TUC3PII-01_TU2670 Phase IIa Clinical Study

Sponsor

TiumBio Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05138562

Collaborator

(none)

Enrollment

Locations

Arms

28.4

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Placebo Comparator: Placebo Drug: Active Comparator: TU2670 320mg Drug: Active Comparator: TU2670 240mg Drug: Active Comparator: TU2670 120mg	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 19, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 4 Placebo capsules	Drug: Placebo Comparator: Placebo 4 x placebo capsules, QD
Active Comparator: TU2670 High Dose 320mg, QD	Drug: Active Comparator: TU2670 320mg 320mg (80mg x 4), QD
Active Comparator: TU2670 Medium Dose 240 mg, QD	Drug: Active Comparator: TU2670 240mg 240mg (80mg x 3 + placebo x 1), QD
Active Comparator: TU2670 Low Dose 120 mg, QD	Drug: Active Comparator: TU2670 120mg 120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD

Outcome Measures

Primary Outcome Measures

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

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)
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)
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
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
Time to decrease of dose of rescue medication [12 weeks]
Time to decrease of dose of rescue medication from 0 week to 12 weeks
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)
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
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)
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)

Other Outcome Measures

Bone mineral density loss [12 weeks]
Change from baseline to 12 weeks of treatment of the bone mineral density as assessed by dual-energy X-ray absorptiometry (DXA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Králové	Hradec Kralove	Czechia	50005
2	Kestr-gyn s.r.o., Gynekologicka ambulance	Náchod	Nachod	Czechia	54701
3	OB/GYN	Praha	Praha 1	Czechia	11000
4	Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK	Praha	Praha 2	Czechia	128 08
5	Fakultni Nemocnice Kralovske Vinohrady	Praha 10	Praha	Czechia	10034
6	University Hospital Brno	Brno		Czechia	62500
7	NEUMED gynekologicka ambulance	Olomouc		Czechia	77900
8	Nemocnice Na Bulovce	Prague		Czechia	18100
9	Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula	Monserrato	Cagliari	Italy	09042
10	Azienda ospedaliero-universitaria Senese	Siena	Tuscany	Italy	53100
11	University of Florence	Florence		Italy	50129
12	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano	Milano		Italy	20122
13	AZIENDA Ospedaliero Univeritaria Di Modena	Modena		Italy	41124
14	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma		Italy	00168
15	P.O. Sant'Anna	Torino		Italy	10126
16	Azienda Ospedaliera Universitaria Integrata Verona	Verona		Italy	37126
17	Dolnośląskie Centrum Ginekologii	Wrocław	Dolnośląskie	Poland	53333
18	In Vivo sp. z o.o.	Bydgoszcz	Kujawsko-pomorskie	Poland	85090
19	Gameta Hospital	Rzeszów	Lodzkie	Poland	95030
20	Komed Centra Kliniczne	Lublin	Lubelskie	Poland	20362
21	Hospital Pro-Familia	Rzeszów	Podkarpackie	Poland	35-302
22	Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o.	Białystok	Podlaskie	Poland	15224
23	Centrum Medyczne Mikołowska	Katowice	Silesia	Poland	40065
24	Examen sp z o.o.	Skorzewo	Wielkopolska	Poland	60185
25	Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian	Białystok		Poland	15267
26	Provita Sp. z o.o.	Katowice		Poland	40611
27	Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic	Poznań		Poland	60529
28	Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry	Ekaterinburg	Sverdlovskaya Oblast	Russian Federation	620146
29	State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department	Moscow		Russian Federation	115280
30	FSHI Clinical Hospital #85 of FMBA	Moscow		Russian Federation	115409
31	Moscow State University of Medicine and Dentistry	Moscow		Russian Federation	127473
32	SBIH Leningrad Regional Clinical Hospital	Saint Petersburg		Russian Federation	194291
33	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	76018
34	Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child	Vinnytsia	Vinnitsia	Ukraine	21019
35	Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council	Zaporizhzhya	Zaporizhzhya Oblast	Ukraine	69065
36	State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine	Kiev		Ukraine	04053
37	Kyiv city clinical hospital #9, Department of gynecology	Kyiv		Ukraine	04112
38	Lviv city clinical hospital #4	Lviv		Ukraine	79005
39	Danylo Halytskyy Lviv national medical university	Lviv		Ukraine	79010
40	Private Small-Scale Enterprise Medical Centre Pulse	Vinnytsia		Ukraine	21001

Sponsors and Collaborators

TiumBio Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TiumBio Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05138562

Other Study ID Numbers:

TUC3PII-01

First Posted:

Dec 1, 2021

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Dec 1, 2021