TUC3PII-01_TU2670 Phase IIa Clinical Study

Phase 2

Completed

• 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.

Study Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-12-01
• Primary Completion: 2024-01-23
• Status Verified: 2024-08
• Study Completion: 2024-08-05
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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.

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)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Hradec Kralove, Czechia

Kestr-gyn s.r.o., Gynekologicka ambulance; 🇨🇿 Náchod, Nachod, 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, Czechia

University Hospital Brno; 🇨🇿 Brno, Czechia

NEUMED gynekologicka ambulance; 🇨🇿 Olomouc, Czechia

Nemocnice Na Bulovce; 🇨🇿 Prague, Czechia

Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula; 🇮🇹 Monserrato, Cagliari, Italy

Azienda ospedaliero-universitaria Senese; 🇮🇹 Siena, Tuscany, Italy

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