Clinical trial NCT02877134: Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Have 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
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[b-hCG\]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
* Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram 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, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
* A participant who has had extensive colitis for greater than or equal to (\>=) 8 years, or disease limited to the left side of the colon for \>= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
* Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of \>= 220 but \<= 450

Exclusion Criteria:

* Participants who have received intravenous (IV) corticosteroids less then (\<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody \[mAb\] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) \<8 weeks or have received Vedolizumab \<16 weeks before the first administration of study drug
* Woman who is pregnant or planning pregnancy or is a man who plans to father while randomized in the study or within 16 weeks after the last administration of study agent
* Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
* Participants with a history of or ongoing chronic or recurrent infectious disease
* Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Primary outcomes:
measure: Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8
timeFrame: Baseline to Week 8
measure: Part II: Change From Baseline in the CDAI Score at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)
timeFrame: Week 12
measure: Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150)
timeFrame: Week 12
measure: Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12
timeFrame: Baseline, Week 12
measure: Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)
timeFrame: Week 12
measure: Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75)
timeFrame: Week 12
measure: Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Lone Tree
country: United States
state: Colorado
city: Coral Gables
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Houma
country: United States
state: Louisiana
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Columbia
country: United States
state: Maryland
city: Morristown
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Doylestown
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Liège
country: Belgium
city: Sofia
country: Bulgaria
city: Brandon
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Amiens
country: France
city: Lille
country: France
city: Marseille
country: France
city: Paris
country: France
city: Pierre-Bénite
country: France
city: Saint-Etienne
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Ludwigshafen
country: Germany
city: Luebeck
country: Germany
city: Lüneburg
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Szekszárd
country: Hungary
city: Szombathely
country: Hungary
city: Asahikawa
country: Japan
city: Chikushino-shi
country: Japan
city: Fukushima
country: Japan
city: Gunma
country: Japan
city: Hamamatsu-Shi
country: Japan
city: Hirosaki
country: Japan
city: Hitachi
country: Japan
city: Hyôgo
country: Japan
city: Isehara
country: Japan
city: Kagoshima
country: Japan
city: Kahoku-gun
country: Japan
city: Kamakura
country: Japan
city: Kanagawa
country: Japan
city: Kanazawa
country: Japan
city: Kashiwa
country: Japan
city: Midori-ku
country: Japan
city: Minato-ku
country: Japan
city: Niigata
country: Japan
city: Okinawa
country: Japan
city: Osaka-Sayama
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Sakura
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Shimotsuga Gun
country: Japan
city: Shimotsuke
country: Japan
city: Shinjuku ku
country: Japan
city: Shinjuku-ku
country: Japan
city: Sunto-gun
country: Japan
city: Bundang
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Guri-si
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon si
country: Korea, Republic of
city: Bydgoszcz
country: Poland
city: Chorzow
country: Poland
city: Krakow
country: Poland
city: Ksawerow
country: Poland
city: Lodz
country: Poland
city: Oswiecim
country: Poland
city: Poznan
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wloclawek
country: Poland
city: Wroclaw
country: Poland
city: Bucuresti
country: Romania
city: Oradea
country: Romania
city: Timisoara
country: Romania
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscov
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: Sankt-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tosno
country: Russian Federation
city: Chernivtsi
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiyv
country: Ukraine
city: Kropyvnytskyi
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Sumy
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zhaporozhia
country: Ukraine
city: Cambridge
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Sutton In Ashfield
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: