TUC3PII-01_TU2670 Phase IIa Clinical Study
- Conditions
- Endometriosis
- Registration Number
- NCT05138562
- Lead Sponsor
- TiumBio Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method overall pelvic pain 12 weeks 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.
- Secondary Outcome Measures
Name Time Method rescue medication 12 weeks Change from baseline to 12 weeks of treatment of the use of protocol-defined rescue medication (ie, ibuprofen)
Time to increase of dose of rescue medication 12 weeks Time to increase of dose of rescue medication from 0 week to 12 weeks
Patient Global Impression of Change 12 weeks Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome) at 12 weeks of treatment
mean Numeric Rating Scale dyspareunia score 12 weeks 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
Modified Biberoglu and Behrman sign and symptom scores 12 weeks 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)
mean overall pelvic pain Numeric Rating Scale pain score 12 weeks 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)
Time to decrease of dose of rescue medication 12 weeks Time to decrease of dose of rescue medication from 0 week to 12 weeks
Work Productivity and Activity Impairment Questionnaire: General Health 12 weeks 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)
mean Numeric Rating Scale pain score 12 weeks 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)
Endometriosis Health Profile-5 12 weeks 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)
36-Item Short Form Health Survey 12 weeks 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)
Trial Locations
- Locations (40)
NEUMED gynekologicka ambulance
๐จ๐ฟOlomouc, Czechia
Nemocnice Na Bulovce
๐จ๐ฟPrague, Czechia
OB/GYN
๐จ๐ฟPraha, Praha 1, Czechia
Kestr-gyn s.r.o., Gynekologicka ambulance
๐จ๐ฟNรกchod, Nachod, Czechia
University Hospital Hradec Kralove
๐จ๐ฟHradec Krรกlovรฉ, Hradec Kralove, Czechia
Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK
๐จ๐ฟPraha, Praha 2, Czechia
University Hospital Brno
๐จ๐ฟBrno, Czechia
Universitร degli Studi di Cagliari - Policlinico Universitario Duilio Casula
๐ฎ๐นMonserrato, Cagliari, Italy
University of Florence
๐ฎ๐นFlorence, Italy
AZIENDA Ospedaliero Univeritaria Di Modena
๐ฎ๐นModena, Italy
Azienda ospedaliero-universitaria Senese
๐ฎ๐นSiena, Tuscany, Italy
Fondazione IRCCS Cร Granda Ospedale Maggiore Policlinico di Milano
๐ฎ๐นMilano, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
๐ฎ๐นRoma, Italy
Azienda Ospedaliera Universitaria Integrata Verona
๐ฎ๐นVerona, Italy
In Vivo sp. z o.o.
๐ต๐ฑBydgoszcz, Kujawsko-pomorskie, Poland
P.O. Sant'Anna
๐ฎ๐นTorino, Italy
Gameta Hospital
๐ต๐ฑRzeszรณw, Lodzkie, Poland
Komed Centra Kliniczne
๐ต๐ฑLublin, Lubelskie, Poland
Hospital Pro-Familia
๐ต๐ฑRzeszรณw, Podkarpackie, Poland
Examen sp z o.o.
๐ต๐ฑSkorzewo, Wielkopolska, Poland
Provita Sp. z o.o.
๐ต๐ฑKatowice, Poland
Klinika Leczenia Niepลodnoลci, Ginekologii i Poลoลผnictwa Bocian, Fertility Clinic
๐ต๐ฑPoznaล, Poland
Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry
๐ท๐บEkaterinburg, Sverdlovskaya Oblast, Russian Federation
Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council
๐บ๐ฆIvano-Frankivs'k, Ivano-Frankivsk, Ukraine
SBIH Leningrad Regional Clinical Hospital
๐ท๐บSaint Petersburg, Russian Federation
State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
๐บ๐ฆKiev, Ukraine
Kyiv city clinical hospital #9, Department of gynecology
๐บ๐ฆKyiv, Ukraine
Lviv city clinical hospital #4
๐บ๐ฆLviv, Ukraine
Danylo Halytskyy Lviv national medical university
๐บ๐ฆLviv, Ukraine
Private Small-Scale Enterprise Medical Centre Pulse
๐บ๐ฆVinnytsia, Ukraine
Fakultni Nemocnice Kralovske Vinohrady
๐จ๐ฟPraha 10, Praha, Czechia
Dolnoลlฤ skie Centrum Ginekologii
๐ต๐ฑWrocลaw, Dolnoลlฤ skie, Poland
Prywatna Klinika Poลoลผniczo-Ginekologiczna Sp. z o.o.
๐ต๐ฑBiaลystok, Podlaskie, Poland
Centrum Medyczne Mikoลowska
๐ต๐ฑKatowice, Silesia, Poland
Klinika Leczenia Niepลodnoลci, Ginekologii i Poลoลผnictwa Bocian
๐ต๐ฑBiaลystok, Poland
State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department
๐ท๐บMoscow, Russian Federation
Moscow State University of Medicine and Dentistry
๐ท๐บMoscow, Russian Federation
Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child
๐บ๐ฆVinnytsia, Vinnitsia, Ukraine
FSHI Clinical Hospital #85 of FMBA
๐ท๐บMoscow, Russian Federation
Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council
๐บ๐ฆZaporizhzhya, Zaporizhzhya Oblast, Ukraine