percentage of participants with PRO-2 remission at Week 12 were reported. PRO-2 remission is defined as abdominal pain (AP) mean daily score (AP component of the CDAI) <=1 and stool frequency (SF) mean daily score of <=3, that is, AP <=1 and SF <=3. PRO-2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. | Week 12 |
| Percentage of Participants With Endoscopic Response at Week 12 | Endoscopic response is defined as at least 50 percent (%) improvement from baseline in SES-CD score. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease. | Week 12 |
| Percentage of Participants With Endoscopic Remission at Week 12 | Endoscopic remission defined as an SES-CD score of <=2. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease. | Week 12 |
| Clearwater |
| Florida |
| 33756 |
| United States |
| Gastroenterology Associates of Central GA | Macon | Georgia | 31201 | United States |
| CroNOLA, LLC | Houma | Louisiana | 70360 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| NYU Langone Long Island Clinical Research Associates | Lake Success | New York | 11042 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Northshore Gastroenterology Research, LLC | Beachwood | Ohio | 44122 | United States |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | United States |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | United States |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Gastroenterology Research of San Antonio | San Antonio | Texas | 78229 | United States |
| Cer Instituto Medico | Buenos Aires | 1878 | Argentina |
| CINME Centro de Investigaciones Metabolicas | CABA | C1027AAP | Argentina |
| Clinica Adventista Belgrano | Ciudad de Buenos Aires | C1430EGF | Argentina |
| Sanatorio Duarte Quiroz | Córdoba | X5002AOQ | Argentina |
| Centro de Investigaciones Medicas Mar Del Plata | Mar del Plata | B7600FYK | Argentina |
| Fundacion de Estudios Clinicos | Rosario | 2000 | Argentina |
| Universitatsklinikum Schleswig Holstein Kiel | Kiel | 24105 | Germany |
| Eugastro GmbH | Leipzig | 04103 | Germany |
| Universitaetsklinikum Mannheim | Mannheim | 68167 | Germany |
| Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II | Ulm | 89081 | Germany |
| Policlinico di Bari Ospedale Giovanni XXIII | Bari | Italy |
| Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera G. Brotzu | Cagliari | 09134 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Ospedale Policlinico San Martino IRCCS | Genova | 16132 | Italy |
| Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar | Negrar ( Ve) | 37024 | Italy |
| Ospedale Maggiore della Carita | Novara | 28100 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| IRCCS Policlinico San Matteo, Università degli studi di Pavi | Pavia | 27100 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56124 | Italy |
| Azienda Ospedaliera G.Salvini Ospedale di Rho | Rho | Italy |
| Policinico A Gemelli | Roma | 00168 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| A.O.Citta della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok | 15-322 | Poland |
| Endoskopia Sp z o.o. | Sopot | 81-756 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| Centralny Szpital Kliniczny Mswia | Warsaw | 02 507 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 04 141 | Poland |
| Immanuel Kant Baltic Federal University | Kaliningrad | 236016 | Russia |
| Kemerovo Region Clinical Hospital | Kemerovo | 650066 | Russia |
| City Hospital #13 of Avtozavodsky | Nizhny Novgorod | 603018 | Russia |
| Medical Center SibNovoMed LLC | Novosibirsk | 630005 | Russia |
| Rostov State Medical University (RSMU) based on City Hospital No. 20 | Rostov-on-Don | 344091 | Russia |
| International Medical Centre SOGAZ | Saint Petersburg | 191186 | Russia |
| City Hospital named after St. Martyr Elizabeth | Saint Petersburg | 195257 | Russia |
| Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways' | Samara | 443029 | Russia |
| GBUZ Respublican Clinical Hospital n.a. GG Kuvatova | Ufa | 450005 | Russia |
| Medical diagnostic centre LTD 'MDC' | Yaroslavl | 150062 | Russia |
| Medical Center Meditsinskie Tekhnologii | Yekaterinburg | 620075 | Russia |
| MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council | Kharkiv | 61037 | Ukraine |
| GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine | Kharkiv | 61039 | Ukraine |
| Kyivska miska klinichna likarnia 18 | Kyiv | 01030 | Ukraine |
| Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC | Kyiv | 02000 | Ukraine |
| Danylo Halytsky Lviv National Medical University | Lviv | 79010 | Ukraine |
| Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council | Odesa | 65025 | Ukraine |
| Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council | Ternopil | 46002 | Ukraine |
| MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council | Uzhhorod | 88000 | Ukraine |
| Medical Center Ltd 'Health Clinic' | Vinnytsia | 21009 | Ukraine |
| VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council | Vinnytsia | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks. |
| BG001 | JNJ-67864238 | Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | CDAI is a validated measure of illness severity derived as 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)/opiates, and general well-being). Last 3 variables were scored over 7 days by participant on diary card. Score ranges from 0 to 600; higher score=higher disease activities. Participants who had incomplete data (less than or equal to [<=]4 component values missing) at the visit, had their last available component value carried forward to calculate CDAI Score. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy or adverse event of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to corona virus disease-19 related reasons had their CDAI data as missing. | Full analysis set (FAS) included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure (OM). | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score= 0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score ranges=0 to 56, where higher scores=more severe disease. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy/AE of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to COVID-19 related reasons had their CDAI data as missing. | FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
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| Secondary | Percentage of Participants With Clinical Response at Week 12 | Percentage of participants with clinical response at Week 12 were reported. Clinical response is defined as a greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score less than (<) 150. 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 3 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. | FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, were not considered to be in clinical response. | Posted | Number | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Remission at Week 12 | Percentage of participants with clinical remission at Week 12 were reported. Clinical remission is defined as CDAI score <150. 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 3 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. | FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, were not considered to be in clinical remission. | Posted | Number | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12 | Percentage of participants with PRO-2 remission at Week 12 were reported. PRO-2 remission is defined as abdominal pain (AP) mean daily score (AP component of the CDAI) <=1 and stool frequency (SF) mean daily score of <=3, that is, AP <=1 and SF <=3. PRO-2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. | FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, are not considered to be PRO-2 remission. | Posted | Number | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Response at Week 12 | Endoscopic response is defined as at least 50 percent (%) improvement from baseline in SES-CD score. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease. | FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, are not considered to be in endoscopic response. | Posted | Number | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Remission at Week 12 | Endoscopic remission defined as an SES-CD score of <=2. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing [strictures/ stenosis clinically] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease. | FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, are not considered to be in endoscopic remission. | Posted | Number | percentage of participants | Week 12 |
|
Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks. | 0 | 18 | 1 | 18 | 9 | 18 |
| EG001 | JNJ-67864238 | Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks. | 0 | 30 | 4 | 30 | 14 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Basophilia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastritis Haemorrhagic | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Mouth Swelling | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oral Disorder | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatic Cyst | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoferritinaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemangioma of Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dizziness Exertional | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pharyngeal Swelling | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2021 | Nov 11, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ITALY |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| UKRAINE |
|
| UNITED STATES |
|
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks. |
|
|
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|