EndometriosisPhase 2NCT05138562
TUC3PII-01_TU2670 Phase IIa Clinical Study
A Phase 2 study testing Active Comparator: TU2670 320mg, Active Comparator: TU2670 240mg and Active Comparator: TU2670 120mg in people with Endometriosis, run by TiumBio Co., Ltd. at 40 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Active Comparator: TU2670 320mg, Active Comparator: TU2670 240mg and Active Comparator: TU2670 120mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 40 sitesin 5 countries
- Study dates
- 19 Aug 2021to 5 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
Poland11 sites
Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o.
Bialystok, Podlaskie Voivodeship, 15224
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Bialystok, 15267
In Vivo sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85090
Centrum Medyczne Mikołowska
Katowice, Silesian Voivodeship, 40065
Provita Sp. z o.o.
Katowice, 40611
Komed Centra Kliniczne
Lublin, Lublin Voivodeship, 20362
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic
Poznan, 60529
Hospital Pro-Familia
Rzeszów, Podkarpackie Voivodeship, 35-302
Gameta Hospital
Rzeszów, Łódź Voivodeship, 95030
Examen sp z o.o.
Skorzewo, Wielkopolska, 60185
Dolnośląskie Centrum Ginekologii
Wroclaw, Lower Silesian Voivodeship, 53333
Czechia8 sites
University Hospital Brno
Brno, 62500
University Hospital Hradec Kralove
Hradec Králové, Hradec Kralove, 50005
Kestr-gyn s.r.o., Gynekologicka ambulance
Náchod, Nachod, 54701
NEUMED gynekologicka ambulance
Olomouc, 77900
Fakultni Nemocnice Kralovske Vinohrady
Prague, Prague, 10034
OB/GYN
Prague, Praha 1, 11000
Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK
Prague, Praha 2, 128 08
Nemocnice Na Bulovce
Prague, 18100
Italy8 sites
University of Florence
Florence, 50129
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
AZIENDA Ospedaliero Univeritaria Di Modena
Modena, 41124
Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula
Monserrato, Cagliari, 09042
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Azienda ospedaliero-universitaria Senese
Siena, Tuscany, 53100
P.O. Sant'Anna
Torino, 10126
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Ukraine8 sites
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
State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
Kiev, 04053
Kyiv city clinical hospital #9, Department of gynecology
Kyiv, 04112
Lviv city clinical hospital #4
Lviv, 79005
Danylo Halytskyy Lviv national medical university
Lviv, 79010
Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child
Vinnytsia, Vinnitsia, 21019
Private Small-Scale Enterprise Medical Centre Pulse
Vinnytsia, 21001
Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council
Zaporizhzhya, Zaporizhzhia Oblast, 69065
Russia5 sites
State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department
Moscow, 115280
FSHI Clinical Hospital #85 of FMBA
Moscow, 115409
Moscow State University of Medicine and Dentistry
Moscow, 127473
SBIH Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry
Yekaterinburg, Sverdlovsk Oblast, 620146
About this 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
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Placebo Comparator: Placebo, Active Comparator: TU2670 320mg, Active Comparator: TU2670 240mg, Active Comparator: TU2670 120mg
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator: PlaceboDrug
4 x placebo capsules, QD
Active Comparator: TU2670 320mgDrug
320mg (80mg x 4), QD
Active Comparator: TU2670 240mgDrug
240mg (80mg x 3 + placebo x 1), QD
Active Comparator: TU2670 120mgDrug
120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 4 Placebo capsules Receives: Drug: Placebo Comparator: Placebo |
| TU2670 High Dose | Active comparator | 320mg, QD Receives: Drug: Active Comparator: TU2670 320mg |
| TU2670 Medium Dose | Active comparator | 240 mg, QD Receives: Drug: Active Comparator: TU2670 240mg |
| TU2670 Low Dose | Active comparator | 120 mg, QD Receives: Drug: Active Comparator: TU2670 120mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (11)
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)
Measured: 12 weeks
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)
Measured: 12 weeks
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
Measured: 12 weeks
rescue medication
Change from baseline to 12 weeks of treatment of the use of protocol-defined rescue medication (ie, ibuprofen)
Measured: 12 weeks
Time to increase of dose of rescue medication
Time to increase of dose of rescue medication from 0 week to 12 weeks
Measured: 12 weeks
Time to decrease of dose of rescue medication
Time to decrease of dose of rescue medication from 0 week to 12 weeks
Measured: 12 weeks
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)
Measured: 12 weeks
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
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start19 Aug 2021
- Primary completion23 Jan 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- TiumBio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138562
- Sponsor's protocol ID
- TUC3PII-01
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2021
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05138562
- Acronym / sponsor ID
- TUC3PII-01
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- TiumBio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Comparator: Placebo4 Placebo capsules |
| TU2670 High Dose | Active comparator | Drug: Active Comparator: TU2670 320mg320mg, QD |
| TU2670 Medium Dose | Active comparator | Drug: Active Comparator: TU2670 240mg240 mg, QD |
| TU2670 Low Dose | Active comparator | Drug: Active Comparator: TU2670 120mg120 mg, QD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Comparator: Placebo4 x placebo capsules, QD | Drug | Placebo |
| Active Comparator: TU2670 320mg320mg (80mg x 4), QD | Drug | TU2670 High Dose |
| Active Comparator: TU2670 240mg240mg (80mg x 3 + placebo x 1), QD | Drug | TU2670 Medium Dose |
| Active Comparator: TU2670 120mg120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD | Drug | TU2670 Low Dose |
Primary outcome
overall pelvic pain
Time frame: 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.
11 secondary outcomes
mean Numeric Rating Scale pain score
Time frame: 12 weeks
mean overall pelvic pain Numeric Rating Scale pain score
Time frame: 12 weeks
mean Numeric Rating Scale dyspareunia score
Time frame: 12 weeks
rescue medication
Time frame: 12 weeks
Time to increase of dose of rescue medication
Time frame: 12 weeks
Time to decrease of dose of rescue medication
Time frame: 12 weeks
Modified Biberoglu and Behrman sign and symptom scores
Time frame: 12 weeks
Patient Global Impression of Change
Time frame: 12 weeks
Endometriosis Health Profile-5
Time frame: 12 weeks
36-Item Short Form Health Survey
Time frame: 12 weeks
Work Productivity and Activity Impairment Questionnaire: General Health
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Comparator: TU2670 320mg, Active Comparator: TU2670 240mg and Active Comparator: TU2670 120mg in people with Endometriosis, run by TiumBio Co., Ltd. at 40 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Poland, Czechia, Italy, Ukraine, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall pelvic pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.