TUC3PII-01_TU2670 Phase IIa Clinical Study

NCT ID: NCT05138562

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2024-08-05

Brief 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.

Detailed 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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

4 Placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Placebo

Intervention Type: DRUG

4 x placebo capsules, QD

TU2670 High Dose

320mg, QD

Group Type: ACTIVE_COMPARATOR

Active Comparator: TU2670 320mg

Intervention Type: DRUG

320mg (80mg x 4), QD

TU2670 Medium Dose

240 mg, QD

Group Type: ACTIVE_COMPARATOR

Active Comparator: TU2670 240mg

Intervention Type: DRUG

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

TU2670 Low Dose

120 mg, QD

Group Type: ACTIVE_COMPARATOR

Active Comparator: TU2670 120mg

Intervention Type: DRUG

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

Interventions

Placebo Comparator: Placebo

4 x placebo capsules, QD

Intervention Type: DRUG

Active Comparator: TU2670 320mg

320mg (80mg x 4), QD

Intervention Type: DRUG

Active Comparator: TU2670 240mg

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

Intervention Type: DRUG

Active Comparator: TU2670 120mg

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TiumBio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Hradec Kralove

Hradec Králové, Hradec Kralove, Czechia

Kestr-gyn s.r.o., Gynekologicka ambulance

Náchod, Nachod, Czechia

Fakultni Nemocnice Kralovske Vinohrady

Prague, Prague, Czechia

OB/GYN

Prague, Praha 1, Czechia

Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK

Prague, Praha 2, Czechia

University Hospital Brno

Brno, , Czechia

NEUMED gynekologicka ambulance

Olomouc, , Czechia

Nemocnice Na Bulovce

Prague, , Czechia

Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula

Monserrato, Cagliari, Italy

Azienda ospedaliero-universitaria Senese

Siena, Tuscany, Italy

University of Florence

Florence, , Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

Milan, , Italy

AZIENDA Ospedaliero Univeritaria Di Modena

Modena, , Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

P.O. Sant'Anna

Torino, , Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

In Vivo sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Dolnośląskie Centrum Ginekologii

Wroclaw, Lower Silesian Voivodeship, Poland

Komed Centra Kliniczne

Lublin, Lublin Voivodeship, Poland

Hospital Pro-Familia

Rzeszów, Podkarpackie Voivodeship, Poland

Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o.

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Mikołowska

Katowice, Silesian Voivodeship, Poland

Examen sp z o.o.

Skorzewo, Wielkopolska, Poland

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

Bialystok, , Poland

Provita Sp. z o.o.

Katowice, , Poland

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic

Poznan, , Poland

Gameta Hospital

Rzeszów, Łódź Voivodeship, Poland

Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry

Yekaterinburg, Sverdlovsk Oblast, Russia

State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department

Moscow, , Russia

FSHI Clinical Hospital #85 of FMBA

Moscow, , Russia

Moscow State University of Medicine and Dentistry

Moscow, , Russia

SBIH Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child

Vinnytsia, Vinnitsia, Ukraine

Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council

Zaporizhzhya, Zaporizhzhia Oblast, Ukraine

State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine

Kiev, , Ukraine

Kyiv city clinical hospital #9, Department of gynecology

Kyiv, , Ukraine

Lviv city clinical hospital #4

Lviv, , Ukraine

Danylo Halytskyy Lviv national medical university

Lviv, , Ukraine

Private Small-Scale Enterprise Medical Centre Pulse

Vinnytsia, , Ukraine

Countries

Czechia; Italy; Poland; Russia; Ukraine

Other Identifiers

TUC3PII-01

Identifier Type: -

Identifier Source: org_study_id