Clinical trial NCT01959282: A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Keywords: Colitis, Ulcerative
JNJ-54781532
Moderate
Severe
Active
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 219
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 evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Detailed description: This is a Phase 2b, multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), parallel-group (each group of participants will be treated at the same time), dose-response study (a study to evaluate response to different dosages of study medication) of oral tablets of JNJ-54781532 in adult participants with moderately to severely active UC. Approximately 220 participants will be randomized in a 1:1:1:1:1 ratio to 1 of 5 treatment groups at Week 0 (placebo; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 150 mg once daily; and JNJ-54781532 75 mg twice daily) to receive their randomized dosage of study medication through Week 8 and will be assessed for clinical response at Week 8. Participants who achieve clinical response at Week 8 will continue to receive their original randomized dosage of study medication through Week 32. Participants who do not achieve clinical response at Week 8 will be treated as follows: participants originally randomized to placebo will receive JNJ-54781532 150 mg once daily through Week 16; participants originally randomized to JNJ-54781532 will continue to receive their original randomized dosage of JNJ-54781532 through Week 16. Participants who were not in clinical response at Week 8 and do not achieve a partial Mayo score response (a decrease from baseline in the partial Mayo score by ≥3 points) at Week 16 will be discontinued from study medication; and those who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 through Week 32. Participants will be evaluated for safety (adverse events) up to Week 36 (ie, 4 weeks after the last dose of study medication). The maximum study duration for each participant will be approximately 44 weeks (including maximum screening period).

Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of ulcerative colitis (UC) at least 3 months prior to screening
* Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12; including an endoscopy sub score greater than or equal to 2 as determined by a central read of the video endoscopy
* Current treatment with oral corticosteroids or have a history of failure to respond to, or tolerate, at least 1 of the following therapies oral corticosteroids (including budesonide), 6-mercaptopurine (6-MP), azathioprine (AZA), or anti- tumor necrosis factor therapy or be corticosteroid dependent (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
* Must discontinue 6-MP/AZA for at least 1 week before the first dose of study medication

Exclusion Criteria:

* At imminent risk for colectomy
* Have ulcerative colitis limited to the rectum only or to less than 20 centimeter of the colon
* Presence of a stoma
* Presence or history of a fistula
* History or current diagnosis of active or latent tuberculosis; human immunodeficiency virus; hepatitis C virus or hepatitis B virus infection; have had more than 1 herpes zoster infection or have had any diagnosis of disseminated herpes zoster
* Previous treatment with a janus kinase inhibitor (eg, tofacitinib)

Primary outcomes:
measure: Change from baseline in the Mayo score at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Number of participants with clinical response at Week 8
timeFrame: Week 8
measure: Number of participants with clinical remission at Week 8
timeFrame: Week 8
measure: Number of participants with mucosal healing at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Thornton
country: United States
state: Colorado
city: Ann Arbor
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Egg Harbor Township
country: United States
state: New Jersey
city: Salisbury
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Bankstown
country: Australia
city: Bedford
country: Australia
city: Concord
country: Australia
city: Herston
country: Australia
city: Launceston
country: Australia
city: Melbourne
country: Australia
city: Penrith
country: Australia
city: South Brisbane
country: Australia
city: Brussel
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Lille Cedex
country: France
city: Paris
country: France
city: Pessac
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Frankfurt A. M.
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Magdeburg
country: Germany
city: Münster
country: Germany
city: Neustadt
country: Germany
city: Stade
country: Germany
city: Budapest N/A
country: Hungary
city: Budapest
country: Hungary
city: Békéscsaba
country: Hungary
city: Mosonmagyarovar
country: Hungary
city: Szekszárd
country: Hungary
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Nazareth
country: Israel
city: Ramat Gan
country: Israel
city: Rechovot
country: Israel
city: Amsterdam Zuidoost
country: Netherlands
city: Amsterdam
country: Netherlands
city: Maastricht
country: Netherlands
city: Rotterdam
country: Netherlands
city: Elblag
country: Poland
city: Lodz
country: Poland
city: Sopot
country: Poland
city: Warszawa
country: Poland
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Kazan N/A
country: Russian Federation
city: Nizny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Rostov-On-Don
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ufa
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Donetsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zhaporozhia 69104
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.
citation: Sands BE, Sandborn WJ, Feagan BG, Lichtenstein GR, Zhang H, Strauss R, Szapary P, Johanns J, Panes J, Vermeire S, O'Brien CD, Yang Z, Bertelsen K, Marano C; Peficitinib-UC Study Group. Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results From a Randomised, Phase 2 Study. J Crohns Colitis. 2018 Nov 9;12(10):1158-1169. doi: 10.1093/ecco-jcc/jjy085.