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Colitis, UlcerativePhase 2NCT01959282

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

A Phase 2 study testing JNJ-54781532 25 mg once daily, JNJ-54781532 75 mg once daily and JNJ-54781532 150 mg once daily in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 97 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Ulcerative
What is being tested?
JNJ-54781532 25 mg once daily, JNJ-54781532 75 mg once daily and JNJ-54781532 150 mg once daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
219 participants
Where
97 sitesin 14 countries
Study dates
15 Nov 2013to 5 Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

97 sites in 14 countries.

97 sites in 14 countries

United States15 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Chesapeake, Virginia

  • Study site

    Cleveland, Ohio

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Fairfax, Virginia

  • Study site

    Germantown, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Lima, Ohio

  • Study site

    Nashville, Tennessee

  • Study site

    Norman, Oklahoma

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Seattle, Washington

  • Study site

    Thornton, Colorado

  • Study site

    Tupelo, Mississippi

Other trials in United States

Germany12 sites

  • Study site

    Berlin

  • Study site

    Essen

  • Study site

    Frankfurt A. M.

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Herne

  • Study site

    Jena

  • Study site

    Kiel

  • Study site

    Magdeburg

  • Study site

    Münster

  • Study site

    Neustadt

  • Study site

    Stade

Other trials in Germany

Ukraine12 sites

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

  • Study site

    Zhaporozhia 69104

Other trials in Ukraine

Russia10 sites

  • Study site

    Kazan’

  • Study site

    Nizny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Stavropol

  • Study site

    Ufa

  • Study site

    Yaroslavl

Other trials in Russia

Australia8 sites

  • Study site

    Bankstown

  • Study site

    Bedford

  • Study site

    Concord

  • Study site

    Herston

  • Study site

    Launceston

  • Study site

    Melbourne

  • Study site

    Penrith

  • Study site

    South Brisbane

Other trials in Australia

Canada8 sites

  • Study site

    Calgary, Alberta

  • Study site

    Greater Sudbury, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Israel6 sites

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Nazareth

  • Study site

    Ramat Gan

  • Study site

    Rehovot

Other trials in Israel

Belgium4 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Kortrijk

  • Study site

    Leuven

Other trials in Belgium

Hungary4 sites

  • Study site

    Békéscsaba

  • Study site

    Budapest

  • Study site

    Mosonmagyaróvár

  • Study site

    Szekszárd

Other trials in Hungary

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Maastricht

  • Study site

    Rotterdam

Other trials in Netherlands

Poland4 sites

  • Study site

    Elblag

  • Study site

    Lodz

  • Study site

    Sopot

  • Study site

    Warsaw

Other trials in Poland

Romania4 sites

  • Study site

    Bucharest

  • Study site

    Constanța

  • Study site

    Iași

  • Study site

    Timișoara

Other trials in Romania

Bulgaria3 sites

  • Study site

    Pleven

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

France3 sites

  • Study site

    Lille

  • Study site

    Paris

  • Study site

    Pessac

Other trials in France

About this study

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

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

Read the 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).

Being tested
Placebo, JNJ-54781532 25 mg once daily, JNJ-54781532 75 mg once daily, JNJ-54781532 150 mg once daily, JNJ-54781532 75 mg twice daily
Keywords
Colitis, Ulcerative, JNJ-54781532, Moderate, Severe, Active
Medical subject headings
Colitis, Ulcerative, Lymphoma, Follicular, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Participants will receive placebo once daily

  • JNJ-54781532 25 mg once dailyDrug

    Also called ASP015K

    Participants will receive 25 mg of JNJ-54781532 once daily

  • JNJ-54781532 75 mg once dailyDrug

    Also called ASP015K

    Participants will receive 75 mg of JNJ-54781532 once daily

  • JNJ-54781532 150 mg once dailyDrug

    Also called ASP015K

    Participants will receive 150 mg of JNJ-54781532 once daily

  • JNJ-54781532 75 mg twice dailyDrug

    Also called ASP015K

    Participants will receive 75 mg of JNJ-54781532 twice daily

Study groups in NCT01959282
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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
Receives: Drug: Placebo; Drug: JNJ-54781532 150 mg once daily
JNJ-54781532 25 mg once dailyExperimentalParticipants 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
Receives: Drug: JNJ-54781532 25 mg once daily
JNJ-54781532 75 mg once dailyExperimentalParticipants 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
Receives: Drug: JNJ-54781532 75 mg once daily
JNJ-54781532 150 mg once dailyExperimentalParticipants 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
Receives: Drug: JNJ-54781532 150 mg once daily
JNJ-54781532 75 mg twice dailyExperimentalParticipants 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
Receives: Drug: JNJ-54781532 75 mg twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Mayo score at 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.

    Measured: Week 8

Secondary outcomes (3)

  1. Number of participants with clinical response at 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.

    Measured: Week 8

  2. Number of participants with clinical remission at Week 8

    Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.

    Measured: Week 8

  3. Number of participants with mucosal healing at 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.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study start15 Nov 2013
  3. Primary completion20 May 2015
  4. Study completion5 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959282
Sponsor's protocol ID
CR102640
Other IDs
54781532UCO2001, 2013-000263-88
Status last verified
Jan 2019
First submitted
7 Oct 2013
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • 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.

    PubMed 30721964

  • 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.

    PubMed 29917064

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-54781532 25 mg once daily, JNJ-54781532 75 mg once daily and JNJ-54781532 150 mg once daily in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 97 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Germany, Ukraine, Russia, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Mayo score at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959282, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

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