E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Endometriosis Associated Pain |
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E.1.1.1 | Medical condition in easily understood language |
Endometriosis Associated Pain |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014788 |
E.1.2 | Term | Endometriosis related pain |
E.1.2 | System Organ Class | 100000004872 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this 6-month extension study is to evaluate the continued safety, efficacy and tolerability of the 150 mg QD and 200 mg BID doses of elagolix (ABT-620) for up to 12 months in the management of moderate to severe endometriosis-associated pain. Safety and tolerability will include assessments of BMD via dual-energy x-ray absorptiometry (DXA) including effects of long term treatment and post-treatment recovery during an up to 12-month Post-Treatment Period and evaluation of endometrial health via transvaginal ultrasound (TVU). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess the population PK and PD of elagolix. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board/Ethics Committee (IRB/EC) prior to initiation of any study-specific procedures.
2. Subject has completed the 6-Month Treatment Period in pivotal study M12-671.
3. Subject must agree to use two forms of non-hormonal contraception (dual contraception) consistently during the Treatment and the Post-Treatment Follow-Up Periods (through Month 6).
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E.4 | Principal exclusion criteria |
1. Pivotal study M12-671 Month 6 TVU or other diagnostic procedure shows clinically significant gynecological condition
2. Subject has BMD loss ≥ 8% in the spine, femoral neck or total hip as specified per the algorithm for Management of Bone Loss at Month 6 of the Treatment Period in pivotal Study M12-671.
3. Subject met criteria for removal from therapy in pivotal Study M12-671.
4. Subject plans to become pregnant in the next 18 months.
5. Subject will be unable or unwilling to comply with study-related assessments and procedures
6. Subject has a newly diagnosed or clinically significant medical condition that requires intervention OR an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of responders at each month based upon the mutually-exclusive scales for daily assessment of DYS and NMPP measured by the Daily Assessment of Endometriosis Pain (modified Biberoglu and Behrman [B&B] scales using the e-Diary); use of analgesic medication for endometriosis-associated pain will be included in the responder definition. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, Month 1-Month 6 in the treatment periood and Month 1-Month6 in the Post-Treatment Follow-Up Period. |
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E.5.2 | Secondary end point(s) |
• Proportion of responders at each month for dyspareunia as assessed by the e-Diary.
• Change from baseline to each month in DYS, as assessed by the e-Diary.
• Change from baseline to each month in NMPP, as assessed by the e-Diary.
• Change from baseline to each month in dyspareunia, as assessed by the e-Diary.
• Change from baseline to each month in analgesic use to treat endometriosis-related pain, as assessed by the e-Diary.
• Results of Endometriosis Health Profile-30(EHP-30) domain of pain at each assessed visit.
• Results of EHP-30 domain of sexual relationship at each assessed visit
• Summary of Health Related Productivity Questionnaire scores by visit (HRPQ).
• Endometriosis related number of non-study health visits, number of days in hospital and type of procedures performed based on Health Resource Utilization Questionnaire (HRUQ).
• Change from baseline to each month in Numeric Rating Scale (NRS) scores, as assessed by the e-Diary.
• Response at each month to the Patient Global Impression of Change (PGIC) questionnaire.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Treatment Period until Month 6/PD. During the Post-Treatment Follow-Up Period, daily assessments will be recorded in the e Diary through Follow-Up Month 6. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Two doses of Elagolix 150 mg QD and 200 mg BID |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 69 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Brazil |
Czech Republic |
Hungary |
Italy |
New Zealand |
Poland |
South Africa |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 24 |