Trial record 3 of 191 for:    Open Studies | "Colitis, Ulcerative"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01959282
First received: October 7, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Colitis, Ulcerative
Drug: Placebo
Drug: JNJ-54781532 25 mg once daily
Drug: JNJ-54781532 75 mg once daily
Drug: JNJ-54781532 150 mg once daily
Drug: JNJ-54781532 75 mg twice daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Change from baseline in the Mayo score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of participants with clinical response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Number of participants with clinical remission at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.

  • Number of participants with mucosal healing at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Mucosal healing is an improvement in the endoscopic appearance of the mucosa. An endoscopy subscore of the Mayo score of 0 or 1.


Estimated Enrollment: 220
Study Start Date: November 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: 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 Name: 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 Name: 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 Name: ASP015K

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959282

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 145 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01959282     History of Changes
Other Study ID Numbers: CR102640, 54781532UCO2001, 2013-000263-88
Study First Received: October 7, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Germany: Ethics Commission
Canada: Health Canada

Keywords provided by Janssen Research & Development, LLC:
Colitis, Ulcerative
JNJ-54781532
Moderate
Severe
Active

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014