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

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2013-000263-88-DE
• Date of registration: 14/10/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).
• Scientific 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
• Date of first enrolment: 07/01/2014
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000263-88
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Canada, France, Germany, Hungary, Netherlands, Poland, Romania, Russian Federation, Ukraine, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion 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 subscore 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 209
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

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 disseminated herpes zoster
- Previous treatment with a janus kinase inhibitor (eg, tofacitinib)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative Colitis
MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: JNJ-54781532-AAD-5 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Assigned
Current Sponsor code: JNJ-54781532-AAD
Other descriptive name: ASP015K
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: JNJ-54781532-AAD-10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Assigned
Current Sponsor code: JNJ-54781532-AAD
Other descriptive name: ASP015K
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: JNJ-54781532-AAD-30 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Assigned
Current Sponsor code: JNJ-54781532-AAD
Other descriptive name: ASP015K
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: 1. To evaluate the dose response of JNJ-54781532 at Week 8 in subjects with moderately to severely active UC.
2. To evaluate the safety of JNJ-54781532 in subjects with moderately to severely active UC.

Primary end point(s): Change from baseline in the Mayo score at Week 8

Secondary Objective: 1. To evaluate the efficacy of JNJ-54781532 in inducing clinical response at Week 8.
2. To evaluate the efficacy of JNJ-54781532 in inducing clinical remission at Week 8.
3. To evaluate the efficacy of JNJ-54781532 in inducing mucosal healing at Week 8.

Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome(s)

Secondary end point(s): -Clinical response at Week 8
-Clinical remission at Week 8
-Mucosal healing at Week 8

Timepoint(s) of evaluation of this end point: 8 weeks

Secondary ID(s)

54781532UCO2001

Source(s) of Monetary Support

Janssen Research & Development, LLC