Elagolix + COC for Endometriosis

(ELARIS EM-COC Trial)

Recruiting at 103 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Combined oral contraceptives

Disqualifiers: Pregnancy, Hysterectomy, Osteoporosis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

Trial Summary

What is the purpose of this trial?

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you must agree to use non-hormonal contraception during certain periods of the study, which might affect your current medication use.

What data supports the effectiveness of the drug Elagolix for treating endometriosis?

Elagolix has been shown to significantly reduce pain associated with endometriosis, including menstrual pain and non-menstrual pelvic pain, and improve quality of life for women with this condition. It works by lowering hormone levels that contribute to the growth of endometrial tissue outside the uterus. ^{1 2 3 4 5}

What makes the drug Elagolix unique for treating endometriosis?

Elagolix is unique because it is an oral medication that works by blocking certain hormone receptors, reducing levels of hormones like estrogen and progesterone, which helps decrease inflammation and the growth of endometrial tissue. This mechanism is different from other treatments that may not target hormone suppression directly. ^{1 2 5 6 7}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adult women who have endometriosis with moderate to severe pain and are suitable candidates for combined oral contraceptives (COCs). They must not be pregnant, breastfeeding, or planning pregnancy until the study ends. Participants should not have had a hysterectomy or oophorectomy, osteoporosis, other metabolic bone diseases, or any chronic pain conditions that could affect their pain assessment.

Inclusion Criteria

Documented surgical confirmation of endometriosis and associated moderate to severe pain.

Have you been surgically diagnosed with Endometriosis and have documentation?

Are your menstrual cycles regular, meaning every 21-35 days?

Exclusion Criteria

Are you currently breastfeeding, pregnant, or planning a pregnancy.

You have been diagnosed with PCOS

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive double-blind elagolix or placebo in combination with COC for 3 months

3 months

Regular visits at a hospital or clinic

Open-Label Treatment

All participants receive open-label elagolix in combination with COC for 15 months

15 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Combined Oral Contraceptive (COC)
• Elagolix
• Placebo for COC
• Placebo for Elagolix

Trial Overview The study tests how well elagolix works with COCs compared to a placebo in managing painful periods due to endometriosis. About 800 participants will be randomly assigned to one of three groups: two receiving different treatments and one receiving a placebo. After three months on varied regimens, all participants will receive elagolix with COCs from Month 4 through Month 18.

Participant Groups

Group I: Double-Blind: Elagolix + COC Experimental Treatment 2 Interventions

Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.

Group II: Double-Blind: Elagolix Experimental Treatment 2 Interventions

Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.

Group III: Double-Blind: Placebo Placebo Group 3 Interventions

Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.

Elagolix is already approved in United States for the following indications:

Approved in United States as Orilissa for:

• Management of moderate to severe pain associated with endometriosis

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Elagolix (Orilissa) is an FDA-approved oral treatment for endometriosis-related pain that works by blocking gonadotropin-releasing hormone receptors, leading to reduced hormone levels and decreased inflammation of endometrial tissue.

This medication is significant for the estimated 10% of reproductive-age women affected by endometriosis, as it addresses symptoms like chronic pelvic pain and dysmenorrhea, although it also has contraindications and potential adverse effects that healthcare providers need to consider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elagolix as a Novel Treatment for Endometriosis-Related Pain. Fantasia, HC.[2020]

Elagolix (ORILISSA™) is an FDA-approved oral medication for managing moderate to severe pain from endometriosis, based on positive results from two phase III trials.

It is currently being tested in additional phase III trials for both endometriosis and heavy menstrual bleeding associated with uterine fibroids, indicating its potential for broader applications in treating reproductive hormone-dependent disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elagolix: First Global Approval. Lamb, YN.[2019]

After 12 months of treatment with elagolix, 52.1% of women taking 150 mg once daily and 78.2% taking 200 mg twice daily reported significant reductions in dysmenorrhea, indicating its efficacy in managing endometriosis-associated pain.

The treatment was generally safe, with no new safety concerns identified; however, some participants experienced decreased bone mineral density and increased lipid levels, which are consistent with reduced estrogen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Surrey, E., Taylor, HS., Giudice, L., et al.[2019]

In two phase III trials involving patients with moderate to severe endometriosis pain, elagolix significantly improved health-related quality of life (HRQOL) as measured by the EHP-30 questionnaire, with the 200 mg dose showing the greatest improvements across multiple subscales compared to placebo.

Both doses of elagolix (150 mg and 200 mg) led to clinically meaningful improvements in pain and emotional well-being, with the 200 mg group showing up to 169% higher probabilities of achieving these improvements at 6 months, indicating its efficacy in managing endometriosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Taylor, HS., Soliman, AM., Johns, B., et al.[2022]

Elagolix, a GnRH receptor antagonist, significantly reduces dysmenorrhea and non-menstrual pelvic pain in women with moderate to severe endometriosis, based on pooled data from over 1600 participants in two 6-month phase 3 studies.

The treatment was effective across various subgroups, with significant improvements in pain reported at 3 months and enhancements in health-related quality of life, indicating its broad applicability for different women with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. Abrao, MS., Surrey, E., Gordon, K., et al.[2022]

A novel and sensitive LC-MS-compatible method was developed to quantify organic impurities in elagolix sodium tablets, achieving significant resolution of impurities in just 46 minutes.

The method demonstrated high stability and specificity, effectively identifying major degradation products under various stress conditions, making it suitable for quality control in pharmaceutical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LC-MS-Compatible Chromatographic Method for Quantification of Potential Organic Impurities of Elagolix Sodium in Tablet Dosage Form with Identification of Major Degradation Products. Desai, P., Prajapati, R., Chokshi, A.[2023]

Elagolix effectively suppresses ovulation in a dose-dependent manner, with the lowest ovulation rates observed at higher doses (27% at 300 mg BID), indicating its potential as a contraceptive method for women with endometriosis.

The treatment also leads to significant suppression of key hormones like luteinizing hormone and estradiol, but does not affect ovarian reserve, suggesting it may be a safe option for managing endometriosis-associated pain without compromising fertility in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. Archer, DF., Ng, J., Chwalisz, K., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Elagolix as a Novel Treatment for Endometriosis-Related Pain. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Elagolix: First Global Approval. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

LC-MS-Compatible Chromatographic Method for Quantification of Potential Organic Impurities of Elagolix Sodium in Tablet Dosage Form with Identification of Major Degradation Products. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. [2020]