Clinical trial NCT05138562: TUC3PII-01_TU2670 Phase IIa Clinical Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: TiumBio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: overall pelvic pain
timeFrame: 12 weeks
Secondary outcomes:
measure: mean Numeric Rating Scale pain score
timeFrame: 12 weeks
measure: mean overall pelvic pain Numeric Rating Scale pain score
timeFrame: 12 weeks
measure: mean Numeric Rating Scale dyspareunia score
timeFrame: 12 weeks
measure: rescue medication
timeFrame: 12 weeks
measure: Time to increase of dose of rescue medication
timeFrame: 12 weeks
measure: Time to decrease of dose of rescue medication
timeFrame: 12 weeks
measure: Modified Biberoglu and Behrman sign and symptom scores
timeFrame: 12 weeks
measure: Patient Global Impression of Change
timeFrame: 12 weeks
measure: Endometriosis Health Profile-5
timeFrame: 12 weeks
measure: 36-Item Short Form Health Survey
timeFrame: 12 weeks
measure: Work Productivity and Activity Impairment Questionnaire: General Health
timeFrame: 12 weeks
Other outcomes:
measure: Bone mineral density loss
timeFrame: 12 weeks
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Hradec Kralove
city: Náchod
country: Czechia
facility: Kestr-gyn s.r.o., Gynekologicka ambulance
state: Nachod
city: Praha
country: Czechia
facility: OB/GYN
state: Praha 1
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK
state: Praha 2
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
state: Praha
city: Brno
country: Czechia
facility: University Hospital Brno
city: Olomouc
country: Czechia
facility: NEUMED gynekologicka ambulance
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Monserrato
country: Italy
facility: Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula
state: Cagliari
city: Siena
country: Italy
facility: Azienda ospedaliero-universitaria Senese
state: Tuscany
city: Florence
country: Italy
facility: University of Florence
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano
city: Modena
country: Italy
facility: AZIENDA Ospedaliero Univeritaria Di Modena
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Torino
country: Italy
facility: P.O. Sant'Anna
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Wrocław
country: Poland
facility: Dolnośląskie Centrum Ginekologii
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: In Vivo sp. z o.o.
state: Kujawsko-pomorskie
city: Rzeszów
country: Poland
facility: Gameta Hospital
state: Lodzkie
city: Lublin
country: Poland
facility: Komed Centra Kliniczne
state: Lubelskie
city: Rzeszów
country: Poland
facility: Hospital Pro-Familia
state: Podkarpackie
city: Białystok
country: Poland
facility: Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o.
state: Podlaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Mikołowska
state: Silesia
city: Skorzewo
country: Poland
facility: Examen sp z o.o.
state: Wielkopolska
city: Białystok
country: Poland
facility: Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
city: Katowice
country: Poland
facility: Provita Sp. z o.o.
city: Poznań
country: Poland
facility: Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic
city: Ekaterinburg
country: Russian Federation
facility: Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry
state: Sverdlovskaya Oblast
city: Moscow
country: Russian Federation
facility: State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department
city: Moscow
country: Russian Federation
facility: FSHI Clinical Hospital #85 of FMBA
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
city: Saint Petersburg
country: Russian Federation
facility: SBIH Leningrad Regional Clinical Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council
state: Ivano-Frankivsk
city: Vinnytsia
country: Ukraine
facility: Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child
state: Vinnitsia
city: Zaporizhzhya
country: Ukraine
facility: Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council
state: Zaporizhzhya Oblast
city: Kiev
country: Ukraine
facility: State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv city clinical hospital #9, Department of gynecology
city: Lviv
country: Ukraine
facility: Lviv city clinical hospital #4
city: Lviv
country: Ukraine
facility: Danylo Halytskyy Lviv national medical university
city: Vinnytsia
country: Ukraine
facility: Private Small-Scale Enterprise Medical Centre Pulse
Study officials:
References: