A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

January 3, 2019 updated by: Janssen Research & Development, LLC

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

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 2

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

  • Australia
      • Bankstown, Australia
      • Bedford, Australia
      • Concord, Australia
      • Herston, Australia
      • Launceston, Australia
      • Melbourne, Australia
      • Penrith, Australia
      • South Brisbane, Australia
  • Belgium
      • Brussel, Belgium
      • Gent, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
  • Bulgaria
      • Pleven, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • London, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Lille Cedex, France
      • Paris, France
      • Pessac, France
  • Germany
      • Berlin, Germany
      • Essen, Germany
      • Frankfurt A. M., Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Herne, Germany
      • Jena, Germany
      • Kiel, Germany
      • Magdeburg, Germany
      • Münster, Germany
      • Neustadt, Germany
      • Stade, Germany
  • Hungary
      • Budapest, Hungary
      • Budapest N/A, Hungary
      • Békéscsaba, Hungary
      • Mosonmagyarovar, Hungary
      • Szekszárd, Hungary
  • Israel
      • Hadera, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Nazareth, Israel
      • Ramat Gan, Israel
      • Rechovot, Israel
  • Netherlands
      • Amsterdam, Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
  • Poland
      • Elblag, Poland
      • Lodz, Poland
      • Sopot, Poland
      • Warszawa, Poland
  • Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Constanta, Romania
      • Iasi, Romania
      • Timisoara, Romania
  • Russian Federation
      • Kazan N/A, Russian Federation
      • Nizny Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Omsk, Russian Federation
      • Rostov-On-Don, Russian Federation
      • Ryazan, Russian Federation
      • Saint Petersburg, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Ufa, Russian Federation
      • Yaroslavl, Russian Federation
  • Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankovsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Kiiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Ternopil, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsa, Ukraine
      • Zaporizhzhia, Ukraine
      • Zhaporozhia 69104, Ukraine
  • United States
    • California
      • La Jolla, California, United States
    • Colorado
      • Thornton, Colorado, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
    • North Carolina
      • Salisbury, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Lima, Ohio, United States
    • Oklahoma
      • Norman, Oklahoma, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Fairfax, Virginia, United States
    • Washington
      • Seattle, Washington, United States

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive placebo through Week 32. Participants not in clinical response at Week 8 will receive treatment with 150 mg JNJ-54781532 orally once daily from Week 8 to Week 16. Participants who achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) at Week 16 can continue receiving 150 mg JNJ-54781532 orally once daily through Week 32
Drug: Placebo
Participants will receive placebo once daily
Drug: JNJ-54781532 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily
Other Names:
  • ASP015K
Experimental: JNJ-54781532 25 mg once daily
Participants will receive 25 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 25 mg once daily through Week 32
Drug: JNJ-54781532 25 mg once daily
Participants will receive 25 mg of JNJ-54781532 once daily
Other Names:
  • ASP015K
Experimental: JNJ-54781532 75 mg once daily
Participants will receive 75 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 75 mg once daily through Week 32
Drug: JNJ-54781532 75 mg once daily
Participants will receive 75 mg of JNJ-54781532 once daily
Other Names:
  • ASP015K
Experimental: JNJ-54781532 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 150 mg once daily through Week 32
Drug: JNJ-54781532 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily
Other Names:
  • ASP015K
Experimental: JNJ-54781532 75 mg twice daily
Participants will receive 75 mg of JNJ-54781532 twice daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 75 mg twice daily through Week 32
Drug: JNJ-54781532 75 mg twice daily
Participants will receive 75 mg of JNJ-54781532 twice daily
Other Names:
  • ASP015K

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Mayo score at Week 8
Time Frame: Week 8
The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical response at Week 8
Time Frame: Week 8
Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.
Week 8
Number of participants with clinical remission at Week 8
Time Frame: Week 8
Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.
Week 8
Number of participants with mucosal healing at Week 8
Time Frame: Week 8
Mucosal healing is an improvement in the endoscopic appearance of the mucosa. An endoscopy subscore of the Mayo score of 0 or 1.
Week 8

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

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

Helpful Links

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)

November 15, 2013

Primary Completion (Actual)

May 20, 2015

Study Completion (Actual)

December 5, 2015

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR102640
  • 54781532UCO2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2013-000263-88 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

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