TUC3PII-01_TU2670 Phase IIa Clinical Study

Ведущий спонсор: TiumBio Co., Ltd.

This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.

Treatment Groups and Duration: Following a washout period of up to 12 weeks, subjects will enter a screening period of up to 12 weeks including an observation period consisting of a complete menstrual cycle. Subjects will be randomly assigned in a 1:1:1:1 ratio to receive either 12 weeks of TU2670 320 mg QD, TU2670 240 mg QD, TU2670 120 mg QD, or matching placebo. TU2670 or a matching placebo will be administered in the clinic on Day 1. Subjects in the PK subset population will also receive the following additional doses in the clinic: Day 2 (after collection of the 24-hour PK sample); the dose on the day scheduled for subsequent serial PK sample collection (Week 4 or Week 5); and the next scheduled dose (after collection of the 24-hour PK sample). All other doses can be taken by the subject at home. Following the end of treatment, subjects will be followed up for safety for 12 weeks. Statistical Methods: All formal statistical tests will be done at the 5% 2-sided significance level. Point estimates will have 2 sided 95% confidence intervals (CIs) where applicable. Where appropriate, variables will be summarized descriptively (frequency and percent will be summarized for categorical variables; n (number of available subjects), mean, standard deviation [SD], median, minimum, and maximum will be presented for continuous variables) by study visit and by treatment group. Statistical summaries will be presented for the changes from baseline to each time point in efficacy endpoints that it is applicable.

• Endometriosis

Тип вмешательства: Drug

Название вмешательства: Placebo Comparator: Placebo

Описание: 4 x placebo capsules, QD

Этикетка Arm Group: Placebo

Тип вмешательства: Drug

Название вмешательства: Active Comparator: TU2670 320mg

Описание: 320mg (80mg x 4), QD

Этикетка Arm Group: TU2670 High Dose

Тип вмешательства: Drug

Название вмешательства: Active Comparator: TU2670 240mg

Описание: 240mg (80mg x 3 + placebo x 1), QD

Этикетка Arm Group: TU2670 Medium Dose

Тип вмешательства: Drug

Название вмешательства: Active Comparator: TU2670 120mg

Описание: 120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD

Этикетка Arm Group: TU2670 Low Dose

Критерии:

Inclusion Criteria: - Independent Ethics Committee (IEC)-approved written informed consent/assent and privacy language as per national regulations must be voluntarily obtained from the subject. - Premenopausal female subject, 18 to 45 years, inclusive - Subject has moderate to severe endometriosis-related pain Exclusion Criteria: - Subject has used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks - Subject has been nonresponsive to GnRH-agonist or antagonist therapy for the management of endometriosis.

Пол:

Female

Минимальный возраст:

18 Years

Максимальный возраст:

45 Years

Здоровые волонтеры:

No

Фамилия: Tium Bio

Телефон: +82-31-600-1500

Czechia

Italy

Poland

Russian Federation

Ukraine

2021-11-01

Тип: Sponsor

• Endometriosis

Метка: Placebo

Тип: Placebo Comparator

Описание: 4 Placebo capsules

Метка: TU2670 High Dose

Тип: Active Comparator

Описание: 320mg, QD

Метка: TU2670 Medium Dose

Тип: Active Comparator

Описание: 240 mg, QD

Метка: TU2670 Low Dose

Тип: Active Comparator

Описание: 120 mg, QD

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)