Clinical trial NCT04102111: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of greater than or equal to (\>=) 220 and less than or equal to (\<=) 450
* Have evidence of active ileocolonic Crohn's disease as assessed by an Simplified Endoscopic Score for Crohn's disease (SES-CD) score \>=3 at screening by central endoscopy reading; or an elevated screening C-reactive protein (CRP) (greater than \[\>\] 0.3 milligrams per deciliter \[mg/dL\] or 3.0 milligrams per liter \[mg/L\]) or an elevated screening fecal calprotectin (\>250 micrograms per mg \[mcg/mg\])
* A participant with a family history of colorectal cancer, personal history of increased risk of colorectal cancer, age \> 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening). Adenomatous polyps must be removed before the first administration of the study intervention
* A woman of childbearing potential must have a negative highly sensitive serum (Beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
* Has previously demonstrated inadequate response to, loss of response to, or intolerance to an approved biologic therapy (unless otherwise specified in the JNJ-67864238 intervention cohort specific criteria, that is, anti-tumor necrosis factor (TNF) alpha agents (for example, infliximab, adalimumab, certolizumab pegol\], anti- interleukin (IL)-12/23 agents \[for example, ustekinumab\], or anti-integrin agents \[for example, vedolizumab\]) or has previously demonstrated an inadequate response to or failed to tolerate corticosteroids or immunomodulators (that is, 6-mercaptopurine \[6-MP\], azathioprine \[AZA\], and methotrexate \[MTX\]) but not a biologic, that is, the biologic nonfailures (Bio-NF) population
* Therapy for the treatment of Crohn's disease must include at least 1 of the following medications, which should have been maintained at stable doses prior to the baseline (Week 0) visit: (a) Oral 5-aminosalicylic acid (5-ASA) compounds; (b) Oral corticosteroids at a prednisone-equivalent dose \<= 25 milligrams per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate; (c) Antibiotics being used as a primary treatment of Crohn's disease; and (d) Conventional immunomodulators (that is, AZA, 6-MP, or MTX) if participants have been taking them for at least 12 weeks and have been at a stable dose for at least 4 weeks prior to baseline

Exclusion Criteria:

* Prior exposure to an anti-IL-12/23 (that is ustekinumab) or anti-IL-23 agents or related compound (including risankizumab, brazikumab, guselkumab, mirikizumab, and related compounds). Exception is made for participants who have had minimal exposure to ustekinumab at its approved labeled dosage and have met the required wash-out criteria and have not demonstrated inadequate response or intolerance to ustekinumab
* Known allergies, hypersensitivity, or intolerance to JNJ-67864238 or its excipients
* Has 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 JNJ-67864238
* Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
* Initiation of total (complete) or partial (supplemental) parenteral nutrition administered through any indwelling catheter less than (\<) 3 weeks before baseline or anticipated to require parenteral nutrition administered through an indwelling catheter during enrollment in the study

Primary outcomes:
measure: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Clinical Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Clinical Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Endoscopic Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Endoscopic Remission at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central GA
state: Georgia
city: Houma
country: United States
facility: CroNOLA, LLC
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Lake Success
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Beachwood
country: United States
facility: Northshore Gastroenterology Research, LLC
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Westlake
country: United States
facility: Northshore Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: Buenos Aires
country: Argentina
facility: Cer Instituto Medico
city: Caba
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas
city: Ciudad De Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Cordoba
country: Argentina
facility: Sanatorio Duarte Quiroz
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Fundacion de Estudios Clinicos
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II
city: Bari
country: Italy
facility: Policlinico di Bari Ospedale Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Negrar ( Ve)
country: Italy
facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
city: Novara
country: Italy
facility: Ospedale Maggiore della Carita
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: RHO
country: Italy
facility: Azienda Ospedaliera G.Salvini Ospedale di Rho
city: Roma
country: Italy
facility: Policinico A Gemelli
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: A.O.Citta della Salute e della Scienza di Torino
city: Bialystok
country: Poland
facility: Gastromed Kralisz Romatowski Stachurska Sp. j.
city: Sopot
country: Poland
facility: Endoskopia Sp z o.o.
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny Mswia
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Ekaterinburg
country: Russian Federation
facility: Medical Center Meditsinskie Tekhnologii
city: Kaliningrad
country: Russian Federation
facility: Immanuel Kant Baltic Federal University
city: Kemerovo
country: Russian Federation
facility: Kemerovo Region Clinical Hospital
city: Nizhniy Novgorod
country: Russian Federation
facility: City Hospital #13 of Avtozavodsky
city: Novosibirsk
country: Russian Federation
facility: Medical Center SibNovoMed LLC
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University (RSMU) based on City Hospital No. 20
city: Saint-Petersburg
country: Russian Federation
facility: City Hospital named after St. Martyr Elizabeth
city: Samara
country: Russian Federation
facility: Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways'
city: St-Petersburg
country: Russian Federation
facility: International Medical Centre SOGAZ
city: Ufa
country: Russian Federation
facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
city: Yaroslavl
country: Russian Federation
facility: Medical diagnostic centre LTD 'MDC'
city: Kharkiv
country: Ukraine
facility: MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Kyivska miska klinichna likarnia 18
city: Kyiv
country: Ukraine
facility: Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
city: Odesa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Ternopil
country: Ukraine
facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
city: Uzhgorod
country: Ukraine
facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
city: Vinnytsya
country: Ukraine
facility: Medical Center Ltd 'Health Clinic'
city: Vinnytsya
country: Ukraine
facility: VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: