A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2016-003633-26-HU
• Date of registration: 08/11/2016
• Prospective Registration: Yes
• Primary sponsor: Lycera Corp.
• Public title: A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS
• Scientific title: A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS
• Date of first enrolment: 23/12/2016
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003633-26
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Czech Republic, Hungary, Netherlands, Poland, Serbia, United States

Contacts

• Name: Lycera Clinical Department
• Affiliation: Lycera Corp.

• Name: Lycera Clinical Department
• Affiliation: Lycera Corp.

Key inclusion & exclusion criteria

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 contraceptive, 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.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.


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

Health Condition(s) or Problem(s) studied

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

Ulcerative Colitis
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Code: LYC-30937-EC
Pharmaceutical Form: Capsule
INN or Proposed INN: LYC-30937
CAS Number: 1796641-10-5
Current Sponsor code: LYC-30937
Other descriptive name: LYC-30937
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Main Objective: The primary objective will be to assess the safety and tolerability of LYC-30937-EC in subjects with Ulcerative Colitis.

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.

Secondary Objective: An exploratory objective will assess symptoms of UC for up to 44 weeks.

Timepoint(s) of evaluation of this end point: After 44 weeks of treatment (and 2 weeks of follow up).

Secondary Outcome(s)

Secondary end point(s): • The change in Mayo stool frequency subscore at Week 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 Week 4, 8, 20, 32 and 44 as compared to the study LYC-30937-2001 Week 8 rectal bleeding subscore

Timepoint(s) of evaluation of this end point: Visit 9/Week 46

Secondary ID(s)

2016-003633-26-NL

NCT02764229

LYC-30937-2002

Source(s) of Monetary Support

Lycera Corp.