A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study

• Register: EUCTR
• Last refreshed on: 13 November 2017
• Main ID: EUCTR2014-002557-19-PL
• Date of registration: 21/01/2015
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)
• Public title: A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study
• Scientific title: A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study
• Date of first enrolment: 30/03/2015
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002557-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Slovakia, Ukraine

Contacts

• Name: General Information
• Affiliation: Mitsubishi Tanabe Pharma Europe Ltd (MTPE)

• Name: General Information
• Affiliation: Mitsubishi Tanabe Pharma Europe Ltd (MTPE)

Key inclusion & exclusion criteria

Inclusion criteria:
1. The subject completed the 14 week Treatment Period in the double-blind MT-1303-E13 study as per Protocol.
2. The subject is able to provide written informed consent and to comply with the requirements of the MT-1303-E14 Protocol during the study.
3. For subjects of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.

For detailed information, please refer to the Protocol.
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 79
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:
1. Permanent discontinuation of study medication prior to the EOT Visit in MT-1303-E13
2. Newly diagnosed diabetes mellitus during the double blind MT-1303-E13 study.

For detailed information, please refer to the Protocol.


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

Health Condition(s) or Problem(s) studied

Subjects with moderate to severe crohn's disease
MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-

Primary Outcome(s)

Primary end point(s): Safety, assessed by:
- Adverse events (AEs)
- Vital signs (pulse rate, blood pressure [BP] and body temperature)
- 12-lead ECG
- Holter ECG monitoring
- Routine safety laboratory assessments
- Physical examination (including skin assessment)
- OCT

Timepoint(s) of evaluation of this end point: Various time points throughout the study - please refer to the detailed ‘Time and Events Schedule’ table in the protocol for full details.

Main Objective: To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active CD

Secondary Objective: • To evaluate the long-term effects of MT-1303 on clinical outcomes in subjects with moderate to severe active CD
• To explore the pharmacodynamic (PD) effects of MT-1303 in subjects with moderate to severe active CD.

Secondary Outcome(s)

Secondary end point(s): Efficacy
• Proportion of subjects who achieve a 70 point decrease from MT-1303-E13 baseline in Crohn’s disease activity index (CDAI) score (i.e., CDAI 70) at Protocol-scheduled visits
• Proportion of subjects who achieve a 100-point decrease from MT-1303-E13 baseline in CDAI score (i.e., CDAI 100) at Protocol-scheduled visits
• Proportion of subjects who achieve clinical remission (i.e., CDAI score of <150) at Protocol-scheduled visits
• CDAI score and change from MT-1303-E13 baseline in CDAI score at Protocol scheduled visits
• Proportion of subjects in corticosteroid-free remission at end of treatment (EOT)

Pharmacodynamics
• Lymphocyte counts and lymphocyte subsets, their change from MT-1303-E13 baseline and percentage of MT-1303-E13 baseline at Protocol-scheduled visits
• C-reactive protein (CRP) and faecal calprotectin value and their change from MT-1303-E13 baseline at Protocol-scheduled visits.

Timepoint(s) of evaluation of this end point: Various time points throughout the study - please refer to the detailed ‘Time and Events Schedule’ table in the protocol for full details.

Secondary ID(s)

2014-002557-19-CZ

MT-1303-E14

Source(s) of Monetary Support

Mitsubishi Tanabe Pharma Corporation (MTPC)