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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002557-19-CZ

Enrollment

Registered

2014-09-30

Start date

2014-11-27

Completion date

Unknown

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The subject completed the 14 week Treatment Period in the doubleblind 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

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.

Design outcomes

Primary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

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

Contacts

Public ContactGeneral Information

Mitsubishi Tanabe Pharma Europe Ltd (MTPE)

regulatory@mt-pharma-eu.com0044(0)2070655000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026