TUC3PII-01_TU2670 Phase IIa Clinical Study

Endometriosis Clinical Trial

Official title:

A Phase IIa, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of Orally Administered TU2670 in Subjects With Mod to Severe Endometriosis-Associated Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138562
• Other study ID #: TUC3PII-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: TiumBio Co., Ltd.
• Contact: Tium Bio
• Phone: +82-31-600-1500
• Email: NCE403_TU2670[@]tiumbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Placebo Comparator: Placebo
4 x placebo capsules, QD
• Active Comparator: TU2670 320mg
320mg (80mg x 4), QD
• Active Comparator: TU2670 240mg
240mg (80mg x 3 + placebo x 1), QD
• Active Comparator: TU2670 120mg
120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno
Czechia	University Hospital Hradec Kralove	Hradec Králové	Hradec Kralove
Czechia	Kestr-gyn s.r.o., Gynekologicka ambulance	Náchod	Nachod
Czechia	NEUMED gynekologicka ambulance	Olomouc
Czechia	Nemocnice Na Bulovce	Prague
Czechia	OB/GYN	Praha	Praha 1
Czechia	Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK	Praha	Praha 2
Czechia	Fakultni Nemocnice Kralovske Vinohrady	Praha 10	Praha
Italy	University of Florence	Florence
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano	Milano
Italy	AZIENDA Ospedaliero Univeritaria Di Modena	Modena
Italy	Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula	Monserrato	Cagliari
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma
Italy	Azienda ospedaliero-universitaria Senese	Siena	Tuscany
Italy	P.O. Sant'Anna	Torino
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Poland	Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian	Bialystok
Poland	Prywatna Klinika Polozniczo-Ginekologiczna Sp. z o.o.	Bialystok	Podlaskie
Poland	In Vivo sp. z o.o.	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Mikolowska	Katowice	Silesia
Poland	Provita Sp. z o.o.	Katowice
Poland	Komed Centra Kliniczne	Lublin	Lubelskie
Poland	Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian, Fertility Clinic	Poznan
Poland	Gameta Hospital	Rzeszów	Lodzkie
Poland	Hospital Pro-Familia	Rzeszów	Podkarpackie
Poland	Examen sp z o.o.	Skorzewo	Wielkopolska
Poland	Dolnoslaskie Centrum Ginekologii	Wroclaw	Dolnoslaskie
Russian Federation	Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry	Ekaterinburg	Sverdlovskaya Oblast
Russian Federation	FSHI Clinical Hospital #85 of FMBA	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow
Russian Federation	State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department	Moscow
Russian Federation	SBIH Leningrad Regional Clinical Hospital	Saint Petersburg
Ukraine	Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council	Ivano-Frankivs'k	Ivano-Frankivsk
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	Danylo Halytskyy Lviv national medical university	Lviv
Ukraine	Lviv city clinical hospital #4	Lviv
Ukraine	Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child	Vinnytsia	Vinnitsia
Ukraine	Private Small-Scale Enterprise Medical Centre Pulse	Vinnytsia
Ukraine	Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council	Zaporizhzhya	Zaporizhzhya Oblast

Sponsors (1)

Lead Sponsor	Collaborator
TiumBio Co., Ltd.

Countries where clinical trial is conducted

Czechia,  Italy,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone mineral density loss	Change from baseline to 12 weeks of treatment of the bone mineral density as assessed by dual-energy X-ray absorptiometry (DXA)	12 weeks
Primary	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	mean Numeric Rating Scale pain score	Change from baseline to 12 weeks of treatment of the mean Numeric Rating Scale pain score(minimum 0, maximum 10, higher score mean a worse outcome) for non-menstrual pelvic pain (mean Numeric Rating Scale pain score on non menstrual bleeding days)	12 weeks
Secondary	mean overall pelvic pain Numeric Rating Scale pain score	Change from baseline to 12 weeks of treatment of the mean overall pelvic pain Numeric Rating Scale pain score (mean Numeric Rating Scale pain score(minimum 0, maximum 10, higher score mean a worse outcome) over all 28 days)	12 weeks
Secondary	mean Numeric Rating Scale dyspareunia score	Change from baseline to 12 weeks of treatment of the mean Numeric Rating Scale((minimum 0, maximum 10, higher score mean a worse outcome) dyspareunia score	12 weeks
Secondary	rescue medication	Change from baseline to 12 weeks of treatment of the use of protocol-defined rescue medication (ie, ibuprofen)	12 weeks
Secondary	Time to increase of dose of rescue medication	Time to increase of dose of rescue medication from 0 week to 12 weeks	12 weeks
Secondary	Time to decrease of dose of rescue medication	Time to decrease of dose of rescue medication from 0 week to 12 weeks	12 weeks
Secondary	Modified Biberoglu and Behrman sign and symptom scores	Change from baseline to 12 weeks of treatment of the Modified Biberoglu and Behrman (mB&B) sign and symptom scores(minimum 0, maximum 3, higher score mean a worse outcome)	12 weeks
Secondary	Patient Global Impression of Change	Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome) at 12 weeks of treatment	12 weeks
Secondary	Endometriosis Health Profile-5	Change from baseline to 12 weeks of treatment in the Endometriosis Health Profile-5 score(minimum 1(Never), maximum 5(Always), higher score mean a worse outcome)	12 weeks
Secondary	36-Item Short Form Health Survey	Change from baseline to 12 weeks of treatment of the 36-Item Short Form Health Survey(Scoring meaning is different from the questions but usually lower score mean a worse outcome)	12 weeks
Secondary	Work Productivity and Activity Impairment Questionnaire: General Health	Change from baseline to 12 weeks of treatment of the Work Productivity and Activity Impairment Questionnaire: General Health (Scoring meaning is different from the questions)	12 weeks