TUC3PII-01_TU2670 Phase IIa Clinical Study

NCT05138562 | Completed Phase 2

• 1 other identifier: TUC3PII-01
• Study Type: interventional
• Target: 86
• Locations: 5 countries
• Sites: 40

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• overall pelvic pain

  Change from baseline to 12 weeks of treatment of the mean dysmenorrhea score (defined as mean overall pelvic pain score on menstrual bleeding days) as measured by the Numeric Rating Scale(minimum 0, maximum 10, higher score mean a worse outcome) over the past month.

  12 weeks

Secondary Outcomes (11)

• mean Numeric Rating Scale pain score

  12 weeks

• mean overall pelvic pain Numeric Rating Scale pain score

  12 weeks

• mean Numeric Rating Scale dyspareunia score

  12 weeks

• rescue medication

  12 weeks

• Time to increase of dose of rescue medication

  12 weeks

Other Outcomes (1)

• Bone mineral density loss

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

4 Placebo capsules

Drug: Placebo Comparator: Placebo

TU2670 High Dose

ACTIVE COMPARATOR

320mg, QD

Drug: Active Comparator: TU2670 320mg

TU2670 Medium Dose

ACTIVE COMPARATOR

240 mg, QD

Drug: Active Comparator: TU2670 240mg

TU2670 Low Dose

ACTIVE COMPARATOR

120 mg, QD

Drug: Active Comparator: TU2670 120mg

Interventions

Placebo Comparator: Placebo DRUG

4 x placebo capsules, QD

Placebo

Active Comparator: TU2670 320mg DRUG

320mg (80mg x 4), QD

TU2670 High Dose

Active Comparator: TU2670 240mg DRUG

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

TU2670 Medium Dose

Active Comparator: TU2670 120mg DRUG

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

TU2670 Low Dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TiumBio Co., Ltd.: lead

Study Sites (40)

University Hospital Hradec Kralove

Hradec Králové, Hradec Kralove, 50005, Czechia

Location

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

Náchod, Nachod, 54701, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady

Prague, Prague, 10034, Czechia

Location

OB/GYN

Prague, Praha 1, 11000, Czechia

Location

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

Prague, Praha 2, 128 08, Czechia

Location

University Hospital Brno

Brno, 62500, Czechia

Location

NEUMED gynekologicka ambulance

Olomouc, 77900, Czechia

Location

Nemocnice Na Bulovce

Prague, 18100, Czechia

Location

Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula

Monserrato, Cagliari, 09042, Italy

Location

Azienda ospedaliero-universitaria Senese

Siena, Tuscany, 53100, Italy

Location

University of Florence

Florence, 50129, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

AZIENDA Ospedaliero Univeritaria Di Modena

Modena, 41124, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

P.O. Sant'Anna

Torino, 10126, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

In Vivo sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85090, Poland

Location

Dolnośląskie Centrum Ginekologii

Wroclaw, Lower Silesian Voivodeship, 53333, Poland

Location

Komed Centra Kliniczne

Lublin, Lublin Voivodeship, 20362, Poland

Location

Hospital Pro-Familia

Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

Location

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

Bialystok, Podlaskie Voivodeship, 15224, Poland

Location

Centrum Medyczne Mikołowska

Katowice, Silesian Voivodeship, 40065, Poland

Location

Examen sp z o.o.

Skorzewo, Wielkopolska, 60185, Poland

Location

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

Bialystok, 15267, Poland

Location

Provita Sp. z o.o.

Katowice, 40611, Poland

Location

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic

Poznan, 60529, Poland

Location

Gameta Hospital

Rzeszów, Łódź Voivodeship, 95030, Poland

Location

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

Yekaterinburg, Sverdlovsk Oblast, 620146, Russia

Location

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

Moscow, 115280, Russia

Location

FSHI Clinical Hospital #85 of FMBA

Moscow, 115409, Russia

Location

Moscow State University of Medicine and Dentistry

Moscow, 127473, Russia

Location

SBIH Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

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, 76018, Ukraine

Location

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

Vinnytsia, Vinnitsia, 21019, Ukraine

Location

Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council

Zaporizhzhya, Zaporizhzhia Oblast, 69065, Ukraine

Location

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

Kiev, 04053, Ukraine

Location

Kyiv city clinical hospital #9, Department of gynecology

Kyiv, 04112, Ukraine

Location

Lviv city clinical hospital #4

Lviv, 79005, Ukraine

Location

Danylo Halytskyy Lviv national medical university

Lviv, 79010, Ukraine

Location

Private Small-Scale Enterprise Medical Centre Pulse

Vinnytsia, 21001, Ukraine

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 1, 2021
• Study Start: August 19, 2021
• Primary Completion: January 23, 2024
• Study Completion: August 5, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

PL (11); CZ (8); UA (8); IT (8); RU (5)