E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective will be to assess the safety and tolerability of LYC-30937-EC in subjects with Ulcerative Colitis. |
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E.2.2 | Secondary objectives of the trial |
An exploratory objective will assess symptoms of UC for up to 44 weeks. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Completed the 8-week double-blind treatment period of study LYC-30937-2001.
2. Males and females of childbearing potential must agree to use adequate birth control measures during the study. Female subjects of child bearing potential must use 2 highly effective forms of contraception, unless surgically sterilized, partner has had a vasectomy, or they will be abstinent during study participation and for 30 days after their last dose of study drug. Highly effective methods of birth control in this study include: intrauterine device, hormonal contraceptives, (oral, patch, long acting injectable, implant), double-barrier method (condom or diaphragm with spermicide).
3. Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study.
4. Investigator considers it safe and potentially beneficial to participate.
5. Ability to provide written informed consent and to be compliant with the schedule of events. |
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E.4 | Principal exclusion criteria |
1. Subjects who completed LYC-30937-2001, but who experienced a serious adverse event that was considered related to investigational product (IP), or have an unstable medical condition, or for any other reason, in the opinion of the investigator, should not participate in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The incidence and type of AEs, SAEs, and AEs that led to discontinuation of treatment, laboratory assessments, vital sign measurements, ECGs, and PEs. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 44 weeks of treatment (and 2 weeks follow up). |
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E.5.2 | Secondary end point(s) |
• The change in Mayo stool frequency subscore at Weeks 4, 8, 20, 32 and 44 as compared to the study LYC-30937-2001 Week 8 stool frequency subscore
• The change in Mayo rectal bleeding subscore at Weeks 4, 8, 20, 32 and 44 as compared to the study LYC-30937-2001 Week 8 rectal bleeding subscore |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Czech Republic |
Hungary |
Netherlands |
Poland |
Serbia |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 9 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |