TUC3PII-01_TU2670 Phase IIa Clinical Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    80
  • sponsor
    TiumBio Co., Ltd.
Updated on 10 December 2021
endometriosis

Summary

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.

Description

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.

Details
Condition Endometriosis, Female Genital Diseases, Gynecological Infections
Treatment Placebo Comparator: Placebo, Active Comparator: TU2670 320mg, Active Comparator: TU2670 240mg, Active Comparator: TU2670 120mg
Clinical Study IdentifierNCT05138562
SponsorTiumBio Co., Ltd.
Last Modified on10 December 2021

Eligibility

Yes No Not Sure

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
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